Clinical trial NCT05525676: Relationship Checkups to Reduce Veteran Suicide Risk
Official title: Supporting Relationships to Reduce Suicide Risk: A Randomized Control Trial of the Brief Relationship Checkup
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Relationship Distress
Mental Health
Keywords: Randomized Controlled Trial
Couple therapy
Primary Care
Partner Communication
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-09-01
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Relationship Functioning
timeFrame: Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)
measure: Relationship Functioning
timeFrame: Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization)
Secondary outcomes:
measure: Emotional Intimacy/Mutual Responsiveness
timeFrame: Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)
measure: Emotional Intimacy/Mutual Responsiveness
timeFrame: Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization)
measure: Treatment Engagement in Mental Health Services
timeFrame: 180 day period after Post-Treatment session (1.5 months after randomization)
Other outcomes:
measure: Depressive Symptoms
timeFrame: Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)
measure: Posttraumatic Stress Disorder (PTSD) Symptom Severity
timeFrame: Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)
measure: Depressive Symptoms
timeFrame: Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization)
measure: Posttraumatic Stress Disorder (PTSD) Symptom Severity
timeFrame: Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization)
measure: Alcohol Use
timeFrame: Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)
measure: Alcohol Use
timeFrame: Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization)
measure: Suicide Ideation Severity
timeFrame: Change from Baseline (First Assessment) to Post-Treatment (approx. 1.5 months after randomization)
measure: Suicide Ideation Severity
timeFrame: Monthly Change over 6 Months Post-Treatment (approx. 1.5 months to 7.5 months after randomization)
Locations:
city: Canandaigua
country: United States
facility: VA Finger Lakes Healthcare System, Canandaigua, NY
state: New York
Study officials:
affiliation: VA Finger Lakes Healthcare System, Canandaigua, NY
name: Dev J Crasta
role: PRINCIPAL_INVESTIGATOR
References: