<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03261700</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 16-062</org_study_id>
    <secondary_id>1I01HX002178-01A1</secondary_id>
    <nct_id>NCT03261700</nct_id>
  </id_info>
  <brief_title>Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE)</brief_title>
  <acronym>RISE</acronym>
  <official_title>Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE): Tailoring and Evaluating a Patient-Centered Counseling Intervention for Women Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VA Boston Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intimate partner violence (IPV) is a major health concern for women Veterans. IPV is&#xD;
      associated with numerous physical and mental health conditions. VHA is implementing IPV&#xD;
      screening programs to identify female patients who experience past-year IPV. Despite strong&#xD;
      evidence that screening increases detection of IPV, less is established about how to&#xD;
      intervene following IPV disclosure in health care settings, in order to improve health&#xD;
      outcomes. Existing healthcare-based interventions result in minimal effects on health and&#xD;
      well-being, likely because they are too brief and generic.&#xD;
&#xD;
      In response, the PI has developed Recovering from IPV through Strengths and Empowerment&#xD;
      (RISE), based on the IPV-related health care needs and preferences of women Veterans. RISE is&#xD;
      designed to be delivered in primary care and is an individualized, variable-length,&#xD;
      modular-based intervention that addresses&#xD;
&#xD;
        -  safety planning;&#xD;
&#xD;
        -  education on the health effects of IPV and warning signs;&#xD;
&#xD;
        -  increasing coping skills and self-care;&#xD;
&#xD;
        -  enhancing social support;&#xD;
&#xD;
        -  making difficult decisions; and&#xD;
&#xD;
        -  connecting with resources. This study is aimed at refining and evaluating RISE for use&#xD;
           with female VA patients who have experienced past-year IPV. This brief counseling&#xD;
           intervention is intended to be administered in conjunction with primary care, as this is&#xD;
           a frequent point of healthcare contact for women Veterans and where disclosure of IPV is&#xD;
           most prevalent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women are the fastest growing group of VHA patients, with their population recently&#xD;
      increasing by 80%. Women Veterans (WV's) are at higher risk for IPV than their non-Veteran&#xD;
      peers, with that 1 in 3 WVs report lifetime IPV, compared to 1 in 4 women in the general U.S.&#xD;
      population. Research reports up to 30% of WVs experience past-year IPV. As a result, WVs are&#xD;
      considered an important population for IPV screening and counseling interventions. In&#xD;
      response, VHA Women's Health Services (WHS) and the IPV Assistance Program of Care Management&#xD;
      and Social Work Services (CMSWS) are implementing IPV screening programs for women and are&#xD;
      seeking an effective intervention to implement into care. Extant brief counseling&#xD;
      interventions for IPV result in minimal effects on patients' health and safety. A recent&#xD;
      review of IPV screening trials highlighted insufficient intensity of post-disclosure&#xD;
      counseling interventions, concluding that existing interventions are too brief, unstructured,&#xD;
      and generic. Such minimal intervention effects of the current standard of care have led&#xD;
      leaders in the field to call for the development and testing of new and more comprehensive&#xD;
      IPV interventions, especially for delivery in conjunction with primary care. The Recovering&#xD;
      from IPV through Strengths and Empowerment (RISE) intervention fills this need.&#xD;
&#xD;
      The PI, a clinical psychologist and health services researcher with expertise in and national&#xD;
      recognition for IPV research and care, has developed an innovative IPV intervention to&#xD;
      respond to this need. Recovering from IPV through Strengths and Empowerment (RISE) is based&#xD;
      on the healthcare needs and preferences of WVs who have experienced IPV. RISE was developed&#xD;
      using rigorous methods, building on the evidence base from the applicant's HSR&amp;D CDA and on&#xD;
      input of VHA primary care and behavioral health experts. RISE is based on empowerment, a&#xD;
      highly relevant intervention model for women who experience IPV. It is an individualized,&#xD;
      variable-length, modular-based intervention addressing key factors:&#xD;
&#xD;
        -  safety planning,&#xD;
&#xD;
        -  educating about the health effects of IPV and warning signs,&#xD;
&#xD;
        -  improving coping and self-care,&#xD;
&#xD;
        -  enhancing social support,&#xD;
&#xD;
        -  making difficult decisions, and&#xD;
&#xD;
        -  connecting with resources. RISE is rooted in empowerment and incorporates aspects of&#xD;
           Motivational Interviewing, an evidence-based approach designed to facilitate behavior&#xD;
           change that is widely used in VHA for numerous health issues.&#xD;
&#xD;
      This timely research project addresses the critical gap in current IPV care. It will refine&#xD;
      and formally evaluate RISE using established methods for rapid and efficient effectiveness&#xD;
      testing, including a Hybrid 1 randomized clinical trial (RCT) to evaluate RISE that&#xD;
      simultaneously gathers information on barriers to and facilitators of implementation. The&#xD;
      study is guided by the first two phases of the Replicating Effective Programs (REP)&#xD;
      framework, pre-conditions and pre-implementation. These phases emphasize tailoring&#xD;
      interventions with stakeholder input and iterative cycles of pilot testing within routine&#xD;
      practice conditions. Use of the REP framework will maximize the likelihood that RISE-should&#xD;
      its effectiveness be demonstrated-can easily be integrated into routine care in VHA.&#xD;
&#xD;
      The Specific Aims of this study are as follows:&#xD;
&#xD;
        1. Tailor and refine RISE to accommodate differences in service structures and personnel in&#xD;
           different primary care settings through input from a Stakeholder Advisory Board, focus&#xD;
           groups with WVs (four groups; n=24-32), and qualitative interviews with providers&#xD;
           (n=24).&#xD;
&#xD;
        2. Conduct a formative evaluation of RISE with WVs (n=up to 20) to inform the development&#xD;
           of a user-friendly, tailored implementation protocol and intervention manual.&#xD;
&#xD;
        3. Examine the effects of RISE on WVs' (n=60) individual psychosocial outcomes (e.g.,&#xD;
           empowerment, self-efficacy, health symptoms, service use, and quality of life) in an RCT&#xD;
           that compares RISE to an information/referral condition.&#xD;
&#xD;
      3a. Evaluate the feasibility and acceptability of RISE in the context of the RCT.&#xD;
&#xD;
      This study provides the groundwork to examine the effectiveness of RISE. The data will be&#xD;
      used to demonstrate whether the effects of RISE appear promising to support a future-large&#xD;
      scale effectiveness-implementation RCT, including the range of effect sizes that would be&#xD;
      reasonable to expect in a future trial.&#xD;
&#xD;
      The project was originally conducted at two Women's Health Practice-Based Research Network&#xD;
      (PBRN) sites that have adopted IPV screening - the Women's Health Centers (WHC) at VA Boston&#xD;
      Healthcare System and VA Connecticut Healthcare System. RCT study enrollment was discontinued&#xD;
      at VA Connecticut in July 2019 due to low enrollment. The VA Boston Healthcare System serves&#xD;
      as the sole site for data collection from July 2019 on and is the sourced of the RCT data.&#xD;
&#xD;
      The COVID-19 pandemic resulted in modifications to IRB protocol to switch from in-person&#xD;
      enrollment, assessments and sessions. There were several women actively involved in the trial&#xD;
      during the initial shut-down. New recruitment and enrollment were temporarily hauled during&#xD;
      early months of COVID-19, with virtual enrollment beginning as of July 2020.&#xD;
&#xD;
      Recruitment and enrollment were completed in September 2020 because the enrollment goals were&#xD;
      met and the planned sample size was obtained (N=60).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 22, 2018</start_date>
  <completion_date type="Actual">November 23, 2020</completion_date>
  <primary_completion_date type="Actual">November 23, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>For the RCT (Aim 3), participants will be randomized to RISE or an information and referral condition.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Empowerment Via the Personal Progress Scale Revised</measure>
    <time_frame>Baseline,10-week follow-up, and 14-week follow-up assessments</time_frame>
    <description>Measures change in sense of personal empowerment; minimum value = 28 and maximum score = 196; higher scores indicate higher personal empowerment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-efficacy Via the General Self-Efficacy Scale</measure>
    <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
    <description>This scale is a self-report of change in general self-efficacy; minimum score = 4 and maximum score = 40; higher scores indicate higher self-efficacy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Valued Living Questionnaire</measure>
    <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
    <description>Measures change in valued living, and congruence between stated values and past-week valued behavior; Composite scores range from 10 (minimum) to 100 (maximum). Higher scores reflect higher valued living (i.e., an indicator of higher quality of life)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Activation Measure (PAM-13)</measure>
    <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
    <description>Measures change in patient engagement in needed health care; scores are transferred to a theoretical 0-100 scale; higher scores indicate higher patient activation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PTSD Checklist for DSM-5</measure>
    <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
    <description>Measures change in DSM-5 PTSD symptom severity. Scores range from 0-80; higher scores reflect higher/worse PTSD symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Center for Epidemiological Studies-Depression Scale</measure>
    <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
    <description>Measures change in depressive symptoms; This measure ranges from 0-60; higher scores reflect (worse) higher levels of symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12 Health Survey</measure>
    <time_frame>Baseline, 10-Week follow-up, and 14-Week follow-up Assessments</time_frame>
    <description>Measures change in physical-health related quality of life. Specifically, quantitative ratings of overall physical health functioning were rated on a Likert scale of 1-5 (1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conflict Tactic Scales Revised</measure>
    <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
    <description>Measures change in overall number of different IPV acts over time (i.e., total count score). This measure ranges from 0-33; higher scores reflect higher levels of IPV (i.e., a worse outcome).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical, Mental and Social Service Care Use</measure>
    <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
    <description>Measures overall number of VA and non-VA health care visits (inclusive of physical, mental health, and social service use visits).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Services Questionnaire (CSQ-8)</measure>
    <time_frame>10-week follow-up assessment</time_frame>
    <description>Measures satisfaction with treatment; Scores range from 8 to 32; higher scores reflect higher satisfaction with treatment (i.e., a better outcome)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire</measure>
    <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
    <description>Measures change in somatic and physical health symptoms; score ranges from 0 to 30, with higher scores representing higher levels of physical health problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Behaviors Checklist</measure>
    <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
    <description>Measures the present use of safety behaviors participants are currently using to protect themselves. Each of the 15 items of this measure corresponds to a specific safety behavior. Participant indicates whether they have used each behavior using a dichotomous response option (yes = 1; no = 0). Scores are summed, with total scores ranging from 0-15. Higher scores indicate a higher number of safety behaviors enacted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Connor-Davidson Resilience Scale</measure>
    <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
    <description>Measures patient resilience; Scores range from 0-100,with higher scores reflecting higher resilience</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression Anxiety Stress Scale- Anxiety Subscale</measure>
    <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
    <description>Measures anxiety symptom severity; Scores range from 0-42, with higher scores indicating higher levels of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Coping Strategies Inventory - Short Form</measure>
    <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
    <description>Measures engagement coping skills; Scores range from 8-40, with higher score reflecting better coping</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.</measure>
    <time_frame>Assessed at 10-week follow-up or 14-week follow-up, values at the end of 14 weeks reported</time_frame>
    <description>Semi-structured qualitative interview questions developed for the purpose of this study to assess participants' perceptions of the acceptability, with a particular item to assess overall helpfulness of the intervention. Specifically, quantitative ratings of overall helpfulness were rated on a Likert scale of 1-5 (1=highly helpful, 2 = somewhat helpful, 3 = neither helpful nor unhelpful, 4 = somewhat unhelpful, 5=highly unhelpful).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Intimate Partner Violence</condition>
  <condition>Self-efficacy</condition>
  <arm_group>
    <arm_group_label>RISE</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This provider- administered brief- counseling intervention program will increase Women Veteran?s self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Information and referral condition</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>RISE</intervention_name>
    <description>This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
    <arm_group_label>RISE</arm_group_label>
    <other_name>Recovering from IPV through Strengths and Empowerment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Information and referral condition</intervention_name>
    <description>Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
    <arm_group_label>Information and referral condition</arm_group_label>
    <other_name>Control condition</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants will be eligible to participate if they:&#xD;
&#xD;
          -  Self-identify as a woman&#xD;
&#xD;
          -  Are at least 18 years of age&#xD;
&#xD;
          -  A patient at VA Boston Healthcare System&#xD;
&#xD;
          -  Self- reported that they have experienced past-year physical, sexual, or psychological&#xD;
             IPV&#xD;
&#xD;
          -  Ability to understand study procedures in English&#xD;
&#xD;
          -  Not exhibiting symptoms of mania or psychosis&#xD;
&#xD;
          -  Not actively in suicidal crisis warranting imminent hospitalization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any violation of inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self-identify as female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine M. Iverson, PhD MA BA</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02130-4817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dardis CM, Dichter ME, Iverson KM. Empowerment, PTSD and revictimization among women who have experienced intimate partner violence. Psychiatry Res. 2018 Aug;266:103-110. doi: 10.1016/j.psychres.2018.05.034. Epub 2018 May 30.</citation>
    <PMID>29859496</PMID>
  </reference>
  <reference>
    <citation>Grillo AR, Danitz SB, Dichter ME, Driscoll MA, Gerber MR, Hamilton AB, Wiltsey-Stirman S, Iverson KM. Strides Toward Recovery From Intimate Partner Violence: Elucidating Patient-Centered Outcomes to Optimize a Brief Counseling Intervention for Women. J Interpers Violence. 2021 Aug;36(15-16):NP8431-NP8453. doi: 10.1177/0886260519840408. Epub 2019 Apr 17.</citation>
    <PMID>30994401</PMID>
  </reference>
  <reference>
    <citation>Iverson KM, Dardis CM, Grillo AR, Galovski TE, Pogoda TK. Associations between traumatic brain injury from intimate partner violence and future psychosocial health risks in women. Compr Psychiatry. 2019 Jul;92:13-21. doi: 10.1016/j.comppsych.2019.05.001. Epub 2019 May 14.</citation>
    <PMID>31203176</PMID>
  </reference>
  <reference>
    <citation>Danitz SB, Stirman SW, Grillo AR, Dichter ME, Driscoll M, Gerber MR, Gregor K, Hamilton AB, Iverson KM. When user-centered design meets implementation science: integrating provider perspectives in the development of an intimate partner violence intervention for women treated in the United States' largest integrated healthcare system. BMC Womens Health. 2019 Nov 27;19(1):145. doi: 10.1186/s12905-019-0837-8.</citation>
    <PMID>31771557</PMID>
  </reference>
  <reference>
    <citation>Iverson KM, Danitz SB, Driscoll M, Vogt D, Hamilton AB, Gerber MR, Wiltsey Stirman S, Shayani DR, Suvak MK, Dichter ME. Recovering from intimate partner violence through Strengths and Empowerment (RISE): Development, pilot testing, and refinement of a patient-centered brief counseling intervention for women. Psychol Serv. 2022;19(Suppl 2):102-112. doi: 10.1037/ser0000544. Epub 2021 Jun 10.</citation>
    <PMID>34110870</PMID>
  </reference>
  <results_reference>
    <citation>Iverson KM, Danitz SB, Shayani DR, Vogt D, Stirman SW, Hamilton AB, Mahoney CT, Gerber MR, Dichter ME. Recovering From Intimate Partner Violence Through Strengths and Empowerment: Findings From a Randomized Clinical Trial. J Clin Psychiatry. 2021 Nov 23;83(1):21m14041. doi: 10.4088/JCP.21m14041.</citation>
    <PMID>34813687</PMID>
  </results_reference>
  <results_reference>
    <citation>Shayani DR, Danitz SB, Low SK, Hamilton AB, Iverson KM. Women Tell All: A Comparative Thematic Analysis of Women's Perspectives on Two Brief Counseling Interventions for Intimate Partner Violence. Int J Environ Res Public Health. 2022 Feb 22;19(5):2513. doi: 10.3390/ijerph19052513.</citation>
    <PMID>35270204</PMID>
  </results_reference>
  <results_reference>
    <citation>Davin KR, Dardis CM, Barth MR, Iverson KM. Prospective mental health effects of intimate partner stalking among women veterans. Psychol Trauma. 2022 Jul;14(5):751-758. doi: 10.1037/tra0001144. Epub 2021 Nov 4.</citation>
    <PMID>34735188</PMID>
  </results_reference>
  <results_reference>
    <citation>Iverson KM, Dardis CM, Cowlishaw S, Webermann AR, Shayani DR, Dichter ME, Mitchell KS, Mattocks KM, Gerber MR, Portnoy GR. Effects of Intimate Partner Violence During COVID-19 and Pandemic-Related Stress on the Mental and Physical Health of Women Veterans. J Gen Intern Med. 2022 Sep;37(Suppl 3):724-733. doi: 10.1007/s11606-022-07589-z. Epub 2022 Aug 30.</citation>
    <PMID>36042090</PMID>
  </results_reference>
  <results_reference>
    <citation>Webermann AR, Dardis CM, Iverson KM. The role of general self-efficacy in intimate partner violence and symptoms of posttraumatic stress disorder among women veterans. J Trauma Stress. 2022 Jun;35(3):868-878. doi: 10.1002/jts.22794. Epub 2022 Jan 31.</citation>
    <PMID>35099821</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <results_first_submitted>December 1, 2021</results_first_submitted>
  <results_first_submitted_qc>June 15, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 30, 2023</results_first_posted>
  <last_update_submitted>July 26, 2023</last_update_submitted>
  <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>women Veterans</keyword>
  <keyword>interpersonal violence</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 12, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03261700/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03261700/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>RISE</title>
          <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
        </group>
        <group group_id="P2">
          <title>Enhanced Care as Usual Condition</title>
          <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29">1 participant did not attend either the 10 or 14 week follow-up assessment and thus is not included in primary intent-to-treat (ITT) analyses. The participant was not able to participate due to COVID-19 related stressors.</participants>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>The participant was not able to participate due to COVID-19 related stressors.</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>RISE</title>
          <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
        </group>
        <group group_id="B2">
          <title>Enhanced Care as Usual Condition</title>
          <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.7" spread="10.8"/>
                    <measurement group_id="B2" value="40.5" spread="13.0"/>
                    <measurement group_id="B3" value="39.1" spread="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="48"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sexual orientation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Heterosexual</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Lesbian/Gay</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Bisexual</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Pansexual</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Empowerment Via the Personal Progress Scale Revised</title>
        <description>Measures change in sense of personal empowerment; minimum value = 28 and maximum score = 196; higher scores indicate higher personal empowerment</description>
        <time_frame>Baseline,10-week follow-up, and 14-week follow-up assessments</time_frame>
        <population>Intent-to-treat (ITT) sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Empowerment Via the Personal Progress Scale Revised</title>
          <description>Measures change in sense of personal empowerment; minimum value = 28 and maximum score = 196; higher scores indicate higher personal empowerment</description>
          <population>Intent-to-treat (ITT) sample</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129.82" lower_limit="121.91" upper_limit="137.73"/>
                    <measurement group_id="O2" value="132.25" lower_limit="123.64" upper_limit="140.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146.13" lower_limit="137.80" upper_limit="154.46"/>
                    <measurement group_id="O2" value="137.24" lower_limit="129.85" upper_limit="144.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="148.07" lower_limit="139.62" upper_limit="156.52"/>
                    <measurement group_id="O2" value="137.66" lower_limit="130.15" upper_limit="145.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of groups on Empowerment via the Personal Progress Scale Revised</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.05</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Self-efficacy Via the General Self-Efficacy Scale</title>
        <description>This scale is a self-report of change in general self-efficacy; minimum score = 4 and maximum score = 40; higher scores indicate higher self-efficacy</description>
        <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
        <population>Intent-to-Treat (ITT) sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Self-efficacy Via the General Self-Efficacy Scale</title>
          <description>This scale is a self-report of change in general self-efficacy; minimum score = 4 and maximum score = 40; higher scores indicate higher self-efficacy</description>
          <population>Intent-to-Treat (ITT) sample</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.7" lower_limit="27.04" upper_limit="30.36"/>
                    <measurement group_id="O2" value="29.90" lower_limit="27.98" upper_limit="31.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.33" lower_limit="31.75" upper_limit="34.91"/>
                    <measurement group_id="O2" value="30.66" lower_limit="29.01" upper_limit="32.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.07" lower_limit="32.53" upper_limit="35.61"/>
                    <measurement group_id="O2" value="30.52" lower_limit="28.95" upper_limit="32.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of groups on self-efficacy via the General Self-Efficacy Scale</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.05</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Valued Living Questionnaire</title>
        <description>Measures change in valued living, and congruence between stated values and past-week valued behavior; Composite scores range from 10 (minimum) to 100 (maximum). Higher scores reflect higher valued living (i.e., an indicator of higher quality of life)</description>
        <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
        <population>Intent-to-Treat (ITT) sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Valued Living Questionnaire</title>
          <description>Measures change in valued living, and congruence between stated values and past-week valued behavior; Composite scores range from 10 (minimum) to 100 (maximum). Higher scores reflect higher valued living (i.e., an indicator of higher quality of life)</description>
          <population>Intent-to-Treat (ITT) sample</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.88" lower_limit="42.97" upper_limit="56.79"/>
                    <measurement group_id="O2" value="48.88" lower_limit="42.87" upper_limit="54.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.27" lower_limit="56.68" upper_limit="69.86"/>
                    <measurement group_id="O2" value="53.44" lower_limit="46.86" upper_limit="60.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.96" lower_limit="52.62" upper_limit="69.30"/>
                    <measurement group_id="O2" value="57.23" lower_limit="50.51" upper_limit="63.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Patient Activation Measure (PAM-13)</title>
        <description>Measures change in patient engagement in needed health care; scores are transferred to a theoretical 0-100 scale; higher scores indicate higher patient activation.</description>
        <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
        <population>Intent-to-Treat (ITT) Sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Activation Measure (PAM-13)</title>
          <description>Measures change in patient engagement in needed health care; scores are transferred to a theoretical 0-100 scale; higher scores indicate higher patient activation.</description>
          <population>Intent-to-Treat (ITT) Sample</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.89" lower_limit="59.19" upper_limit="72.58"/>
                    <measurement group_id="O2" value="64.62" lower_limit="58.64" upper_limit="70.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-week follow-up assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.5" lower_limit="69.49" upper_limit="83.51"/>
                    <measurement group_id="O2" value="69.24" lower_limit="64.30" upper_limit="74.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-week follow-up assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.5" lower_limit="67.87" upper_limit="83.13"/>
                    <measurement group_id="O2" value="70.12" lower_limit="65.50" upper_limit="74.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PTSD Checklist for DSM-5</title>
        <description>Measures change in DSM-5 PTSD symptom severity. Scores range from 0-80; higher scores reflect higher/worse PTSD symptoms.</description>
        <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
        <population>Intent-to-Treat (ITT) Sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veteran?s self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Information and Referral Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>PTSD Checklist for DSM-5</title>
          <description>Measures change in DSM-5 PTSD symptom severity. Scores range from 0-80; higher scores reflect higher/worse PTSD symptoms.</description>
          <population>Intent-to-Treat (ITT) Sample</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.92" lower_limit="35.98" upper_limit="47.85"/>
                    <measurement group_id="O2" value="39.97" lower_limit="34.20" upper_limit="45.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-week assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.97" lower_limit="22.69" upper_limit="36.72"/>
                    <measurement group_id="O2" value="36.97" lower_limit="31.25" upper_limit="42.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-week assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.73" lower_limit="25.11" upper_limit="40.35"/>
                    <measurement group_id="O2" value="32.13" lower_limit="25.61" upper_limit="38.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Center for Epidemiological Studies-Depression Scale</title>
        <description>Measures change in depressive symptoms; This measure ranges from 0-60; higher scores reflect (worse) higher levels of symptoms</description>
        <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
        <population>Intent-to-treat (ITT) sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Center for Epidemiological Studies-Depression Scale</title>
          <description>Measures change in depressive symptoms; This measure ranges from 0-60; higher scores reflect (worse) higher levels of symptoms</description>
          <population>Intent-to-treat (ITT) sample</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.21" lower_limit="23.38" upper_limit="31.04"/>
                    <measurement group_id="O2" value="24.50" lower_limit="20.29" upper_limit="28.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-week follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.59" lower_limit="14.84" upper_limit="24.34"/>
                    <measurement group_id="O2" value="22.76" lower_limit="19.36" upper_limit="26.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-week follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.12" lower_limit="15.77" upper_limit="26.47"/>
                    <measurement group_id="O2" value="19.72" lower_limit="15.32" upper_limit="24.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>SF-12 Health Survey</title>
        <description>Measures change in physical-health related quality of life. Specifically, quantitative ratings of overall physical health functioning were rated on a Likert scale of 1-5 (1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor).</description>
        <time_frame>Baseline, 10-Week follow-up, and 14-Week follow-up Assessments</time_frame>
        <population>Intent-to-treat (ITT) sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>SF-12 Health Survey</title>
          <description>Measures change in physical-health related quality of life. Specifically, quantitative ratings of overall physical health functioning were rated on a Likert scale of 1-5 (1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor).</description>
          <population>Intent-to-treat (ITT) sample</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread=".87"/>
                    <measurement group_id="O2" value="3" spread=".77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread=".87"/>
                    <measurement group_id="O2" value="2" spread=".74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" spread=".76"/>
                    <measurement group_id="O2" value="3" spread=".87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Conflict Tactic Scales Revised</title>
        <description>Measures change in overall number of different IPV acts over time (i.e., total count score). This measure ranges from 0-33; higher scores reflect higher levels of IPV (i.e., a worse outcome).</description>
        <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
        <population>ITT sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Conflict Tactic Scales Revised</title>
          <description>Measures change in overall number of different IPV acts over time (i.e., total count score). This measure ranges from 0-33; higher scores reflect higher levels of IPV (i.e., a worse outcome).</description>
          <population>ITT sample</population>
          <units>units on a scale (count scores)</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.17" lower_limit="8.15" upper_limit="14.2"/>
                    <measurement group_id="O2" value="11.67" lower_limit="9.14" upper_limit="14.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.37" lower_limit="2.20" upper_limit="4.54"/>
                    <measurement group_id="O2" value="4.93" lower_limit="2.56" upper_limit="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-Week Follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.34" lower_limit="1.17" upper_limit="5.51"/>
                    <measurement group_id="O2" value="2.8" lower_limit="1.76" upper_limit="3.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physical, Mental and Social Service Care Use</title>
        <description>Measures overall number of VA and non-VA health care visits (inclusive of physical, mental health, and social service use visits).</description>
        <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
        <population>Intent-to-treat (ITT) sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Physical, Mental and Social Service Care Use</title>
          <description>Measures overall number of VA and non-VA health care visits (inclusive of physical, mental health, and social service use visits).</description>
          <population>Intent-to-treat (ITT) sample</population>
          <units>visits</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.27" lower_limit="6.31" upper_limit="10.23"/>
                    <measurement group_id="O2" value="7.03" lower_limit="5.29" upper_limit="8.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.15" lower_limit="4.44" upper_limit="7.86"/>
                    <measurement group_id="O2" value="6.24" lower_limit="4.69" upper_limit="7.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.62" lower_limit="3.18" upper_limit="6.05"/>
                    <measurement group_id="O2" value="4.93" lower_limit="3.35" upper_limit="6.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Client Services Questionnaire (CSQ-8)</title>
        <description>Measures satisfaction with treatment; Scores range from 8 to 32; higher scores reflect higher satisfaction with treatment (i.e., a better outcome)</description>
        <time_frame>10-week follow-up assessment</time_frame>
        <population>Intent-to-Treat (ITT) Sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Client Services Questionnaire (CSQ-8)</title>
          <description>Measures satisfaction with treatment; Scores range from 8 to 32; higher scores reflect higher satisfaction with treatment (i.e., a better outcome)</description>
          <population>Intent-to-Treat (ITT) Sample</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.30" spread="2.78"/>
                    <measurement group_id="O2" value="25.07" spread="4.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Health Questionnaire</title>
        <description>Measures change in somatic and physical health symptoms; score ranges from 0 to 30, with higher scores representing higher levels of physical health problems</description>
        <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
        <population>Intent-to-treat (ITT) sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Health Questionnaire</title>
          <description>Measures change in somatic and physical health symptoms; score ranges from 0 to 30, with higher scores representing higher levels of physical health problems</description>
          <population>Intent-to-treat (ITT) sample</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.52" lower_limit="10.41" upper_limit="14.63"/>
                    <measurement group_id="O2" value="10.60" lower_limit="9.03" upper_limit="12.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.37" lower_limit="9.33" upper_limit="13.41"/>
                    <measurement group_id="O2" value="12.01" lower_limit="10.27" upper_limit="13.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.42" lower_limit="8.99" upper_limit="13.85"/>
                    <measurement group_id="O2" value="9.69" lower_limit="8.01" upper_limit="11.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety Behaviors Checklist</title>
        <description>Measures the present use of safety behaviors participants are currently using to protect themselves. Each of the 15 items of this measure corresponds to a specific safety behavior. Participant indicates whether they have used each behavior using a dichotomous response option (yes = 1; no = 0). Scores are summed, with total scores ranging from 0-15. Higher scores indicate a higher number of safety behaviors enacted.</description>
        <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
        <population>Intent-to-treat (ITT) sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Behaviors Checklist</title>
          <description>Measures the present use of safety behaviors participants are currently using to protect themselves. Each of the 15 items of this measure corresponds to a specific safety behavior. Participant indicates whether they have used each behavior using a dichotomous response option (yes = 1; no = 0). Scores are summed, with total scores ranging from 0-15. Higher scores indicate a higher number of safety behaviors enacted.</description>
          <population>Intent-to-treat (ITT) sample</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.87" lower_limit="11.97" upper_limit="13.77"/>
                    <measurement group_id="O2" value="12.94" lower_limit="12.09" upper_limit="13.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.04" lower_limit="11.59" upper_limit="14.49"/>
                    <measurement group_id="O2" value="12.39" lower_limit="10.79" upper_limit="13.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" lower_limit="6.85" upper_limit="11.95"/>
                    <measurement group_id="O2" value="12.34" lower_limit="10.75" upper_limit="13.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Connor-Davidson Resilience Scale</title>
        <description>Measures patient resilience; Scores range from 0-100,with higher scores reflecting higher resilience</description>
        <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
        <population>Intent-to-treat (ITT) sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Connor-Davidson Resilience Scale</title>
          <description>Measures patient resilience; Scores range from 0-100,with higher scores reflecting higher resilience</description>
          <population>Intent-to-treat (ITT) sample</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.43" lower_limit="23.28" upper_limit="27.59"/>
                    <measurement group_id="O2" value="24.1" lower_limit="21.87" upper_limit="26.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.67" lower_limit="27.24" upper_limit="32.09"/>
                    <measurement group_id="O2" value="26" lower_limit="23.9" upper_limit="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.65" lower_limit="26.9" upper_limit="32.41"/>
                    <measurement group_id="O2" value="26.07" lower_limit="23.8" upper_limit="28.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depression Anxiety Stress Scale- Anxiety Subscale</title>
        <description>Measures anxiety symptom severity; Scores range from 0-42, with higher scores indicating higher levels of anxiety.</description>
        <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
        <population>Intent-to-treat (ITT) sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Depression Anxiety Stress Scale- Anxiety Subscale</title>
          <description>Measures anxiety symptom severity; Scores range from 0-42, with higher scores indicating higher levels of anxiety.</description>
          <population>Intent-to-treat (ITT) sample</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.11" lower_limit="21.83" upper_limit="28.38"/>
                    <measurement group_id="O2" value="23.4" lower_limit="20.68" upper_limit="26.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.67" lower_limit="18.92" upper_limit="26.41"/>
                    <measurement group_id="O2" value="22.98" lower_limit="20.72" upper_limit="25.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.58" lower_limit="19.88" upper_limit="27.28"/>
                    <measurement group_id="O2" value="21.22" lower_limit="19.02" upper_limit="23.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Coping Strategies Inventory - Short Form</title>
        <description>Measures engagement coping skills; Scores range from 8-40, with higher score reflecting better coping</description>
        <time_frame>Baseline, 10-week follow-up, and 14-week follow-up assessments</time_frame>
        <population>Intent-to-treat (ITT) sample</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Enhanced Care as Usual Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Coping Strategies Inventory - Short Form</title>
          <description>Measures engagement coping skills; Scores range from 8-40, with higher score reflecting better coping</description>
          <population>Intent-to-treat (ITT) sample</population>
          <units>mean score on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.42" lower_limit="25.22" upper_limit="27.61"/>
                    <measurement group_id="O2" value="25.69" lower_limit="24.66" upper_limit="26.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.30" lower_limit="25.99" upper_limit="28.61"/>
                    <measurement group_id="O2" value="25.74" lower_limit="24.71" upper_limit="26.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>14-Week Follow-Up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.92" lower_limit="25.72" upper_limit="28.13"/>
                    <measurement group_id="O2" value="25.4" lower_limit="24.5" upper_limit="26.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.</title>
        <description>Semi-structured qualitative interview questions developed for the purpose of this study to assess participants' perceptions of the acceptability, with a particular item to assess overall helpfulness of the intervention. Specifically, quantitative ratings of overall helpfulness were rated on a Likert scale of 1-5 (1=highly helpful, 2 = somewhat helpful, 3 = neither helpful nor unhelpful, 4 = somewhat unhelpful, 5=highly unhelpful).</description>
        <time_frame>Assessed at 10-week follow-up or 14-week follow-up, values at the end of 14 weeks reported</time_frame>
        <population>Intent-to-Treat sample with completed helpfulness ratings at the 10- or 14-week follow-up assessments. From the RISE condition, 26 participants completed this assessment at the 10-week follow-up, and the remaining 3 completed it at the 14-week follow-up. From the Information and Referral condition, 29 participants completed this assessment at the 10-week follow-up and 1 participant completed it at the 14-week follow-up. Thus, the data represents summed count scores for each endorsed answer.</population>
        <group_list>
          <group group_id="O1">
            <title>RISE</title>
            <description>This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
          </group>
          <group group_id="O2">
            <title>Information and Referral Condition</title>
            <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.</title>
          <description>Semi-structured qualitative interview questions developed for the purpose of this study to assess participants' perceptions of the acceptability, with a particular item to assess overall helpfulness of the intervention. Specifically, quantitative ratings of overall helpfulness were rated on a Likert scale of 1-5 (1=highly helpful, 2 = somewhat helpful, 3 = neither helpful nor unhelpful, 4 = somewhat unhelpful, 5=highly unhelpful).</description>
          <population>Intent-to-Treat sample with completed helpfulness ratings at the 10- or 14-week follow-up assessments. From the RISE condition, 26 participants completed this assessment at the 10-week follow-up, and the remaining 3 completed it at the 14-week follow-up. From the Information and Referral condition, 29 participants completed this assessment at the 10-week follow-up and 1 participant completed it at the 14-week follow-up. Thus, the data represents summed count scores for each endorsed answer.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>'Highly helpful'</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>'Somewhat helpful'</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>'Neither helpful or unhelpful'</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>'Somewhat unhelpful'</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>'Highly unhelpful'</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>10-14 weeks following enrollment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>RISE</title>
          <description>This provider- administered brief- counseling intervention program will increase Women Veterans self- efficacy and personal empowerment in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for women veterans in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources and moving forward.&#xD;
RISE: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.</description>
        </group>
        <group group_id="E2">
          <title>Enhanced Care as Usual Condition</title>
          <description>This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.&#xD;
Information and referral condition: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>hospitalized for medical condition</sub_title>
                <description>Participants reported at the follow up assessment having been hospitalized for general medical conditions. These events were deemed by the IRB as not unexpected, not related to research participation, and involved no increased risk</description>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Katherine Iverson, PI</name_or_title>
      <organization>National Center for PTSD, located at the VA Boston Healthcare System</organization>
      <phone>857-364-2066</phone>
      <email>katherine.iverson@va.gov</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03261700
org study id: IIR 16-062
secondary id: 1I01HX002178-01A1
nct id: NCT03261700
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Intimate partner violence (IPV) is a major health concern for women Veterans. IPV is
      associated with numerous physical and mental health conditions. VHA is implementing IPV
      screening programs to identify female patients who experience past-year IPV. Despite strong
      evidence that screening increases detection of IPV, less is established about how to
      intervene following IPV disclosure in health care settings, in order to improve health
      outcomes. Existing healthcare-based interventions result in minimal effects on health and
      well-being, likely because they are too brief and generic.

      In response, the PI has developed Recovering from IPV through Strengths and Empowerment
      (RISE), based on the IPV-related health care needs and preferences of women Veterans. RISE is
      designed to be delivered in primary care and is an individualized, variable-length,
      modular-based intervention that addresses

        -  safety planning;

        -  education on the health effects of IPV and warning signs;

        -  increasing coping skills and self-care;

        -  enhancing social support;

        -  making difficult decisions; and

        -  connecting with resources. This study is aimed at refining and evaluating RISE for use
           with female VA patients who have experienced past-year IPV. This brief counseling
           intervention is intended to be administered in conjunction with primary care, as this is
           a frequent point of healthcare contact for women Veterans and where disclosure of IPV is
           most prevalent.
Women are the fastest growing group of VHA patients, with their population recently
      increasing by 80%. Women Veterans (WV's) are at higher risk for IPV than their non-Veteran
      peers, with that 1 in 3 WVs report lifetime IPV, compared to 1 in 4 women in the general U.S.
      population. Research reports up to 30% of WVs experience past-year IPV. As a result, WVs are
      considered an important population for IPV screening and counseling interventions. In
      response, VHA Women's Health Services (WHS) and the IPV Assistance Program of Care Management
      and Social Work Services (CMSWS) are implementing IPV screening programs for women and are
      seeking an effective intervention to implement into care. Extant brief counseling
      interventions for IPV result in minimal effects on patients' health and safety. A recent
      review of IPV screening trials highlighted insufficient intensity of post-disclosure
      counseling interventions, concluding that existing interventions are too brief, unstructured,
      and generic. Such minimal intervention effects of the current standard of care have led
      leaders in the field to call for the development and testing of new and more comprehensive
      IPV interventions, especially for delivery in conjunction with primary care. The Recovering
      from IPV through Strengths and Empowerment (RISE) intervention fills this need.

      The PI, a clinical psychologist and health services researcher with expertise in and national
      recognition for IPV research and care, has developed an innovative IPV intervention to
      respond to this need. Recovering from IPV through Strengths and Empowerment (RISE) is based
      on the healthcare needs and preferences of WVs who have experienced IPV. RISE was developed
      using rigorous methods, building on the evidence base from the applicant's HSR&D CDA and on
      input of VHA primary care and behavioral health experts. RISE is based on empowerment, a
      highly relevant intervention model for women who experience IPV. It is an individualized,
      variable-length, modular-based intervention addressing key factors:

        -  safety planning,

        -  educating about the health effects of IPV and warning signs,

        -  improving coping and self-care,

        -  enhancing social support,

        -  making difficult decisions, and

        -  connecting with resources. RISE is rooted in empowerment and incorporates aspects of
           Motivational Interviewing, an evidence-based approach designed to facilitate behavior
           change that is widely used in VHA for numerous health issues.

      This timely research project addresses the critical gap in current IPV care. It will refine
      and formally evaluate RISE using established methods for rapid and efficient effectiveness
      testing, including a Hybrid 1 randomized clinical trial (RCT) to evaluate RISE that
      simultaneously gathers information on barriers to and facilitators of implementation. The
      study is guided by the first two phases of the Replicating Effective Programs (REP)
      framework, pre-conditions and pre-implementation. These phases emphasize tailoring
      interventions with stakeholder input and iterative cycles of pilot testing within routine
      practice conditions. Use of the REP framework will maximize the likelihood that RISE-should
      its effectiveness be demonstrated-can easily be integrated into routine care in VHA.

      The Specific Aims of this study are as follows:

        1. Tailor and refine RISE to accommodate differences in service structures and personnel in
           different primary care settings through input from a Stakeholder Advisory Board, focus
           groups with WVs (four groups; n=24-32), and qualitative interviews with providers
           (n=24).

        2. Conduct a formative evaluation of RISE with WVs (n=up to 20) to inform the development
           of a user-friendly, tailored implementation protocol and intervention manual.

        3. Examine the effects of RISE on WVs' (n=60) individual psychosocial outcomes (e.g.,
           empowerment, self-efficacy, health symptoms, service use, and quality of life) in an RCT
           that compares RISE to an information/referral condition.

      3a. Evaluate the feasibility and acceptability of RISE in the context of the RCT.

      This study provides the groundwork to examine the effectiveness of RISE. The data will be
      used to demonstrate whether the effects of RISE appear promising to support a future-large
      scale effectiveness-implementation RCT, including the range of effect sizes that would be
      reasonable to expect in a future trial.

      The project was originally conducted at two Women's Health Practice-Based Research Network
      (PBRN) sites that have adopted IPV screening - the Women's Health Centers (WHC) at VA Boston
      Healthcare System and VA Connecticut Healthcare System. RCT study enrollment was discontinued
      at VA Connecticut in July 2019 due to low enrollment. The VA Boston Healthcare System serves
      as the sole site for data collection from July 2019 on and is the sourced of the RCT data.

      The COVID-19 pandemic resulted in modifications to IRB protocol to switch from in-person
      enrollment, assessments and sessions. There were several women actively involved in the trial
      during the initial shut-down. New recruitment and enrollment were temporarily hauled during
      early months of COVID-19, with virtual enrollment beginning as of July 2020.

      Recruitment and enrollment were completed in September 2020 because the enrollment goals were
      met and the planned sample size was obtained (N=60).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: For the RCT (Aim 3), participants will be randomized to RISE or an information and referral condition.
primary purpose: Treatment
masking: None (Open Label)
masking description: Open label
measure: Empowerment Via the Personal Progress Scale Revised
time frame: Baseline,10-week follow-up, and 14-week follow-up assessments
description: Measures change in sense of personal empowerment; minimum value = 28 and maximum score = 196; higher scores indicate higher personal empowerment
measure: Self-efficacy Via the General Self-Efficacy Scale
time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
description: This scale is a self-report of change in general self-efficacy; minimum score = 4 and maximum score = 40; higher scores indicate higher self-efficacy
measure: Valued Living Questionnaire
time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
description: Measures change in valued living, and congruence between stated values and past-week valued behavior; Composite scores range from 10 (minimum) to 100 (maximum). Higher scores reflect higher valued living (i.e., an indicator of higher quality of life)
measure: Patient Activation Measure (PAM-13)
time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
description: Measures change in patient engagement in needed health care; scores are transferred to a theoretical 0-100 scale; higher scores indicate higher patient activation.
measure: PTSD Checklist for DSM-5
time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
description: Measures change in DSM-5 PTSD symptom severity. Scores range from 0-80; higher scores reflect higher/worse PTSD symptoms.
measure: Center for Epidemiological Studies-Depression Scale
time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
description: Measures change in depressive symptoms; This measure ranges from 0-60; higher scores reflect (worse) higher levels of symptoms
measure: SF-12 Health Survey
time frame: Baseline, 10-Week follow-up, and 14-Week follow-up Assessments
description: Measures change in physical-health related quality of life. Specifically, quantitative ratings of overall physical health functioning were rated on a Likert scale of 1-5 (1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor).
measure: Conflict Tactic Scales Revised
time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
description: Measures change in overall number of different IPV acts over time (i.e., total count score). This measure ranges from 0-33; higher scores reflect higher levels of IPV (i.e., a worse outcome).
measure: Physical, Mental and Social Service Care Use
time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
description: Measures overall number of VA and non-VA health care visits (inclusive of physical, mental health, and social service use visits).
measure: Client Services Questionnaire (CSQ-8)
time frame: 10-week follow-up assessment
description: Measures satisfaction with treatment; Scores range from 8 to 32; higher scores reflect higher satisfaction with treatment (i.e., a better outcome)
measure: Patient Health Questionnaire
time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
description: Measures change in somatic and physical health symptoms; score ranges from 0 to 30, with higher scores representing higher levels of physical health problems
measure: Safety Behaviors Checklist
time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
description: Measures the present use of safety behaviors participants are currently using to protect themselves. Each of the 15 items of this measure corresponds to a specific safety behavior. Participant indicates whether they have used each behavior using a dichotomous response option (yes = 1; no = 0). Scores are summed, with total scores ranging from 0-15. Higher scores indicate a higher number of safety behaviors enacted.
measure: Connor-Davidson Resilience Scale
time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
description: Measures patient resilience; Scores range from 0-100,with higher scores reflecting higher resilience
measure: Depression Anxiety Stress Scale- Anxiety Subscale
time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
description: Measures anxiety symptom severity; Scores range from 0-42, with higher scores indicating higher levels of anxiety.
measure: Coping Strategies Inventory - Short Form
time frame: Baseline, 10-week follow-up, and 14-week follow-up assessments
description: Measures engagement coping skills; Scores range from 8-40, with higher score reflecting better coping
measure: Brief Semi-structured Interview to Assess Acceptability and Feasibility of the Intervention, With Perceived Helpfulness Rating.
time frame: Assessed at 10-week follow-up or 14-week follow-up, values at the end of 14 weeks reported
description: Semi-structured qualitative interview questions developed for the purpose of this study to assess participants' perceptions of the acceptability, with a particular item to assess overall helpfulness of the intervention. Specifically, quantitative ratings of overall helpfulness were rated on a Likert scale of 1-5 (1=highly helpful, 2 = somewhat helpful, 3 = neither helpful nor unhelpful, 4 = somewhat unhelpful, 5=highly unhelpful).
arm group label: RISE
arm group type: Experimental
description: This provider- administered brief- counseling intervention program will increase Women Veteran?s self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV, 3) improving coping and self- care and red flags, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
arm group label: Information and referral condition
arm group type: Active Comparator
description: This brochure-based intervention includes education about IPV, health effects of IPV, resources and referral options to address a wide-array of health and social issues associated with IPV, and safety planning. Participants randomized to this arm are offered resources and referrals to VA and community resources.
intervention type: Behavioral
intervention name: RISE
description: This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
arm group label: RISE
other name: Recovering from IPV through Strengths and Empowerment
intervention type: Other
intervention name: Information and referral condition
description: Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
arm group label: Information and referral condition
other name: Control condition
criteria: 
gender: Female
gender based: Yes
gender description: Self-identify as female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katherine M. Iverson, PhD MA BA
role: Principal Investigator
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
facility: 
country: United States
citation: Dardis CM, Dichter ME, Iverson KM. Empowerment, PTSD and revictimization among women who have experienced intimate partner violence. Psychiatry Res. 2018 Aug;266:103-110. doi: 10.1016/j.psychres.2018.05.034. Epub 2018 May 30.
PMID: 29859496
citation: Grillo AR, Danitz SB, Dichter ME, Driscoll MA, Gerber MR, Hamilton AB, Wiltsey-Stirman S, Iverson KM. Strides Toward Recovery From Intimate Partner Violence: Elucidating Patient-Centered Outcomes to Optimize a Brief Counseling Intervention for Women. J Interpers Violence. 2021 Aug;36(15-16):NP8431-NP8453. doi: 10.1177/0886260519840408. Epub 2019 Apr 17.
PMID: 30994401
citation: Iverson KM, Dardis CM, Grillo AR, Galovski TE, Pogoda TK. Associations between traumatic brain injury from intimate partner violence and future psychosocial health risks in women. Compr Psychiatry. 2019 Jul;92:13-21. doi: 10.1016/j.comppsych.2019.05.001. Epub 2019 May 14.
PMID: 31203176
citation: Danitz SB, Stirman SW, Grillo AR, Dichter ME, Driscoll M, Gerber MR, Gregor K, Hamilton AB, Iverson KM. When user-centered design meets implementation science: integrating provider perspectives in the development of an intimate partner violence intervention for women treated in the United States' largest integrated healthcare system. BMC Womens Health. 2019 Nov 27;19(1):145. doi: 10.1186/s12905-019-0837-8.
PMID: 31771557
citation: Iverson KM, Danitz SB, Driscoll M, Vogt D, Hamilton AB, Gerber MR, Wiltsey Stirman S, Shayani DR, Suvak MK, Dichter ME. Recovering from intimate partner violence through Strengths and Empowerment (RISE): Development, pilot testing, and refinement of a patient-centered brief counseling intervention for women. Psychol Serv. 2022;19(Suppl 2):102-112. doi: 10.1037/ser0000544. Epub 2021 Jun 10.
PMID: 34110870
citation: Iverson KM, Danitz SB, Shayani DR, Vogt D, Stirman SW, Hamilton AB, Mahoney CT, Gerber MR, Dichter ME. Recovering From Intimate Partner Violence Through Strengths and Empowerment: Findings From a Randomized Clinical Trial. J Clin Psychiatry. 2021 Nov 23;83(1):21m14041. doi: 10.4088/JCP.21m14041.
PMID: 34813687
citation: Shayani DR, Danitz SB, Low SK, Hamilton AB, Iverson KM. Women Tell All: A Comparative Thematic Analysis of Women's Perspectives on Two Brief Counseling Interventions for Intimate Partner Violence. Int J Environ Res Public Health. 2022 Feb 22;19(5):2513. doi: 10.3390/ijerph19052513.
PMID: 35270204
citation: Davin KR, Dardis CM, Barth MR, Iverson KM. Prospective mental health effects of intimate partner stalking among women veterans. Psychol Trauma. 2022 Jul;14(5):751-758. doi: 10.1037/tra0001144. Epub 2021 Nov 4.
PMID: 34735188
citation: Iverson KM, Dardis CM, Cowlishaw S, Webermann AR, Shayani DR, Dichter ME, Mitchell KS, Mattocks KM, Gerber MR, Portnoy GR. Effects of Intimate Partner Violence During COVID-19 and Pandemic-Related Stress on the Mental and Physical Health of Women Veterans. J Gen Intern Med. 2022 Sep;37(Suppl 3):724-733. doi: 10.1007/s11606-022-07589-z. Epub 2022 Aug 30.
PMID: 36042090
citation: Webermann AR, Dardis CM, Iverson KM. The role of general self-efficacy in intimate partner violence and symptoms of posttraumatic stress disorder among women veterans. J Trauma Stress. 2022 Jun;35(3):868-878. doi: 10.1002/jts.22794. Epub 2022 Jan 31.
PMID: 35099821
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 