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Couple-Based Intervention for Suicide (TR&ST Trial)
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
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
TR&ST Trial Summary
This trial is testing a novel suicide-specific couple-based intervention called TR&ST, which adapts an evidence-based intervention for suicide, BCBT for Suicide, to be dyadically focused and integrates CBCT skills. The goal is to reduce the severity of suicidal thoughts.
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.Check my eligibility
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.See study design
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.
TR&ST Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in severity of suicidal ideation from baseline
Secondary outcome measures
Change in negative communication from baseline
Change in perceived burdensomeness and thwarted belonging from baseline
Change in positive bonding from baseline
+2 moreOther outcome measures
Change in relationship conflict from baseline
Change in severity of depression from baseline
Changes in Posttraumatic Stress Disorder severity from baseline
+3 moreTR&ST 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).
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,040 Total Patients Enrolled
39 Trials studying Suicide
6,402 Patients Enrolled for Suicide
Chandra E Khalifian, PhDPrincipal InvestigatorVA San Diego Healthcare System, San Diego, CA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English.Either my partner or I have been diagnosed with psychosis or mania.I am under conservatorship and need someone else to consent for me.I am unable to complete the required health assessments.I understand the information given and can make decisions about my health care.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment for Relationships and Safety Together (TR&ST)
- Group 2: VA Standard Suicide Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being tracked for this research project?
"Affirmative. Clinicaltrials.gov's data displays that this research project is in the process of recruiting participants, which was posted on April 15th 2021 and last updated on March 10th 2022. The study requires 144 people to be recruited at 1 site."
Answered by AI
Is the research team actively enrolling participants in this trial?
"Affirmative. Information hosted on clinicaltrials.gov confirms that enrollment for this medical study, which was first posted on April 15th 2021, is still open. Approximately 144 patients need to be recruited from a single location."
Answered by AI
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