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Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT05525676

Conditions

Relationship Distress

Mental Health

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brief Relationship Checkup (BRC)

Co-Located Collaborative Care (CCC)

Study Details

Brief summary:

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.

Conditions

Relationship Distress

Mental Health

Study ID

NCT05525676

Start date

Jan 3, 2023

Status verified date

Aug, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. BOTH PARTNERS must be age 18 or over
2. BOTH PARTNERS must demonstrate sufficient knowledge of English and cognitive capacity to understand the study through comprehension of consent questions
3. BOTH PARTNERS must self-identify as "in a committed relationship" with their partner for at least 6-months.
4. AT LEAST ONE PARTNER must report at least mild relationship distress on a relationship satisfaction screen (CSI-4).
5. AT LEAST ONE PARTNER must be a VHA-enrolled Veteran who screens positive on a VA Primary Care Mental Health Screen for ONE OR MORE of the following conditions: Depressed Mood, Unsafe drinking, Posttraumatic stress, or Suicidal Ideation.

Exclusion Criteria:

1. EITHER PARTNER reports that they are already engaged in ongoing couple or family therapy.
2. EITHER PARTNER reports severe intimate partner violence in the last year.
3. EITHER PARTNER reports ongoing or upcoming legal conflicts between one another (e.g., custody dispute; restraining order; divorce proceedings)
4. EITHER PARTNER reports experiencing suicidal intent requiring hospitalization.
5. EITHER PARTNER experiences past-month psychosis or mania.
6. EITHER PARTNER has completed therapy with the PI, Dr. Dev Crasta, within the last 5 years.

Study Design

Enrollment

245 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Brief Relationship Checkup (BRC)

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)

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)

Primary outcome measure

  • Relationship Functioning [ Time Frame: Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization) ]
  • Relationship Functioning [ Time Frame: Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization) ]

Central Contacts and Locations

More Information

Sponsor

VA Office of Research and Development

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • Randomized Controlled Trial
  • Couple therapy
  • Primary Care
  • Partner Communication

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-08-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.