<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/NCT03256227</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 15-322</org_study_id>
    <nct_id>NCT03256227</nct_id>
  </id_info>
  <brief_title>Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families</brief_title>
  <official_title>Improving Veteran Adherence to Treatment for PTSD Through Partnering With Families</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Evidence-based psychotherapies (EBP) for PTSD, such as Prolonged Exposure (PE), result in&#xD;
      clinically significant symptom relief for many. Yet, adherence to this treatment (i.e.,&#xD;
      session attendance and homework compliance), which is vital to ensuring recovery, can be&#xD;
      poor. This project will test the effectiveness of improving family support for PE as a tool&#xD;
      to improve Veterans' PE adherence. Reducing rates of dropout from PE will positively impact&#xD;
      Veterans' health and well-being and lower the cost of treating PTSD. Additionally, despite&#xD;
      congressional legislation and national mandates within VA/DoD for family involvement in PTSD&#xD;
      care, there remains no proven strategies for how to routinely include family in traditional&#xD;
      individual (i.e., one-on-one) EBPs for PTSD. This proposal will provide the initial test of a&#xD;
      model of family engagement that can be translated to other problems faced by Veterans,&#xD;
      including suicide prevention, traumatic brain injury (TBI) rehabilitation, and pain&#xD;
      management, contributing to a broader evolution towards evidence-based, family-inclusive&#xD;
      care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Impacts. This study aims to improve Veterans' adherence to evidence-based treatment for PTSD,&#xD;
      through increasing family support for treatment. Improving retention rates in evidence-based&#xD;
      PTSD treatment will positively impact Veterans' health and well-being, lower the cost of&#xD;
      treating PTSD, and decrease long-term demand for PTSD services. If effective, this approach&#xD;
      could help resolve national calls for routine inclusion of family involvement in PTSD&#xD;
      treatment. Once demonstrated for PTSD, these strategies could be utilized for other&#xD;
      conditions and problems relevant to Veteran populations (e.g., suicide prevention, traumatic&#xD;
      brain injury (TBI) rehabilitation) and stimulate shifts across practice and policy to better&#xD;
      routine and evidence-based involvement of families in care.&#xD;
&#xD;
      Background. PTSD occurs in as many as 1 in 5 combat Veterans and is associated with a host of&#xD;
      negative, long-term consequences to the individual, their families, and society at large.&#xD;
      Evidence-based psychotherapies, such as Prolonged Exposure (PE), result in clinically&#xD;
      significant symptom relief for many. Yet, adherence to these treatments (i.e., session&#xD;
      attendance and homework compliance), which is vital to ensuring recovery, can be poor.&#xD;
      Engaging families in Veterans' treatment may provide a powerful method for promoting EBP&#xD;
      adherence. The investigators data indicate that 70% of Veterans express some interest in&#xD;
      involving their family in their care for PTSD; yet, only 17% of providers have had any&#xD;
      contact with Veterans' families. The objective of the proposed study is to evaluate the&#xD;
      effectiveness of improving family support as a tool to improve Veterans' EBP adherence. This&#xD;
      research agenda directly addresses two VA HSR&amp;D priorities:&#xD;
&#xD;
        -  innovative mental health care;&#xD;
&#xD;
        -  improving the quality of life for Veterans and their caregivers. The work aligns with&#xD;
           the VHA Blueprint for Excellence and Strategic Plan through meeting the unique needs of&#xD;
           military-service disabled Veterans, providing a novel treatment approach, and&#xD;
           emphasizing patient- and family-centered care.&#xD;
&#xD;
      Objectives/Aims. Aim 1: To improve Veterans' adherence to PE through engaging families in&#xD;
      care.&#xD;
&#xD;
      H1: Veterans randomized to family supported PE will attend more sessions (H1a) and report&#xD;
      greater homework compliance (H1b) than Veterans randomized to standard PE delivered in&#xD;
      routine care.&#xD;
&#xD;
      Aim 2: To improve the clinical outcomes of Veterans receiving PE through engaging families in&#xD;
      care.&#xD;
&#xD;
      H2: Family supported PE will be more effective than standard PE in reducing PTSD severity and&#xD;
      comorbid problems (depression, quality of life, relationship functioning) from baseline to&#xD;
      posttreatment.&#xD;
&#xD;
      Aim 3: To examine barriers/facilitators of implementing family support for PE. Exploratory&#xD;
      Aim: To identify mechanisms underlying adherence differences between treatment conditions.&#xD;
&#xD;
      The investigators will explore if adherence differences are mediated by changes on key social&#xD;
      influence variables (family perceptions of treatment credibility, family support for PE, and&#xD;
      family symptom accommodation).&#xD;
&#xD;
      Methods. The investigators are proposing a practical randomized controlled trial to compare&#xD;
      Veteran adherence, and to PE with and without family attendance at PE's educational sessions,&#xD;
      with the ultimate goal to improve Veterans' clinical outcomes. For Aim 3, the investigators&#xD;
      will use a concurrent process evaluation to identify potential implementation facilitators&#xD;
      and barriers to family involvement in PE within VA. Participants will include Veterans with&#xD;
      clinically significant symptoms of PTSD across three sites, plus a family member or friend of&#xD;
      the Veteran. Aim 1 outcome variables include session attendance and homework compliance. Aim&#xD;
      2 outcomes include PTSD symptom severity, depression, quality of life, and relationship&#xD;
      functioning, measured monthly over the course of treatment. Key social influences&#xD;
      (Exploratory Aim) will be assessed through brief weekly self-reports.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2018</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</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>effectiveness-implementation Hybrid 1, 2-arm, pragmatic randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Assessors are blinded to treatment condition</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>session attendance</measure>
    <time_frame>16 weeks</time_frame>
    <description>Number of treatment sessions attended by the participant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PTSD Checklist for DSM-5 (PCL-5)</measure>
    <time_frame>16 weeks</time_frame>
    <description>The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">256</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Family Supported Prolonged Exposure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Prolonged Exposure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard Prolonged Exposure for PTSD as delivered in routine VA care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Family Supported Prolonged Exposure</intervention_name>
    <description>The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.</description>
    <arm_group_label>Family Supported Prolonged Exposure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Prolonged Exposure</intervention_name>
    <description>Standard Prolonged Exposure for PTSD as delivered in routine VA care.</description>
    <arm_group_label>Standard Prolonged Exposure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female veterans at least 18 years old. Recruitment is limited to Veterans&#xD;
             enrolled in VHA care.&#xD;
&#xD;
          2. Participant meets DSM-5 diagnostic criteria for PTSD or subthreshold PTSD. Consistent&#xD;
             with recommendations, subthreshold PTSD will be defined as endorsement of criteria A&#xD;
             (trauma), F (duration), and G (impairment), with at least one symptom from each of the&#xD;
             remaining diagnostic criteria (Brancu et al., 2016).&#xD;
&#xD;
          3. Has an intimate partner, family member, or friend with whom they have contact with at&#xD;
             least 3 times a week&#xD;
&#xD;
          4. Willing to allow this person to participate in the study.&#xD;
&#xD;
          5. Provides informed consent.&#xD;
&#xD;
          6. Speaks and reads English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current suicidal or homicidal ideation with intent and/or plan.&#xD;
&#xD;
          2. Meets DSM-5 criteria for a manic of psychotic episode in the past 3 months.&#xD;
&#xD;
          3. Meets DSM-5 diagnostic criteria for a severe substance use disorder in the past 3&#xD;
             months. Of note, subjects can be abusing or dependent upon nicotine or marijuana and&#xD;
             still be included in the study.&#xD;
&#xD;
          4. Moderate relationship violence between the identified support person and the Veteran,&#xD;
             defined as one or more episodes of severe violence in the past year (e.g., punched,&#xD;
             kicked, or beat up).&#xD;
&#xD;
          5. Support person screens positive for PTSD on a self-report instrument (PCL).&#xD;
&#xD;
          6. Having an ongoing medical condition that would interfere with ability to attend weekly&#xD;
             treatment sessions.&#xD;
&#xD;
          7. Having any planned upcoming major medical procedures over the next several months that&#xD;
             would interfere with ability to attend weekly treatment sessions.&#xD;
&#xD;
          8. Veteran and/or SP fails to complete baseline survey&#xD;
&#xD;
          9. Episode of mania/psychosis in past 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura A. Meis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Minneapolis VA Health Care System, Minneapolis, MN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Atlanta VA Medical and Rehab Center, Decatur, GA</name>
      <address>
        <city>Decatur</city>
        <state>Georgia</state>
        <zip>30033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Ann Arbor Healthcare System, Ann Arbor, MI</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minneapolis VA Health Care System, Minneapolis, MN</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Meis LA, Glynn SM, Spoont MR, Kehle-Forbes SM, Nelson D, Isenhart CE, Eftekhari A, Ackland PE, Linden EB, Orazem RJ, Cutting A, Hagel Campbell EM, Astin MC, Porter KE, Smith E, Chuick CD, Lamp KE, Vuper TC, Oakley TA, Khan LB, Keckeisen SK, Polusny MA. Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement. Trials. 2022 Mar 30;23(1):243. doi: 10.1186/s13063-022-06183-2.</citation>
    <PMID>35354481</PMID>
  </results_reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>July 18, 2022</last_update_submitted>
  <last_update_submitted_qc>July 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Posttraumatic Stress Disorder</keyword>
  <keyword>family therapy</keyword>
  <keyword>patient adherence</keyword>
  <keyword>Prolonged Exposure Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>May 9, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03256227
org study id: IIR 15-322
nct id: NCT03256227
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Evidence-based psychotherapies (EBP) for PTSD, such as Prolonged Exposure (PE), result in
      clinically significant symptom relief for many. Yet, adherence to this treatment (i.e.,
      session attendance and homework compliance), which is vital to ensuring recovery, can be
      poor. This project will test the effectiveness of improving family support for PE as a tool
      to improve Veterans' PE adherence. Reducing rates of dropout from PE will positively impact
      Veterans' health and well-being and lower the cost of treating PTSD. Additionally, despite
      congressional legislation and national mandates within VA/DoD for family involvement in PTSD
      care, there remains no proven strategies for how to routinely include family in traditional
      individual (i.e., one-on-one) EBPs for PTSD. This proposal will provide the initial test of a
      model of family engagement that can be translated to other problems faced by Veterans,
      including suicide prevention, traumatic brain injury (TBI) rehabilitation, and pain
      management, contributing to a broader evolution towards evidence-based, family-inclusive
      care.
Impacts. This study aims to improve Veterans' adherence to evidence-based treatment for PTSD,
      through increasing family support for treatment. Improving retention rates in evidence-based
      PTSD treatment will positively impact Veterans' health and well-being, lower the cost of
      treating PTSD, and decrease long-term demand for PTSD services. If effective, this approach
      could help resolve national calls for routine inclusion of family involvement in PTSD
      treatment. Once demonstrated for PTSD, these strategies could be utilized for other
      conditions and problems relevant to Veteran populations (e.g., suicide prevention, traumatic
      brain injury (TBI) rehabilitation) and stimulate shifts across practice and policy to better
      routine and evidence-based involvement of families in care.

      Background. PTSD occurs in as many as 1 in 5 combat Veterans and is associated with a host of
      negative, long-term consequences to the individual, their families, and society at large.
      Evidence-based psychotherapies, such as Prolonged Exposure (PE), result in clinically
      significant symptom relief for many. Yet, adherence to these treatments (i.e., session
      attendance and homework compliance), which is vital to ensuring recovery, can be poor.
      Engaging families in Veterans' treatment may provide a powerful method for promoting EBP
      adherence. The investigators data indicate that 70% of Veterans express some interest in
      involving their family in their care for PTSD; yet, only 17% of providers have had any
      contact with Veterans' families. The objective of the proposed study is to evaluate the
      effectiveness of improving family support as a tool to improve Veterans' EBP adherence. This
      research agenda directly addresses two VA HSR&D priorities:

        -  innovative mental health care;

        -  improving the quality of life for Veterans and their caregivers. The work aligns with
           the VHA Blueprint for Excellence and Strategic Plan through meeting the unique needs of
           military-service disabled Veterans, providing a novel treatment approach, and
           emphasizing patient- and family-centered care.

      Objectives/Aims. Aim 1: To improve Veterans' adherence to PE through engaging families in
      care.

      H1: Veterans randomized to family supported PE will attend more sessions (H1a) and report
      greater homework compliance (H1b) than Veterans randomized to standard PE delivered in
      routine care.

      Aim 2: To improve the clinical outcomes of Veterans receiving PE through engaging families in
      care.

      H2: Family supported PE will be more effective than standard PE in reducing PTSD severity and
      comorbid problems (depression, quality of life, relationship functioning) from baseline to
      posttreatment.

      Aim 3: To examine barriers/facilitators of implementing family support for PE. Exploratory
      Aim: To identify mechanisms underlying adherence differences between treatment conditions.

      The investigators will explore if adherence differences are mediated by changes on key social
      influence variables (family perceptions of treatment credibility, family support for PE, and
      family symptom accommodation).

      Methods. The investigators are proposing a practical randomized controlled trial to compare
      Veteran adherence, and to PE with and without family attendance at PE's educational sessions,
      with the ultimate goal to improve Veterans' clinical outcomes. For Aim 3, the investigators
      will use a concurrent process evaluation to identify potential implementation facilitators
      and barriers to family involvement in PE within VA. Participants will include Veterans with
      clinically significant symptoms of PTSD across three sites, plus a family member or friend of
      the Veteran. Aim 1 outcome variables include session attendance and homework compliance. Aim
      2 outcomes include PTSD symptom severity, depression, quality of life, and relationship
      functioning, measured monthly over the course of treatment. Key social influences
      (Exploratory Aim) will be assessed through brief weekly self-reports.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: effectiveness-implementation Hybrid 1, 2-arm, pragmatic randomized controlled trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Assessors are blinded to treatment condition
measure: session attendance
time frame: 16 weeks
description: Number of treatment sessions attended by the participant
measure: PTSD Checklist for DSM-5 (PCL-5)
time frame: 16 weeks
description: The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
arm group label: Family Supported Prolonged Exposure
arm group type: Experimental
description: The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.
arm group label: Standard Prolonged Exposure
arm group type: Active Comparator
description: Standard Prolonged Exposure for PTSD as delivered in routine VA care.
intervention type: Behavioral
intervention name: Family Supported Prolonged Exposure
description: The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.
arm group label: Family Supported Prolonged Exposure
intervention type: Behavioral
intervention name: Standard Prolonged Exposure
description: Standard Prolonged Exposure for PTSD as delivered in routine VA care.
arm group label: Standard Prolonged Exposure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laura A. Meis, PhD
role: Principal Investigator
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
facility: 
facility: 
facility: 
country: United States
citation: Meis LA, Glynn SM, Spoont MR, Kehle-Forbes SM, Nelson D, Isenhart CE, Eftekhari A, Ackland PE, Linden EB, Orazem RJ, Cutting A, Hagel Campbell EM, Astin MC, Porter KE, Smith E, Chuick CD, Lamp KE, Vuper TC, Oakley TA, Khan LB, Keckeisen SK, Polusny MA. Can families help veterans get more from PTSD treatment? A randomized clinical trial examining Prolonged Exposure with and without family involvement. Trials. 2022 Mar 30;23(1):243. doi: 10.1186/s13063-022-06183-2.
PMID: 35354481
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No
submitted: May 9, 2023