Couples-Based Therapy for Reducing Veteran Suicide Risk

(BRC RCT Trial)

Recruiting at 1 trial location

Overseen By Dev J Crasta

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

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Couples-Based Therapy for Reducing Veteran Suicide Risk?

Research shows that the Collaborative Care Model, which is part of the treatment, is effective in improving mental health outcomes by integrating behavioral health into primary care settings. This approach has been successful in managing depression and other mental health conditions, suggesting potential benefits for reducing suicide risk among veterans. ^{1 2 3 4 5}

Is couples-based therapy for reducing veteran suicide risk safe for humans?

The Collaborative Care Model, which includes approaches like Co-Located Collaborative Care, has been studied in various settings and is generally considered safe for integrating mental health care into primary care. However, specific safety data for couples-based therapy in reducing veteran suicide risk is not detailed in the available research. ^{1 2 3 5 6}

How is the Couples-Based Therapy for Reducing Veteran Suicide Risk treatment different from other treatments?

This treatment is unique because it focuses on improving relationship dynamics through a brief, three-session intervention called the Relationship Checkup, which is specifically designed to address relationship and mental health concerns in veterans. Unlike traditional individual therapies, this approach involves both partners and aims to enhance relationship satisfaction, which can indirectly reduce suicide risk. ^{7 8 9 10 11}

Research Team

Dev J Crasta

Principal Investigator

VA Finger Lakes Healthcare System, Canandaigua, NY

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. England 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. [2023]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Collaborative Care to Improve Access and Quality in School-Based Behavioral Health. [2020]

5. United States 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Adaptation of the collaborative care model to integrate behavioral health care into a low-barrier HIV clinic. [2023]

7. England 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States 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. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Couple Therapy with Veterans: Early Improvements and Predictors of Early Dropout. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Design of a randomized superiority trial of a brief couple treatment for PTSD. [2023]