Couples-Based Therapy for Reducing Veteran Suicide Risk

(BRC RCT Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Dev J Crasta

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

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

No Placebo Group

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.

Trial 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) (Behavioral Intervention)
• Co-Located Collaborative Care (CCC) (Behavioral Intervention)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

VA Finger Lakes Healthcare System, Canandaigua, NY Canandaigua, NY

Canandaigua VA Medical Center, Canandaigua, NY Canandaigua, NY

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1691

Patients Recruited

3,759,000+

References

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

Behavioral health providers' perspectives of delivering behavioral health services in primary care: a qualitative analysis. [2021] Co-located, collaborative care (CCC) is one component of VA's model of Integrated Primary Care that embeds behavioral health providers (BHPs) into primary care clinics to treat commonly occurring mental health concerns among Veterans. Key features of the CCC model include time-limited, brief treatments (up to 6 encounters of 30 minutes each) and emphasis on multi-dimensional functional assessment. Although CCC is a mandated model of care, the barriers and facilitators to implementing this approach as identified from the perspective of BHPs have not been previously identified.

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] The Collaborative Care Model (CoCM) is an evidence-based approach which embeds behavioral health providers (BHPs) into primary care. Whether patients with suicidal ideation (SI) are willing to engage in CoCM is unclear.

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] Collaborative care (CC) is a multicomponent team-based approach to providing mental health care with systematic integration into outpatient medical settings. The 12-month INDEPENDENT CC intervention improved joint disease control measures in patients with both depression and diabetes at 12 and 24 months following randomization.

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

Collaborative Care to Improve Access and Quality in School-Based Behavioral Health. [2020] Collaborative care (CC) is a well-established approach for the delivery of accessible behavioral health services in integrated health care settings. Substantial evidence supports its effectiveness in improving the quality and outcomes of adult services, and growing research indicates utility with child and adolescent populations.

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] Collaborative chronic care models (CCMs) have extensive randomized clinical trial evidence for effectiveness in serious mental illnesses, but little evidence exists regarding their feasibility or effect in typical practice conditions.

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] The collaborative care management (CoCM) model is an evidence-based intervention for integrating behavioral health care into nonpsychiatric settings. CoCM has been extensively studied in primary care clinics, but implementation in nonconventional clinics, such as those tailored to provide care for high-need, complex patients, has not been well described.

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] Close relationship problems play a key role in many contemporary theories of suicide. However, the potential of relationship support in suicide prevention is understudied. This study explores the feasibility, safety, acceptability, and promise of utilizing the 3-session Relationship Checkup (RC) in veterans with mental health and romantic relationship concerns.

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] Cognitive-behavioral couple therapy (CBCT) is an approach to assisting couples that has strong empirical support for alleviating relationship distress. This paper provides a review of the empirical status of CBCT along with behavioral couple therapy (BCT), as well as the evidence for recent applications of CBCT principles to couple-based interventions for individual psychopathology and medical conditions. Several meta-analyses and major reviews have confirmed the efficacy of BCT and CBCT across trials in the United States, Europe, and Australia, and there is little evidence to support differential effectiveness of various forms of couple therapy derived from behavioral principles. A much smaller number of effectiveness studies have shown that successful implementation in community settings is possible, although effect sizes tend to be somewhat lower than those evidenced in randomized controlled trials. Adapted for individual problems, cognitive-behavioral couple-based interventions appear to be at least as effective as individual cognitive behavioral therapy (CBT) across a variety of psychological disorders, and often more effective, especially when partners are substantially involved in treatment. In addition, couple-based interventions tend to have the unique added benefit of improving relationship functioning. Findings on couple-based interventions for medical conditions are more varied and more complex to interpret given the greater range of target outcomes (psychological, relational, and medical variables).

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] Couple therapy reduces relational and individual distress and may affect utilization of other health services, particularly among higher service utilizers. Although average decreases in service utilization are predicted among recipients of couple therapy, low utilizers of services may appropriately increase use. The relationship between couple therapy and service utilization was examined among a sample of 179 U.S. military veterans who received treatment in Veterans Affairs (VA) specialty couple therapy clinics. Consistent with hypotheses, overall mental and physical health visits decreased from the 12 months preceding couple therapy to the 12 months following treatment. Moderator analyses showed that decreases were greatest among individuals who were rated by their therapist as having completed a full course of couple therapy, suggesting that change was attributable to intervention. Pretreatment service utilization also moderated observed change-higher utilizers' use of services decreased substantially, whereas lower utilizers' slightly increased. Cost analyses revealed that the estimated per person mean cost in our sample decreased by $930.33 in the year following compared to the year prior to couple therapy, as per 2008 VA cost data. As service utilization data were only available for one partner and only for 1 year posttherapy, the true magnitude of this effect may be underestimated. Our findings are relevant to policy makers as they demonstrate that couple therapy reduces average service utilization and associated costs and addresses calls for analyses of cost effectiveness of systemic interventions.

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

Couple Therapy with Veterans: Early Improvements and Predictors of Early Dropout. [2019] Family services within Veterans Affairs Medical Centers fulfill an important role in addressing relationship distress among Veterans, which is highly prevalent and comorbid with psychopathology. However, even for evidence-based couple therapies, effectiveness is weaker compared to controlled studies, maybe because many Veteran couples drop out early and do not reach the "active" treatment stage after the 3-4 session assessment. In order to improve outcomes, it is critical to identify couples at high risk for early dropout, and understand whether couples may benefit from the assessment as an intervention. The current study examined (a) demographics, treatment delivery mode, relationship satisfaction, and psychological symptoms as predictors of dropout during and immediately following the assessment phase, and (b) changes in relationship satisfaction during assessment. 174 couples completed questionnaires during routine intake procedures. The main analyses focused on 140 male Veterans and their female civilian partners; 36.43% dropped out during the assessment phase and 24.74% of the remaining couples immediately following the first treatment session. More severe depressive symptoms in non-Veteran partners were associated with dropout during assessment. Relationship satisfaction improved significantly during the assessment phase for couples who did not drop out, with larger gains for non-Veteran partners. No demographics or treatment delivery mode were associated with dropout. Although more research is needed on engaging couples at risk for early dropout and maximizing early benefits, the findings suggest that clinicians should attend to the civilian partner's and Veteran's depressive symptoms at intake and consider the assessment part of active treatment.

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

Design of a randomized superiority trial of a brief couple treatment for PTSD. [2023] Interpersonal difficulties are common among veterans with posttraumatic stress disorder (PTSD) and are associated with poorer treatment response. Treatment outcomes for PTSD, including relationship functioning, improve when partners are included and engaged in the therapy process. Cognitive-behavioral conjoint therapy for PTSD (CBCT) is a manualized 15-session intervention designed for couples in which one partner has PTSD. CBCT was developed specifically to treat PTSD, engage a partner in treatment, and improve interpersonal functioning. However, recent research suggests that an abbreviated CBCT protocol may lead to sufficient gains in PTSD and relationship functioning, and yield lower dropout rates. Likewise, many veterans report a preference for receiving psychological treatments through clinical videoteleconferencing (CVT) rather than traditional face-to-face modalities that require travel to VA clinics. This manuscript describes the development and implementation of a novel randomized controlled trial (RCT) that examines the efficacy of an abbreviated 8-session version of CBCT ("brief CBCT," or B-CBCT), and compares the efficacy of this intervention delivered via CVT to traditional in-person platforms. Veterans and their partners were randomized to receive B-CBCT in a traditional Veterans Affairs office-based setting (B-CBCT-Office), CBCT through CVT with the veteran and partner at home (B-CBCT-Home), or an in office-delivered, couple-based psychoeducation control condition (PTSD Family Education). This study is the first RCT designed to investigate the delivery of B-CBCT specifically to veterans with PTSD and their partners, as well as to examine the delivery of B-CBCT over a CVT modality; findings could increase access to care to veterans with PTSD and their partners.