What is the mechanism of action of this treatment?

Common treatments for suicide, such as Brief Cognitive Behavioral Therapy (BCBT) and Cognitive Behavioral Couple Therapy (CBCT), work by addressing both individual and relational factors that contribute to suicidal thoughts. BCBT helps patients identify and change negative thought patterns and behaviors, develop coping strategies, and create safety plans. CBCT focuses on improving relationship satisfaction by enhancing communication, conflict resolution, and emotional support within couples. Integrating these therapies, as in the TR&ST trial, is crucial because it not only helps individuals manage their distress but also strengthens their intimate relationships, which can significantly reduce the risk of suicide.

What side effects are associated with this type of intervention?

The most common side effects of psychotherapeutic treatments like Brief Cognitive Behavioral Therapy for Suicide and Cognitive Behavioral Couple Therapy include emotional distress, temporary increases in anxiety or depressive symptoms, and potential strain on relationships. These therapies do not typically involve medication, so they generally have fewer physical side effects. Close collaboration with therapists can help manage these emotional and relational challenges.

What prior FDA approvals exist?

The FDA has not specifically approved any treatments that combine Brief Cognitive Behavioral Therapy (BCBT) for Suicide and Cognitive Behavioral Couple Therapy (CBCT) as seen in the TR&ST trial. However, the FDA has approved medications such as esketamine (Spravato) for treatment-resistant depression, which can include suicidal ideation. Additionally, Cognitive Behavioral Therapy (CBT) is widely recognized and recommended for managing suicidal thoughts, though it does not require FDA approval as it is a form of psychotherapy rather than a pharmacological treatment.

What other types of research exist?

Promising novel alternatives to TR&ST for suicide patients include: 1) Dialectical Behavior Therapy (DBT), which focuses on emotional regulation and interpersonal effectiveness; 2) Collaborative Assessment and Management of Suicidality (CAMS), which involves a collaborative approach between the patient and therapist to understand and manage suicidal thoughts; and 3) Attachment-Based Family Therapy (ABFT), which aims to improve family relationships and support systems to reduce suicidal ideation. These therapies have shown efficacy in clinical trials and are recommended for their comprehensive approach to addressing both individual and relational factors in suicide prevention.

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

Q: What other types of research exist?

Promising novel alternatives to TR&#x26;ST for suicide patients include: 1) Dialectical Behavior Therapy (DBT), which focuses on emotional regulation and interpersonal effectiveness; 2) Collaborative Assessment and Management of Suicidality (CAMS), which involves a collaborative approach between the patient and therapist to understand and manage suicidal thoughts; and 3) Attachment-Based Family Therapy (ABFT), which aims to improve family relationships and support systems to reduce suicidal ideation. These therapies have shown efficacy in clinical trials and are recommended for their comprehensive approach to addressing both individual and relational factors in suicide prevention.

N/A

Recruiting

Led By Chandra E Khalifian, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Not English speaking

Has or meets criteria for a current diagnosis of psychosis and/or mania in either member of the couple

Timeline

Screening 3 weeks

Treatment Varies

Follow Up delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves psychological therapy rather than medication, traditional side effects are not expected; however participants may experience emotional discomfort discussing personal issues during sessions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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

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I am under conservatorship and need someone else to consent for me.

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I am unable to complete the required health assessments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and delivered at baseline, 7 weeks after baseline (mid-treatment), 13 weeks after baseline (post-treatment), and 25 weeks after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in severity of suicidal ideation from baseline

Secondary study objectives

Change in negative communication from baseline

Change in perceived burdensomeness and thwarted belonging from baseline

Change in positive bonding from baseline

+2 more

Other study objectives

Change in relationship conflict from baseline

Change in severity of depression from baseline

Changes in Posttraumatic Stress Disorder severity from baseline

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment for Relationships and Safety Together (TR&ST)Experimental Treatment1 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 InterventionActive Control1 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).

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for suicide, such as Brief Cognitive Behavioral Therapy (BCBT) and Cognitive Behavioral Couple Therapy (CBCT), work by addressing both individual and relational factors that contribute to suicidal thoughts. BCBT helps patients identify and change negative thought patterns and behaviors, develop coping strategies, and create safety plans. CBCT focuses on improving relationship satisfaction by enhancing communication, conflict resolution, and emotional support within couples. Integrating these therapies, as in the TR&ST trial, is crucial because it not only helps individuals manage their distress but also strengthens their intimate relationships, which can significantly reduce the risk of suicide.