xml: <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/NCT06011161</url>
    </required_header>
    <id_info>
      <org_study_id>1469686</org_study_id>
      <nct_id>NCT06011161</nct_id>
    </id_info>
    <brief_title>A Pilot of the Brief Relationship Checkup</brief_title>
    <acronym>BRC</acronym>
    <official_title>The Brief Relationship Checkup: A 3-Session Program to Support Veteran Relationships</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Canandaigua VA Medical Center</agency>
        <agency_class>U.S. Fed</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>US Department of Veterans Affairs</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>Canandaigua VA Medical Center</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this pilot trial is to study the Brief Relationship Checkup (BRC) program for&#xD;
        Veterans with a combination of mental health and relationship concerns.&#xD;
  &#xD;
        BRC has been studied in Air Force primary care, but has never been tested in the Department&#xD;
        of Veterans Affairs. To prepare for a larger study of BRC, the investigators asked the&#xD;
        following questions:&#xD;
  &#xD;
          1. Can the research team deliver BRC to Veterans with mental health concerns?&#xD;
             (&quot;Feasibility&quot;)&#xD;
  &#xD;
          2. What is the best way to measure BRC's impact? (&quot;Pilot Outcomes&quot;)&#xD;
  &#xD;
          3. Does BRC fit the needs of Veterans, and if not, what changes would fit participants'&#xD;
             needs? (&quot;Refinement&quot;)&#xD;
  &#xD;
        Participants completed an initial interview, attended the BRC program, and completed a&#xD;
        follow-up interview.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PURPOSE: Relationship distress is a common problem for Veterans with mental health concerns.&#xD;
        Relationship treatments like couple therapy are effective, but studies in the Department of&#xD;
        Veterans Affairs (VA) find that they are infrequently used and have high dropout rates. One&#xD;
        possible solution is for VA to offer Relationship Checkups, a short program that helps&#xD;
        couples commit to concrete steps to improve their relationship. A brief version of the&#xD;
        program designed for Air Force primary care -- called the Brief Relationship Checkup (BRC)&#xD;
        for the purpose of the study -- may be an especially good fit for VA primary care or&#xD;
        outpatient mental health teams.&#xD;
  &#xD;
        RESEARCH PLAN: This study is a single-arm pilot trial of BRC in 20 couples. that are in&#xD;
        distressed committed relationship where at least one partner is a Veteran who screens&#xD;
        positive on a primary care mental health screen for common suicide risk factors including&#xD;
        suicide ideation, depression, PTSD, or alcohol misuse (the &quot;Identified Patient&quot;).&#xD;
        Participants provided initial ratings of outcomes in separate baseline sessions, completed&#xD;
        BRC, and then completed separate post-treatment interviews and questionnaires.&#xD;
  &#xD;
        SPECIFIC AIMS:&#xD;
  &#xD;
        AIM 1: Evaluate feasibility of conducting a BRC trial in Veterans with mental health&#xD;
        concerns. This includes recruitment rate, completion rate, and provider adherence to&#xD;
        protocol.&#xD;
  &#xD;
        AIM 2: Pilot outcomes that can be used to evaluate pre-post change in future studies of BRC.&#xD;
        This includes relationship functioning, suicide risk factors, and treatment utilization.&#xD;
  &#xD;
        AIM 3: Inform continued refinement of BRC to be suitable to the needs of Veterans and their&#xD;
        partners. This includes examining current acceptability and using open-ended interviews.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 28, 2020</start_date>
    <completion_date type="Actual">July 20, 2021</completion_date>
    <primary_completion_date type="Actual">July 20, 2021</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Single arm pilot. All participants will participate in the same treatment.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Relationship Functioning</measure>
      <time_frame>Pre-treatment</time_frame>
      <description>Relationship Functioning will be measured using the Couples Satisfaction Index (CSI). The self-report scale has a minimum of 0 and a maximum of 161 with higher scores representing more satisfying relationships and scores &lt; 104.5 classified as &quot;distressed.&quot; The CSI is widely used in couple therapy research and is used routinely in VA care to evaluate Veterans' progress in evidence-based couple therapies.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Relationship Functioning</measure>
      <time_frame>After Completing the BRC Program (1-3months after pre-treatment)</time_frame>
      <description>Relationship Functioning will be measured using the Couples Satisfaction Index (CSI). The self-report scale has a minimum of 0 and a maximum of 161 with higher scores representing more satisfying relationships and scores &lt; 104.5 classified as &quot;distressed.&quot; The CSI is widely used in couple therapy research and is used routinely in VA care to evaluate Veterans' progress in evidence-based couple therapies.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Emotional Intimacy/Mutual Responsiveness</measure>
      <time_frame>Pre-treatment</time_frame>
      <description>Emotional Intimacy will be measured using the Perceived Responsiveness &amp; Insensitivity Scale (PRI). The PRI has a minimum of 0 and a maximum of 80. The PRI is an optimized measure of &quot;Perceived Partner Responsiveness,&quot; a model of emotional intimacy that is widely used in the field to understand whether partners see one another as understanding/caring.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emotional Intimacy/Mutual Responsiveness</measure>
      <time_frame>After Completing the BRC Program (1-3months after pre-treatment)</time_frame>
      <description>Emotional Intimacy will be measured using the Perceived Responsiveness &amp; Insensitivity Scale (PRI). The PRI has a minimum of 0 and a maximum of 80. The PRI is an optimized measure of &quot;Perceived Partner Responsiveness,&quot; a model of emotional intimacy that is widely used in the field to understand whether partners see one another as understanding/caring.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depressive Symptoms</measure>
      <time_frame>Pre-treatment</time_frame>
      <description>Depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). This self-report scale has a minimum of 0 and a maximum of 27 with higher scores representing greater number and frequency of depression symptoms and scores of 10 or higher representing moderate depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depressive Symptoms</measure>
      <time_frame>After Completing the BRC Program (1-3months after pre-treatment)</time_frame>
      <description>Depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). This self-report scale has a minimum of 0 and a maximum of 27 with higher scores representing greater number and frequency of depression symptoms and scores of 10 or higher representing moderate depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Burdensomeness</measure>
      <time_frame>Pre-treatment</time_frame>
      <description>Perceived burdensomeness will be measured with the burden-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 6 and a maximum of 42 with higher scores representing a stronger belief that one is a burden on others. Scores of 12 or higher predict a higher risk for developing suicidal ideation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Perceived Burdensomeness</measure>
      <time_frame>After Completing the BRC Program (1-3months after pre-treatment)</time_frame>
      <description>Perceived burdensomeness will be measured with the burden-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 6 and a maximum of 42 with higher scores representing a stronger belief that one is a burden on others. Scores of 12 or higher predict a higher risk for developing suicidal ideation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Thwarted Belongingness</measure>
      <time_frame>Pre-treatment</time_frame>
      <description>Thwarted belongingness will be measured with the belonging-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 9 and a maximum of 63 with higher scores representing a stronger feeling of loneliness and isolation. Scores of 36 or higher predict a higher risk for developing suicidal ideation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Thwarted Belongingness</measure>
      <time_frame>After Completing the BRC Program (1-3months after pre-treatment)</time_frame>
      <description>Thwarted belongingness will be measured with the belonging-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 9 and a maximum of 63 with higher scores representing a stronger feeling of loneliness and isolation. Scores of 36 or higher predict a higher risk for developing suicidal ideation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Suicide Ideation Severity</measure>
      <time_frame>Pre-treatment</time_frame>
      <description>Suicide ideation over the study will be monitored using the &quot;Last Month&quot; version of the Columbia Suicide Severity Rating Scale (CSSRS). This semi-structured interview has interviewers rate suicide ideation on a scale of 0 to 5, with scores of 3-5 placing individuals at high risk for attempt. VA hospitals use the C-SSRS across all clinics.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Suicide Ideation Severity</measure>
      <time_frame>After Completing the BRC Program (1-3months after pre-treatment)</time_frame>
      <description>Suicide ideation over the study will be monitored using the &quot;Last Month&quot; version of the Columbia Suicide Severity Rating Scale (CSSRS). This semi-structured interview has interviewers rate suicide ideation on a scale of 0 to 5, with scores of 3-5 placing individuals at high risk for attempt. VA hospitals use the C-SSRS across all clinics.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Number of Mental Health and Family Contacts</measure>
      <time_frame>90 day period before treatment</time_frame>
      <description>Treatment engagement in mental health services will be assessed through a review of the electronic medical record. Staff will review appointments (e.g., individual, group, assessments) with a specific focus on general mental health services and couple/family support services (including Caregiver Support program and Intimate Partner Violence Assistance Program).</description>
    </other_outcome>
    <other_outcome>
      <measure>Number of Mental Health and Family Contacts</measure>
      <time_frame>90 day period after treatment</time_frame>
      <description>Treatment engagement in mental health services will be assessed through a review of the electronic medical record. Staff will review appointments (e.g., individual, group, assessments) with a specific focus on general mental health services and couple/family support services (including Caregiver Support program and Intimate Partner Violence Assistance Program).</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Relationship Distress</condition>
    <arm_group>
      <arm_group_label>Brief Relationship Checkup</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Couples in the experimental condition will participate in three joint sessions of the Brief Relationship Checkup (BRC; Cordova 2014; Cigrang et al., 2016). This program has been tested in Air Force Primary Care but we do not know if veterans with mental health concerns will be able to attend it (feasibility), complete it safely (tolerability), and enjoy it (acceptability).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Brief Relationship Checkup (BRC)</intervention_name>
      <description>The investigators are using the three 30-minute session protocol developed for Air Force Primary Care (Cigrang et al., 2016). Although it is simply referred to as the &quot;Marriage Checkup&quot; in that manuscript, the investigators use the name BRC to distinguish it from many other versions of Dr. James Cordova's Marriage Checkup (Cordova, 2014) adapted for different settings. Sessions in this version are briefer than other versions (30 mins vs. 60-90 mins) and this trial does not have any eligibility restrictions based on marital status.</description>
      <arm_group_label>Brief Relationship Checkup</arm_group_label>
      <other_name>Marriage Checkup</other_name>
      <other_name>Relationship Checkup</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. BOTH PARTNERS must be age 18 or over&#xD;
  &#xD;
            2. BOTH PARTNERS must demonstrate sufficient knowledge of English and cognitive capacity&#xD;
               to understand the study through comprehension of consent questions&#xD;
  &#xD;
            3. BOTH PARTNERS must self-identify as &quot;in a committed relationship&quot; with their partner&#xD;
               for at least 6-months.&#xD;
  &#xD;
            4. AT LEAST ONE PARTNER must report at least mild relationship distress on a satisfaction&#xD;
               screen.&#xD;
  &#xD;
            5. AT LEAST ONE PARTNER must have Veteran status&#xD;
  &#xD;
            6. THE VETERAN PARTNER must screen positive on at least on a VA Primary Care Mental&#xD;
               Health Screen (i.e., PHQ-2 for Depression, PHQ Item 9 for Suicide Risk; AUDIT&#xD;
               Consumption Questions for At-Risk Drinking; or PC-PTSD-5 for Potential PTSD)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. EITHER PARTNER reports that they are engaged in ongoing couple or family therapy.&#xD;
  &#xD;
            2. EITHER PARTNER reports severe intimate partner violence in the last year.&#xD;
  &#xD;
            3. EITHER PARTNER reports experiencing suicidal intent or suicidal attempts in the last&#xD;
               month.&#xD;
  &#xD;
            4. EITHER PARTNER experiences current psychosis.&#xD;
  &#xD;
            5. EITHER PARTNER experiences current mania.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Finger Lakes Healthcare System (Canandaigua)</name>
        <address>
          <city>Canandaigua</city>
          <state>New York</state>
          <zip>14424</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Canandaigua VA Medical Center</investigator_affiliation>
      <investigator_full_name>Dev J. Crasta</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Couple therapy</keyword>
    <keyword>Primary Care</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>We will create deidentified datasets containing only variables used in a publication. This will be limited to the quantitative variables underlying publication to minimize likelihood of reidentification.&#xD;
  Deidentified datasets will be stored in repositories if required for publication. Otherwise, they will be available on request to individual researchers with appropriate credentials.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>Data will be available beginning one year after publication.</ipd_time_frame>
      <ipd_access_criteria>Researchers must demonstrate they are accessing the data for validation of results or other scientific/public purposes (e.g., replication of findings, incorporation of findings in meta-analyses).&#xD;
  Data sets will not be shared prior to the facility Privacy Officer approval of the access request and deidentification steps.</ipd_access_criteria>
    </patient_data>
    <provided_document_section>
      <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>March 27, 2020</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT06011161/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011161
  org study id: 1469686
  nct id: NCT06011161
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this pilot trial is to study the Brief Relationship Checkup (BRC) program for
        Veterans with a combination of mental health and relationship concerns.
  
        BRC has been studied in Air Force primary care, but has never been tested in the Department
        of Veterans Affairs. To prepare for a larger study of BRC, the investigators asked the
        following questions:
  
          1. Can the research team deliver BRC to Veterans with mental health concerns?
             ("Feasibility")
  
          2. What is the best way to measure BRC's impact? ("Pilot Outcomes")
  
          3. Does BRC fit the needs of Veterans, and if not, what changes would fit participants'
             needs? ("Refinement")
  
        Participants completed an initial interview, attended the BRC program, and completed a
        follow-up interview.
  PURPOSE: Relationship distress is a common problem for Veterans with mental health concerns.
        Relationship treatments like couple therapy are effective, but studies in the Department of
        Veterans Affairs (VA) find that they are infrequently used and have high dropout rates. One
        possible solution is for VA to offer Relationship Checkups, a short program that helps
        couples commit to concrete steps to improve their relationship. A brief version of the
        program designed for Air Force primary care -- called the Brief Relationship Checkup (BRC)
        for the purpose of the study -- may be an especially good fit for VA primary care or
        outpatient mental health teams.
  
        RESEARCH PLAN: This study is a single-arm pilot trial of BRC in 20 couples. that are in
        distressed committed relationship where at least one partner is a Veteran who screens
        positive on a primary care mental health screen for common suicide risk factors including
        suicide ideation, depression, PTSD, or alcohol misuse (the "Identified Patient").
        Participants provided initial ratings of outcomes in separate baseline sessions, completed
        BRC, and then completed separate post-treatment interviews and questionnaires.
  
        SPECIFIC AIMS:
  
        AIM 1: Evaluate feasibility of conducting a BRC trial in Veterans with mental health
        concerns. This includes recruitment rate, completion rate, and provider adherence to
        protocol.
  
        AIM 2: Pilot outcomes that can be used to evaluate pre-post change in future studies of BRC.
        This includes relationship functioning, suicide risk factors, and treatment utilization.
  
        AIM 3: Inform continued refinement of BRC to be suitable to the needs of Veterans and their
        partners. This includes examining current acceptability and using open-ended interviews.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Single arm pilot. All participants will participate in the same treatment.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Relationship Functioning
  time frame: Pre-treatment
  description: Relationship Functioning will be measured using the Couples Satisfaction Index (CSI). The self-report scale has a minimum of 0 and a maximum of 161 with higher scores representing more satisfying relationships and scores < 104.5 classified as "distressed." The CSI is widely used in couple therapy research and is used routinely in VA care to evaluate Veterans' progress in evidence-based couple therapies.
  measure: Relationship Functioning
  time frame: After Completing the BRC Program (1-3months after pre-treatment)
  description: Relationship Functioning will be measured using the Couples Satisfaction Index (CSI). The self-report scale has a minimum of 0 and a maximum of 161 with higher scores representing more satisfying relationships and scores < 104.5 classified as "distressed." The CSI is widely used in couple therapy research and is used routinely in VA care to evaluate Veterans' progress in evidence-based couple therapies.
  measure: Emotional Intimacy/Mutual Responsiveness
  time frame: Pre-treatment
  description: Emotional Intimacy will be measured using the Perceived Responsiveness & Insensitivity Scale (PRI). The PRI has a minimum of 0 and a maximum of 80. The PRI is an optimized measure of "Perceived Partner Responsiveness," a model of emotional intimacy that is widely used in the field to understand whether partners see one another as understanding/caring.
  measure: Emotional Intimacy/Mutual Responsiveness
  time frame: After Completing the BRC Program (1-3months after pre-treatment)
  description: Emotional Intimacy will be measured using the Perceived Responsiveness & Insensitivity Scale (PRI). The PRI has a minimum of 0 and a maximum of 80. The PRI is an optimized measure of "Perceived Partner Responsiveness," a model of emotional intimacy that is widely used in the field to understand whether partners see one another as understanding/caring.
  measure: Depressive Symptoms
  time frame: Pre-treatment
  description: Depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). This self-report scale has a minimum of 0 and a maximum of 27 with higher scores representing greater number and frequency of depression symptoms and scores of 10 or higher representing moderate depression.
  measure: Depressive Symptoms
  time frame: After Completing the BRC Program (1-3months after pre-treatment)
  description: Depression will be measured using the 9-item Patient Health Questionnaire (PHQ-9). This self-report scale has a minimum of 0 and a maximum of 27 with higher scores representing greater number and frequency of depression symptoms and scores of 10 or higher representing moderate depression.
  measure: Perceived Burdensomeness
  time frame: Pre-treatment
  description: Perceived burdensomeness will be measured with the burden-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 6 and a maximum of 42 with higher scores representing a stronger belief that one is a burden on others. Scores of 12 or higher predict a higher risk for developing suicidal ideation.
  measure: Perceived Burdensomeness
  time frame: After Completing the BRC Program (1-3months after pre-treatment)
  description: Perceived burdensomeness will be measured with the burden-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 6 and a maximum of 42 with higher scores representing a stronger belief that one is a burden on others. Scores of 12 or higher predict a higher risk for developing suicidal ideation.
  measure: Thwarted Belongingness
  time frame: Pre-treatment
  description: Thwarted belongingness will be measured with the belonging-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 9 and a maximum of 63 with higher scores representing a stronger feeling of loneliness and isolation. Scores of 36 or higher predict a higher risk for developing suicidal ideation.
  measure: Thwarted Belongingness
  time frame: After Completing the BRC Program (1-3months after pre-treatment)
  description: Thwarted belongingness will be measured with the belonging-specific subscale of the Interpersonal Needs Questionnaire (INQ). This self-report scale has a minimum of 9 and a maximum of 63 with higher scores representing a stronger feeling of loneliness and isolation. Scores of 36 or higher predict a higher risk for developing suicidal ideation.
  measure: Suicide Ideation Severity
  time frame: Pre-treatment
  description: Suicide ideation over the study will be monitored using the "Last Month" version of the Columbia Suicide Severity Rating Scale (CSSRS). This semi-structured interview has interviewers rate suicide ideation on a scale of 0 to 5, with scores of 3-5 placing individuals at high risk for attempt. VA hospitals use the C-SSRS across all clinics.
  measure: Suicide Ideation Severity
  time frame: After Completing the BRC Program (1-3months after pre-treatment)
  description: Suicide ideation over the study will be monitored using the "Last Month" version of the Columbia Suicide Severity Rating Scale (CSSRS). This semi-structured interview has interviewers rate suicide ideation on a scale of 0 to 5, with scores of 3-5 placing individuals at high risk for attempt. VA hospitals use the C-SSRS across all clinics.
  measure: Number of Mental Health and Family Contacts
  time frame: 90 day period before treatment
  description: Treatment engagement in mental health services will be assessed through a review of the electronic medical record. Staff will review appointments (e.g., individual, group, assessments) with a specific focus on general mental health services and couple/family support services (including Caregiver Support program and Intimate Partner Violence Assistance Program).
  measure: Number of Mental Health and Family Contacts
  time frame: 90 day period after treatment
  description: Treatment engagement in mental health services will be assessed through a review of the electronic medical record. Staff will review appointments (e.g., individual, group, assessments) with a specific focus on general mental health services and couple/family support services (including Caregiver Support program and Intimate Partner Violence Assistance Program).
  arm group label: Brief Relationship Checkup
  arm group type: Experimental
  description: Couples in the experimental condition will participate in three joint sessions of the Brief Relationship Checkup (BRC; Cordova 2014; Cigrang et al., 2016). This program has been tested in Air Force Primary Care but we do not know if veterans with mental health concerns will be able to attend it (feasibility), complete it safely (tolerability), and enjoy it (acceptability).
  intervention type: Behavioral
  intervention name: Brief Relationship Checkup (BRC)
  description: The investigators are using the three 30-minute session protocol developed for Air Force Primary Care (Cigrang et al., 2016). Although it is simply referred to as the "Marriage Checkup" in that manuscript, the investigators use the name BRC to distinguish it from many other versions of Dr. James Cordova's Marriage Checkup (Cordova, 2014) adapted for different settings. Sessions in this version are briefer than other versions (30 mins vs. 60-90 mins) and this trial does not have any eligibility restrictions based on marital status.
  arm group label: Brief Relationship Checkup
  other name: Marriage Checkup
  other name: Relationship Checkup
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Canandaigua VA Medical Center
  investigator full name: Dev J. Crasta
  investigator title: Principal Investigator
  sharing ipd: Yes
  ipd description: We will create deidentified datasets containing only variables used in a publication. This will be limited to the quantitative variables underlying publication to minimize likelihood of reidentification.
  Deidentified datasets will be stored in repositories if required for publication. Otherwise, they will be available on request to individual researchers with appropriate credentials.
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Analytic Code
  ipd time frame: Data will be available beginning one year after publication.
  ipd access criteria: Researchers must demonstrate they are accessing the data for validation of results or other scientific/public purposes (e.g., replication of findings, incorporation of findings in meta-analyses).
  Data sets will not be shared prior to the facility Privacy Officer approval of the access request and deidentification steps.
  provided document: 