Relationship Checkups to Reduce Veteran Suicide Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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BACKGROUND: Romantic relationship distress is a common area of concern for Veterans struggling with depression, posttraumatic stress disorder (PTSD), alcohol misuse, and suicide ideation. In a study of Veterans who screened positive for the above concerns in primary care, 58% of partnered Veterans reported romantic relationship problems. Relationship problems are also a prominent risk factor for suicide, preceding 24% of Veteran suicide deaths and 50% for Veterans 18-35. Conversely, full participation in mutually supportive relationships confers protection against suicide. This suggests it may be able to offset risk by turning distressed relationships into protective partnerships. Unfortunately, the intensive formats of existing couple therapies result in couples discontinuing after 2-3 sessions or delaying treatment until they are close to breakup. This underscores the need for brief relationship support that is accessible through primary care mental health (PC-MHI).

Relationship Checkup programs incorporates a combination of couple therapy and motivational interviewing techniques to encourage couples to make concrete commitments to improve their relationship. The Brief Relationship Checkup (BRC) is a three 30-minute session version initially designed to address relationship distress in primary care. BRC demonstrates efficacy in reducing suicide risk factors such as relationship dysfunction and depressed mood while promoting protective factors such as mutual responsiveness to one another's concerns, a core element of supportive relationships. Earlier Checkup programs have also been shown to increase individual and couple therapy engagement. In an open label pilot trial, the investigators found BRC was feasible and acceptable to Veterans screening positive on VA PC-MHI screens. The investigators also found its highly structured framework could be learned by trainees without prior couple therapy experience.

RESEARCH PLAN: This study is a randomized controlled trial (RCT) of BRC administered to evaluate its ability to modify suicide risk/protective factors. Up to 360 participants will be enrolled and screened by phone to identify couples that are in distressed committed relationship where at least one partner is a Veteran who screens positive on a PC-MHI screen for common suicide risk factors including suicide ideation, depression, PTSD, or alcohol misuse (the "Screened Veteran"). The target is to randomize 72 couples (144 individuals) to BRC or to three sessions of the current PC-MHI Co-Located Collaborative Care model (CCC) for the Screened Veteran only. All participants will complete baseline, post-treatment, 3-month, and 6-month assessments.

SPECIFIC AIMS: The study will provide the foundations for a larger clinical trial proposal through pursuit of the following research aims and hypotheses (H):

AIM 1: Determine BRC's efficacy in improving relationship factors related to suicide for both partners.

AIM 2: Determine BRC's efficacy in improving individual factors related to suicide for the Screened Veteran.

AIM 3: Develop and validate a fidelity codebook to operationalize BRC adherence and clinician competency.

Conditions

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Relationship Distress Mental Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The interviewer who evaluates clinical outcomes will not know the assigned condition of the participants.

Study Groups

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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.

Group Type EXPERIMENTAL

Brief Relationship Checkup (BRC)

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

Co-Located Collaborative Care (CCC)

Intervention Type 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)

Interventions

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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.

Intervention Type BEHAVIORAL

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)

Intervention Type BEHAVIORAL

Other Intervention Names

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Marriage Checkup; Relationship Checkup Behavioral Health Consultation

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No