Relationship Checkups to Reduce Veteran Suicide Risk

NCT05525676 | Recruiting DMC

• 2 other identifiers: D3823-WIK2RX003823
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (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). Treatment efficacy is defined as the gains in satisfaction being significantly greater in one arm than the other (p\<.05).

  Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)

• 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).

  Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization)

Secondary Outcomes (3)

• Emotional Intimacy/Mutual Responsiveness

  Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)

• Emotional Intimacy/Mutual Responsiveness

  Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization)

• Treatment Engagement in Mental Health Services

  180 day period after Post-Treatment session (1.5 months after randomization)

Other Outcomes (8)

• Depressive Symptoms

  Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)

• Posttraumatic Stress Disorder (PTSD) Symptom Severity

  Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)

• Depressive Symptoms

  Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization)

Study Arms (2)

Brief Relationship Checkup (BRC)

EXPERIMENTAL

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.

Behavioral: Brief Relationship Checkup (BRC)

Co-Located Collaborative Care (CCC)

ACTIVE COMPARATOR

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.

Behavioral: Co-Located Collaborative Care (CCC)

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.

Also known as: Marriage Checkup; Relationship Checkup

Brief Relationship Checkup (BRC)

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)

Also known as: Behavioral Health Consultation

Co-Located Collaborative Care (CCC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• EITHER PARTNER experiences past-month psychosis or mania.
• EITHER PARTNER has completed therapy with the PI, Dr. Dev Crasta, within the last 5 years.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Finger Lakes Healthcare System, Canandaigua, NY

Canandaigua, New York, 14424-1159, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Dev J Crasta

  VA Finger Lakes Healthcare System, Canandaigua, NY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jovana Demonjic, MPH

CONTACT

(423) 609-2113; Jovana.Demonjic@va.gov

Dev J Crasta

CONTACT

(585) 393-7537; dev.crasta@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The interviewer who evaluates clinical outcomes will not know the assigned condition of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial design. Participants in both arms will receive active treatments that are matched for length (three, 30-minute sessions) over a 45 day period. After that couples will be assessed for 6 months.

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 1, 2022
• Study Start: January 3, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)