Couple-Based Intervention for Suicide

(TR&ST Trial)

Overseen By Leslie A. Morland, PsyD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Substance use, Psychosis, Mania, others

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

Compensation: Varies

Number of Visits: 26

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new couple-based therapy aimed at preventing suicide among Veterans. It combines cognitive-behavioral techniques with relationship counseling to help couples improve communication and manage distress together. The trial compares this new approach, called Treatment for Relationships and Safety Together (TR&ST), to the standard suicide intervention usually offered at VA facilities. Veterans who have recently experienced suicidal thoughts and are in a committed relationship for at least 6 months, with a partner willing to participate, might be a good fit. The goal is to determine if enhancing relationship quality can reduce suicidal thoughts and improve interpersonal relationships. As an unphased trial, this study offers Veterans the opportunity to contribute to innovative research that could enhance mental health support for couples.

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 prior data suggests that this couple-based intervention is safe for suicide prevention?

Research shows that the Treatment for Relationships and Safety Together (TR&ST) offers a promising and safe option for preventing suicide in veterans. This method adapts Brief Cognitive Behavioral Therapy (BCBT) to focus on couples, incorporating skills from Cognitive Behavioral Couple Therapy (CBCT). Early results indicate that veterans and their partners view TR&ST as a promising and acceptable treatment. Although clear data on side effects is not yet available, positive feedback from participants in earlier studies suggests that TR&ST is well-tolerated. This implies it is a safe choice for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Treatment for Relationships and Safety Together (TR&ST) program because it goes beyond traditional suicide interventions by focusing on the relationship dynamics that can influence suicidal thoughts and behaviors. Unlike typical treatments that concentrate solely on individual risk factors, TR&ST integrates couples therapy into the suicide prevention strategy, providing a unique approach that addresses relationship distress and its impact on mental health. Through eleven structured sessions, it emphasizes communication skills, emotion regulation, and conflict management, helping couples collaboratively tackle suicidal ideation and foster healthier relationships. This innovative method of involving both partners could significantly enhance support systems and lead to more effective prevention of suicide.

What evidence suggests that this trial's treatments could be effective for suicide prevention?

This trial will compare the effectiveness of two interventions for suicide prevention. Research has shown that TR&ST, a program combining couple therapy with cognitive behavioral techniques, may help reduce suicidal thoughts. Studies have found that improving how couples interact can lessen feelings of being a burden and hopelessness, which are linked to suicidal thoughts. TR&ST has been successfully used with couples, leading to better relationship satisfaction and communication. These improvements are important because relationship problems often trigger suicidal feelings. While researchers continue to study the treatment, early results are promising for its effectiveness in preventing suicide among veterans. Meanwhile, the VA Standard Suicide Intervention, which participants in another arm of this trial may receive, includes suicide risk assessment, safety planning, and follow-up contacts, and has significantly reduced suicidal behavior. ^{5 6 7 8 9}

Who Is on the Research Team?

Chandra E Khalifian, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Are You a Good Fit for This Trial?

This trial is for U.S. military Veterans experiencing current suicidal thoughts or who have attempted suicide in the past three months. They must be in a committed relationship for at least six months, with a partner willing to participate, and plan to stay in the San Diego area for seven months. Exclusions include non-English speakers, those unable to complete assessments, history of severe aggression towards their partner within a year, substance abuse needing immediate detoxification, or having psychosis/mania.

Inclusion Criteria

In committed relationship for at least 6 months

An intimate partner who is willing to participate

Plans to remain in the San Diego region for 7 months

Exclusion Criteria

Any perpetration of severe physical or sexual relationship aggression in the past year (as assessed by the CTS-2)

Current substance use requiring immediate detoxification or outpatient plan directed specifically to residential substance use disorder (not mental health) services

Either my partner or I have been diagnosed with psychosis or mania.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Refinement

Refinement of TR&ST intervention with 12 couples, focusing on cognitive-behavioral conceptualization of suicide and relationship distress

11 weeks

11 sessions (in-person)

Pilot Randomized Controlled Trial

Pilot RCT of TR&ST compared to VA Standard Suicide Intervention with 60 couples, involving suicide risk assessment, safety planning, and follow-up

11 weeks

11 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, mid-treatment, post-treatment, and 3-months post-treatment

3 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Treatment for Relationships and Safety Together (TR&ST)
• VA Standard Suicide Intervention

Trial Overview

The study tests 'Treatment for Relationships and Safety Together (TR&ST)'—a couple-based intervention integrating cognitive behavioral therapy aimed at preventing suicide among Veterans by focusing on improving intimate relationships. It's compared against standard VA interventions over an 11-week period with follow-ups up to three months post-treatment.

How Is the Trial Designed?

Group I: Treatment for Relationships and Safety Together (TR&ST) Experimental Treatment 1 Intervention

TR\&ST consists of eleven 90-minute sessions delivered in three phases. During phase one, couples receive a tailored cognitive-behavioral conceptualization of suicide and relationship distress based on clinical interview, as well as psychoeducation about their bidirectional influences. They also engage in behavioral activation focused on positive couple activities, emotion regulation, distress tolerance, and conflict management strategies. In phase two, couples learn communication skills and discuss suicidal thoughts and behaviors, as well as their relationship challenges that interact with suicidal thoughts and behavior. Phase three is focused on conjoint thought challenging to shift dysfunctional cognitions related to suicide and relationship problems.

Group II: VA Standard Suicide Intervention Active Control 1 Intervention

Our active control condition is standardized and contains the elements of standard practice suicide-specific intervention delivered at the VA, which include: 1) suicide risk assessment using the CSSR-S, 2) VA Safety Planning Intervention, 3) timely referral to VA mental health outpatient care, including couples intervention (engagement will be tracked), and 4) Suicide Prevention Coordinator (SPC) follow-up contacts (which have been found to significantly reduce suicidal behavior).

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

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]

The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among adults experiencing suicide-related distress, based on a systematic review of 26 studies.

The SPI is adaptable and can be delivered in various formats (in-person or online) and as a standalone or combined intervention, making it a flexible tool in suicide prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. Ferguson, M., Rhodes, K., Loughhead, M., et al.[2022]

The Treatment for Relationships and Safety Together (TR&ST) program was successfully delivered to five couples, showing improvements in relationship functioning and reductions in suicidal ideation among veterans.

TR&ST demonstrated high acceptability with 100% retention and no reported suicide-related behaviors during the study, suggesting it could be a promising approach for suicide prevention in veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing the couple relationship to prevent suicide: A preliminary examination of Treatment for Relationships and Safety Together. Khalifian, CE., Leifker, FR., Knopp, K., et al.[2022]

The SAFER intervention, a family-based treatment for Veterans at moderate risk for suicide, showed significant reductions in suicide ideation compared to standard individual Safety Planning Intervention, indicating its potential efficacy in suicide prevention.

The SAFER approach improved Veterans' coping strategies and enhanced the support from their partners, suggesting that involving family members in safety planning can be beneficial, although further intensive family work may be needed to address deeper relational issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Randomized Control Trial of a Dyadic Safety Planning Intervention: Safe Actions for Families to Encourage Recovery (SAFER). Goodman, M., Sullivan, SR., Spears, AP., et al.[2023]

In a study of 191 individuals hospitalized for suicide attempts, those receiving usual treatment plus a telephone follow-up program (TAU + T) showed a lower recurrence of suicide attempts compared to those receiving usual treatment alone (TAU).

Overall, 31.4% of participants attempted suicide again within a year, but the follow-up program appeared to help reduce this risk, particularly for those with a history of previous attempts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric Hospitalization for Attempted Suicide and Reattempt at the One-Year Follow-Up. Goñi-Sarriés, A., Yárnoz-Goñi, N., López-Goñi, JJ.[2022]

The SAFE VET protocol aims to test a brief intervention that combines Safety Planning Intervention with structured follow-up to effectively reduce suicide risk among Veterans in emergency departments.

This study addresses a significant gap in evidence-based interventions for Veterans at risk of suicide, focusing on enhancing their engagement in outpatient behavioral health treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and study protocol for a two-part intervention: Safety planning and structured follow-up among veterans at risk for suicide and discharged from the emergency department. Currier, GW., Brown, GK., Brenner, LA., et al.[2022]

The case study of a 55-year-old housewife who committed suicide after psychiatric inpatient treatment highlights the complexities of managing patients with a history of severe suicide attempts, emphasizing the need for better understanding of their social and psychological contexts.

The therapy team concluded that insights from this tragic case could lead to improved management strategies for inpatient treatment following suicide attempts, suggesting that learning from unsuccessful interventions is crucial for enhancing future care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicide following attempted suicide: a study of an unsuccessful intervention. Etzersdorfer, E.[2022]

Higher quality Safety Plans (SPs) for veterans, which are more personally relevant, are associated with a decreased likelihood of future suicide-related behaviors, based on a study of 68 veterans over several years.

Specifically, the component of the SP that identifies people and places for distraction was particularly effective in reducing reports of self-harm and suicide attempts, indicating that personalized elements in SPs may enhance their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Safety Plans for Military Veterans: Do Safety Plans Tailored to Veteran Characteristics Decrease Suicide Risk? Green, JD., Kearns, JC., Rosen, RC., et al.[2019]

Over 90% of adolescents recently hospitalized for suicide risk reported having access to their safety plans after discharge, indicating high retention and potential for use during critical periods.

While safety plan use and suicidal ideation both declined over time, the relationship between them varied by sex: girls showed a correlation in changes, while boys' safety plan use decreased regardless of their suicidal ideation changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety plan use in the daily lives of adolescents after psychiatric hospitalization. May, AM., Al-Dajani, N., Ballard, ED., et al.[2023]

Citations

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clinicaltrial.be/en/details/45937?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Treatment for Relationships and Safety Together (TR&ST)

TR&ST adapts an evidence-based intervention for suicide, Brief Cognitive Behavioral Therapy (BCBT) for Suicide, to be dyadically focused and ...

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Utilizing the couple relationship to prevent suicide

Results: TR&ST was feasible to deliver. Veteran and partner relationship functioning improved and veteran perceived burdensomeness, thwarted ...

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Couple-Based Intervention for Suicide (TR&ST Trial)

The Treatment for Relationships and Safety Together (TR&ST) program was successfully delivered to five couples, showing improvements in relationship functioning ...

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Treatment for Relationships and Safety Together

TR&ST adapts an evidence-based intervention for suicide, Brief Cognitive Behavioral Therapy (BCBT) for Suicide, to be dyadically focused and integrates ...

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Utilizing the couple relationship to prevent suicide

Results TR&ST was feasible to deliver. Veteran and partner relationship functioning improved and veteran perceived burdensomeness, thwarted ...

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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 ...

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Treatment for Relationships and Safety Together

The intervention period is 11-weeks and the entire study period is approximately 7 months. Couples in both phases will be quantitatively ...

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NCT07012824 | Couple-Based Crisis Safety Planning

Crisis response planning (CRP; also referred to as "Safety Planning") is a brief, one-time intervention that teaches individuals to notice warning signs of an ...

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Experiences of veterans and partners engaged in ...

Conclusion: Preliminary results suggest that TR&ST is a promising treatment option for suicide prevention in Veterans.