Couple-Based Intervention for Suicide

(TR&ST Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Chandra E Khalifian, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: VA Office of Research and Development

Disqualifiers: Substance use, Psychosis, Mania, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new therapy program called TR&ST, which helps veterans and their partners improve their relationship to reduce suicidal thoughts. The program combines techniques from suicide prevention and couple therapy. It targets veterans because they have higher suicide rates, often linked to relationship problems. TR&ST seemed acceptable to couples and received high satisfaction ratings.

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 for Relationships and Safety Together (TR&ST) for suicide prevention?

The Treatment for Relationships and Safety Together (TR&ST) is a couple-based approach aimed at preventing suicide, and while specific data on its effectiveness is limited, similar interventions like the Safety Planning Intervention (SPI) have shown positive results. SPI has been associated with reduced suicidal thoughts and behaviors, decreased depression and hopelessness, and improved treatment engagement, suggesting that structured interventions focusing on safety and relationships can be beneficial. ^{1 2 3 4 5}

Is the couple-based intervention for suicide generally safe for humans?

The couple-based intervention, Treatment for Relationships and Safety Together (TR&ST), is a comprehensive treatment for suicide prevention. While specific safety data for TR&ST is not detailed, related interventions like Safety Planning have been found to be feasible and acceptable, suggesting a general level of safety in similar contexts. ^{2 3 5 6 7}

How is the Treatment for Relationships and Safety Together (TR&ST) different from other treatments for suicide prevention?

The Treatment for Relationships and Safety Together (TR&ST) is unique because it is the first comprehensive couple-based treatment specifically designed to prevent suicide by focusing on improving relationship dynamics, which is not a common approach in standard suicide interventions. ^{2 3 5 8 9}

Research Team

Chandra E Khalifian, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

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

I do not speak English.

Trial Timeline

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)

Treatment Details

Interventions

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

Participant Groups

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+

Dr. Grant Huang

VA Office of Research and Development

Acting Chief Research and Development Officer

PhD in Medical Psychology and Master of Public Health from the Uniformed Services University of Health Sciences

Dr. Erica M. Scavella

VA Office of Research and Development

Chief Medical Officer since 2022

MD from University of Massachusetts School of Medicine

Findings from Research

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]

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 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]

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 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]

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]

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 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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

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

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

Utilizing the couple relationship to prevent suicide: A preliminary examination of Treatment for Relationships and Safety Together. [2022]

3. United States 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. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

Psychiatric Hospitalization for Attempted Suicide and Reattempt at the One-Year Follow-Up. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Evaluating the Effectiveness of Safety Plans for Military Veterans: Do Safety Plans Tailored to Veteran Characteristics Decrease Suicide Risk? [2019]

7. England pubmed.ncbi.nlm.nih.gov

Safety plan use in the daily lives of adolescents after psychiatric hospitalization. [2023]

8. 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]

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

A Pilot Randomized Control Trial of a Dyadic Safety Planning Intervention: Safe Actions for Families to Encourage Recovery (SAFER). [2023]