Relationship Checkups to Reduce Veteran Suicide Risk

Part of paid clinical trials in Canandaigua, New York.

Sponsor
VA Office of Research and Development
Study ID
NCT05525676
Status
Recruiting
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Conditions

  • Mental Health
  • Relationship Distress

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Brief Relationship Checkup (BRC) — BEHAVIORAL
    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.
  • Co-Located Collaborative Care (CCC) — BEHAVIORAL
    The 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)

Study Details

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.

Key Dates

Start date
Jan 3, 2023
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brief Relationship Checkup (BRC)
    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 has not been explored in Veterans with ongoing mental health issues and has not been compared to an active treatment.
  • Active Comparator: Co-Located Collaborative Care (CCC)
    The comparison condition will be three sessions of Co-Located Collaborative Care (CCC) offered to the Screened Veteran only. This reflects the current standard of care in VA Primary Care Mental Health.

Primary Outcome Measure

Relationship Functioning [ Time Frame: Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Finger Lakes Healthcare System, Canandaigua, NYCanandaiguaNew York14424-1159
Jovana Demonjic, MPH
[email protected]
423-609-2113
Dev J Crasta
[email protected]
(585) 393-7537
Dev J Crasta (PRINCIPAL_INVESTIGATOR)

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