Couples-Based Therapy for Reducing Veteran Suicide Risk

(BRC RCT Trial)

Recruiting at 1 trial location

Overseen By Jovana Demonjic, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Couple therapy, Severe violence, Legal conflicts, Suicidal hospitalization, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1.5 months

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two therapy approaches for Veterans with mental health issues and relationship concerns. One option, the Brief Relationship Checkup (BRC), involves couples participating together. The other, Co-Located Collaborative Care (CCC), focuses on the individual Veteran. The researchers aim to determine which method more effectively reduces suicide risk by improving mental health and relationship quality. Veterans enrolled in VA healthcare, who face mental health challenges like depression or PTSD and are in a committed relationship experiencing distress, might be a good fit. As an unphased trial, this study offers Veterans a unique opportunity to explore innovative therapy options that could enhance their mental health and relationship quality.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Brief Relationship Checkup (BRC) is safe and well-received by participants. Studies have found that this three-session program is effective and suitable for veterans facing mental health challenges. Testing with Air Force members demonstrated improvements in relationship health and mental well-being.

Although specific safety data for veterans with severe mental health issues is lacking, current evidence suggests that BRC is a promising option without major safety concerns. Participants have not reported any serious negative side effects, indicating the program's safety in similar situations.

For the Co-Located Collaborative Care (CCC), the standard approach in VA primary care, specific safety data is not available here. However, it is widely used for mental health issues and is considered a reliable method, supporting its safety for people dealing with similar challenges. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a fresh approach to reducing veteran suicide risk by focusing on relationships. The Brief Relationship Checkup (BRC) is unique as it involves couples in therapy sessions, emphasizing the importance of relationship dynamics in mental health. Unlike standard care, which typically targets the individual veteran, BRC seeks to enhance the veteran's support system by working with their partner, potentially leading to more robust and lasting mental health improvements. Meanwhile, the Co-Located Collaborative Care (CCC) provides a streamlined, integrated care experience that reflects current VA practices, but the addition of the BRC could introduce a new dimension of support that hasn't been widely explored in veterans.

What evidence suggests that this trial's treatments could be effective for reducing veteran suicide risk?

Studies have shown that the Brief Relationship Checkup (BRC), one of the treatments in this trial, can improve relationship health and related mental health symptoms. Tested in Air Force primary care settings, it shows promise for addressing mental health issues linked to relationships. For veterans with mental health concerns, early findings suggest BRC is safe, acceptable, and may help reduce factors that increase suicide risk. Although it hasn't been directly tested on individuals with severe mental health challenges, its focus on improving relationships could be beneficial. Co-Located Collaborative Care (CCC), the other treatment arm in this trial, serves as the current standard for veterans with mental health concerns, but it hasn't been tested for those with relationship issues. Both BRC and CCC aim to enhance mental health and relationship health, each offering unique strengths based on previous research. ^{1 2 3 6 7}

Who Is on the Research Team?

Dev J Crasta

Principal Investigator

VA Finger Lakes Healthcare System, Canandaigua, NY

Are You a Good Fit for This Trial?

This trial is for couples where at least one partner is a Veteran enrolled in the VHA, experiencing mild relationship distress and mental health concerns like depression or PTSD. Both must be over 18, have been in a committed relationship for at least six months, speak English well enough to understand the study, and not be hospitalized for suicidal intent or engaged in ongoing couple therapy.

Inclusion Criteria

Both my partner and I understand English well and can comprehend study details.

My partner and I have been in a committed relationship for at least 6 months.

AT LEAST ONE PARTNER must report at least mild relationship distress on a relationship satisfaction screen (CSI-4)

Exclusion Criteria

EITHER PARTNER reports experiencing suicidal intent requiring hospitalization

My partner or I are currently in couple or family therapy.

My partner or I have experienced severe intimate partner violence in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Brief Relationship Checkup (BRC) or Co-Located Collaborative Care (CCC) over three sessions

1.5 months

3 sessions

Post-Treatment Assessment

Participants complete assessments to evaluate changes in relationship and individual factors related to suicide risk

1.5 months

Follow-up

Participants are monitored for changes in PTSD, depressive symptoms, alcohol use, and suicide ideation

6 months

Monthly assessments

What Are the Treatments Tested in This Trial?

Interventions

• Brief Relationship Checkup (BRC)
• Co-Located Collaborative Care (CCC)

Trial Overview

The study compares two programs: Brief Relationship Checkup (BRC), a three-session couple-based program aimed at improving relationship health; and Co-Located Collaborative Care (CCC), an individual-based standard care with three sessions focusing on mental health issues related to relationships.

How Is the Trial Designed?

Group I: Brief Relationship Checkup (BRC) Experimental Treatment 1 Intervention

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 II: Co-Located Collaborative Care (CCC) Active Control 1 Intervention

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.

Brief Relationship Checkup (BRC) is already approved in United States for the following indications:

Approved in United States as Brief Relationship Checkup for:

• Reducing suicide risk factors in veterans with mental health and relationship concerns

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Implementation facilitation in mental health teams significantly improved team processes and clarity of roles, with notable increases in team development measures, indicating that structured support can enhance collaborative care models in real-world settings.

While overall self-reported health status showed little improvement, veterans with multiple mental health diagnoses experienced significant health status gains, and there was a marked reduction in hospitalization rates during the facilitation period, suggesting targeted benefits for complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Implementing a Collaborative Chronic Care Model for Clinician Teams on Patient Outcomes and Health Status in Mental Health: A Randomized Clinical Trial. Bauer, MS., Miller, CJ., Kim, B., et al.[2020]

A novel randomized controlled trial is investigating the efficacy of an abbreviated 8-session version of cognitive-behavioral conjoint therapy (B-CBCT) for veterans with PTSD and their partners, aiming to improve both PTSD symptoms and relationship functioning.

The study compares B-CBCT delivered through clinical videoteleconferencing (CVT) at home versus traditional in-person sessions, potentially increasing access to care for veterans who prefer remote treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a randomized superiority trial of a brief couple treatment for PTSD. Morland, LA., Macdonald, A., Grubbs, KM., et al.[2023]

Behavioral health providers (BHPs) in the VA's co-located, collaborative care (CCC) model play a crucial role in delivering integrated mental health services to Veterans, but face various system and clinic-level challenges that impact their effectiveness.

The study highlights the need for additional support for BHPs to enhance their ability to provide patient-centered care and improve healthcare integration within the VA system, based on insights from interviews with 14 BHPs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral health providers' perspectives of delivering behavioral health services in primary care: a qualitative analysis. Beehler, GP., Wray, LO.[2021]

Collaborative care (CC) has proven effective in enhancing behavioral health services for adults, and there is growing evidence that it can also benefit children and adolescents, particularly in school settings.

Adapting the CC model for schools could significantly improve access to behavioral health services, enhance the capacity of schools to deliver these services, and increase the effectiveness of interventions through evidence-based practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Care to Improve Access and Quality in School-Based Behavioral Health. Lyon, AR., Whitaker, K., Richardson, LP., et al.[2020]

The 3-session Relationship Checkup (RC) program for veterans with mental health and relationship issues was found to be feasible and safe, with a 90% treatment completion rate and no reported suicidal behaviors or physical harm during sessions.

Participants reported significant improvements in relationship functioning, emotional intimacy, and various mental health indicators, suggesting that the RC could be a promising approach to reduce suicide risk factors in couples at elevated risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief relationship support as a selective suicide prevention intervention: Piloting the Relationship Checkup in veteran couples with relationship and mental health concerns. Crasta, D., Funderburk, JS., Gray, TD., et al.[2023]

In a study of 174 couples, 36.43% of Veteran couples dropped out during the assessment phase of therapy, with non-Veteran partners' severe depressive symptoms being a key predictor of dropout.

Relationship satisfaction improved significantly during the assessment phase for couples who remained, particularly benefiting non-Veteran partners, suggesting that the assessment itself may serve as a valuable intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Couple Therapy with Veterans: Early Improvements and Predictors of Early Dropout. Fischer, MS., Bhatia, V., Baddeley, JL., et al.[2019]

Cognitive-behavioral couple therapy (CBCT) is effective in reducing relationship distress, with strong empirical support from multiple meta-analyses across trials in the U.S., Europe, and Australia.

When adapted for individual psychological issues, couple-based interventions using CBCT principles are at least as effective as individual cognitive behavioral therapy (CBT) and often yield better outcomes, particularly when both partners are involved in the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-Behavioral Couple Therapies: Review of the Evidence for the Treatment of Relationship Distress, Psychopathology, and Chronic Health Conditions. Fischer, MS., Baucom, DH., Cohen, MJ.[2018]

Couple therapy significantly reduces both mental and physical health service utilization among U.S. military veterans, with a notable decrease in visits observed in the year following treatment, particularly for those who completed the therapy.

On average, the cost of healthcare services per person decreased by approximately $930.33 in the year after couple therapy, highlighting the potential economic benefits of systemic interventions for mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Couple Therapy on Service Utilization among Military Veterans: The Moderating Roles of Pretreatment Service Utilization and Premature Termination. Madsen, JW., Tomfohr-Madsen, LM., Doss, BD.[2018]

A study involving 7391 primary care patients referred to a Collaborative Care Model (CoCM) behavioral health provider found that most patients engaged in at least one visit, indicating the model's general acceptability.

However, patients with suicidal ideation (SI) engaged at lower rates, with only 61.4% of those reporting SI on several days attending compared to 67.5% of those without SI, highlighting a need for targeted strategies to improve engagement among this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating individuals with suicidal ideation in primary care: Patient-level characteristics associated with follow-up in the Collaborative Care Model. Candon, M., Wolk, CB., Kattan Khazanov, G., et al.[2023]

The 12-month Collaborative Care (CC) intervention showed that patients with poorly controlled Type 2 Diabetes (T2D) and depression were more likely to maintain significant improvements in depressive symptoms and glucose levels at 36 months compared to those receiving usual care.

While there were no overall differences in health outcomes between the CC and usual care groups at 36 months, patients in the CC group who had improved outcomes at 12 months were more likely to sustain those improvements, indicating the long-term benefits of the CC approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Effects of a Collaborative Care Model on Metabolic Outcomes and Depressive Symptoms: 36-Month Outcomes from the INDEPENDENT Intervention. Suvada, K., Ali, MK., Chwastiak, L., et al.[2023]

The collaborative care management (CoCM) model can be successfully adapted for use in a low-barrier HIV clinic, which serves a complex patient population with high levels of mental illness and substance use, demonstrating its flexibility beyond traditional primary care settings.

Despite the need for significant adaptations to fit the unique context of the HIV clinic, the core structural elements of CoCM were preserved, indicating that effective behavioral health integration can be achieved even in nonconventional healthcare environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of the collaborative care model to integrate behavioral health care into a low-barrier HIV clinic. Dombrowski, JC., Halliday, S., Tsui, JI., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10591926/

Brief relationship support as a selective suicide prevention ...

This study explores the feasibility, safety, acceptability, and promise of utilizing the 3-session Relationship Checkup (RC) in veterans with mental health and ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05525676

Relationship Checkups to Reduce Veteran Suicide Risk

This study compares two approaches to working with Veterans that have a mix of mental health and relationship concerns in primary care.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37594162/

Brief relationship support as a selective suicide prevention ...

This study explores the feasibility, safety, acceptability, and promise of utilizing the 3-session Relationship Checkup (RC) in veterans with mental health and ...

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/abs/10.1111/sltb.12983

Brief relationship support as a selective suicide prevention ...

This study explores the feasibility, safety, acceptability, and promise of utilizing the 3-session Relationship Checkup (RC) in veterans with mental health and ...

5.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/61/NCT06011161/Prot_SAP_001.pdf

The Brief Relationship Checkup: A 3-Session Program to ...

The purpose of this project is to pilot a brief intervention with Veterans screening positive for known suicide risk factors (i.e., depression, alcohol use, ...

6.

withpower.com

withpower.com/trial/phase-relationship-distress-9-2022-27a2c

Couples-Based Therapy for Reducing Veteran Suicide Risk

This study compares two approaches to working with Veterans that have a mix of mental health and relationship concerns in primary care.

7.

militaryreach.auburn.edu

militaryreach.auburn.edu/detail?id=d2080927-cbb4-4469-b2d6-3c5b68a984b0&pdf=research

Research Report - Military REACH - Auburn University

Relationship Checkup demonstrated feasibility, safety, acceptability, and preliminary effectiveness for couples at risk for suicidality. DOI. https://doi.org/ ...