Relationship Checkups to Reduce Veteran Suicide Risk
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
This study compares two approaches to working with Veterans that have a mix of mental health and relationship concerns in primary care. One approach is a 3-session couple-based program called the Brief Relationship Checkup (BRC). BRC has shown promise improving relationship health in Air Force primary care (including some mental health symptoms related to relationship functioning) but has never been tested for individuals with significant mental health concerns. The other approach is a high-quality delivery of three sessions of Co-Located Collaborative Care (CCC) with the Screened Veteran only. This program is the current standard of care for Veterans reporting mental health concerns in primary care (including mental health concerns related to their relationship) but has never been tested for individuals struggling with relationship concerns. The goal is to compare the benefits of the couples-based program vs. the individual-based program when it comes to reducing suicide risk factors at the relationship level and the individual level.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
BOTH PARTNERS must be age 18 or over
BOTH PARTNERS must demonstrate sufficient knowledge of English and cognitive capacity to understand the study through comprehension of consent questions
BOTH PARTNERS must self-identify as "in a committed relationship" with their partner for at least 6-months.
AT LEAST ONE PARTNER must report at least mild relationship distress on a relationship satisfaction screen (CSI-4).
Disqualifiers
EITHER PARTNER reports that they are already engaged in ongoing couple or family therapy.
EITHER PARTNER reports severe intimate partner violence in the last year.
EITHER PARTNER reports ongoing or upcoming legal conflicts between one another (e.g., custody dispute; restraining order; divorce proceedings)
EITHER PARTNER reports experiencing suicidal intent requiring hospitalization.
Trial design
Design model
Parallel
Treatments tested in this trial
Brief Relationship Checkup (BRC)
BehavioralThe 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.
Co-Located Collaborative Care (CCC)
BehavioralThe investigators are using the Co-Located Collaborative Care model developed by the VA Center for Integrated Healthcare to deliver at all VAs. Although the CCC model is flexible and can range from 1-6 sessions, in this study the investigators standardize the model to three sessions for a clear comparison with BRC. Session 1 uses the CCC "Functional Assessment"/"Initial Assessment" protocol. Sessions 2 \& 3 use the CCC Follow-up protocol. Session 1 (25-30 min)- Veteran completes a functional assessment of concerns (15 mins) and then develops a personalized action plan (10 minutes) Session 2 (25-30 min)- Veteran's progress addressing concerns is assessed (5 mins) and the remainder of the session is spend updating the action plan (20 minutes) Session 3 (25-30 min)- Veteran's progress addressing concerns is assessed (5 mins) and the remainder of the session is spend updating the action plan, including receiving referrals (20 minutes)
Treatment groups
360 Participants
are divided into 2 treatment groupsGroup A: Brief Relationship Checkup (BRC)Experimental treatment 1 intervention
Group B: Co-Located Collaborative Care (CCC)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Relationship Functioning
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. Analyses will compare relationship functioning across both Screened Veterans and their Partners using 3-level multilevel models with waves of assessment (Level 1) nested within individual partners (Level 2) nested within couples (Level 3). Treatment efficacy is defined as the gains in satisfaction being significantly greater in one arm than the other (p\<.05).
Time frame
Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)2
Relationship Functioning
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. Analyses will compare relationship functioning across both Screened Veterans and their Partners using 3-level multilevel models with waves of assessment (Level 1) nested within individual partners (Level 2) nested within couples (Level 3).
Time frame
Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization)Secondary outcomes
1
Emotional Intimacy/Mutual Responsiveness
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. Analyses will compare responsiveness across both Screened Veterans and their Partners using 3-level multilevel models with waves of assessment (Level 1) nested within individual partners (Level 2) nested within couples (Level 3). Treatment efficacy is defined as the gains in intimacy being significantly greater in one arm than the other (p\<.05).
Time frame
Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)2
Emotional Intimacy/Mutual Responsiveness
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. Analyses will compare responsiveness across both Screened Veterans and their Partners using 3-level multilevel models with waves of assessment (Level 1) nested within individual partners (Level 2) nested within couples (Level 3).
Time frame
Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization)3
Treatment Engagement in Mental Health Services
Treatment engagement in mental health services will be assessed through a review of the electronic medical record over each of the following windows: 1) 180-day period prior to baseline session; 2) during the treatment period from baseline to post-treatment, 3) the 180-day period after the post-treatment assessment. Over each window, staff will review appointments (e.g., individual, group, assessments), consults placed (e.g., General Mental Health; MST coordinator); and new prescriptions. Analyses will compare treatment engagement using 2-level multilevel models with assessment periods (Level 1) nested within Screened Veterans (Level 2). Their partners may or may not have VA electronic medical records, but available partner data will be used as a covariate. Treatment efficacy is defined as the Screened Veterans' treatment engagement being significantly greater in one arm than the other after accounting for treatment utilization prior to baseline (p\<.05).
Time frame
180 day period after Post-Treatment session (1.5 months after randomization)Other outcomes
1
Depressive Symptoms
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. Exploratory analyses will calculate 95% confidence intervals to compare Screened Veteran trajectories across the two study arms.
Time frame
Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)2
Posttraumatic Stress Disorder (PTSD) Symptom Severity
Posttraumatic symptom will be measured using the Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5). This self-report scale has a minimum of 0 and a maximum of 80 with higher scores representing more extreme symptoms and scores of 33 or higher representing probable PTSD. The PCL-5 is used routinely in VA care to evaluate Veterans' progress in long-term PTSD treatment. Exploratory analyses will calculate 95% confidence intervals to compare Screened Veteran trajectories across the two study arms.
Time frame
Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)3
Depressive Symptoms
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. Exploratory analyses will calculate 95% confidence intervals to compare Screened Veteran trajectories across the two study arms.
Time frame
Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization)4
Posttraumatic Stress Disorder (PTSD) Symptom Severity
Posttraumatic symptom will be measured using the Posttraumatic Stress Disorder Checklist for the DSM-5 (PCL-5). This self-report scale has a minimum of 0 and a maximum of 80 with higher scores representing more extreme symptoms and scores of 33 or higher representing probable PTSD. The PCL-5 is used routinely in VA care to evaluate Veterans' progress in long-term PTSD treatment. Exploratory analyses will calculate 95% confidence intervals to compare Screened Veteran trajectories across the two study arms.
Time frame
Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization)Sponsors and contacts
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Source ClinicalTrials.gov