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ECRP + BCBT for Suicide Risk Reduction
Phase 2
Waitlist Available
Led By Michael S Esterman, 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 worst point (administered at baseline and the 2, 4, 8, and 12-month post-discharge assessments)
Awards & highlights
Study Summary
This trial is exploring if longer psychotherapy & neuroimaging scans can help reduce suicide risk in Veterans. It's using 136 participants to see if the treatments are effective & how brain markers may predict suicide attempts.
Who is the study for?
This trial is for English-speaking Veterans who've been hospitalized due to recent suicidal thoughts or attempts. They must be able to attend 12 therapy sessions and 3 MRI scans post-discharge. It's not suitable for those with significant cognitive impairments or current psychotic/manic features.Check my eligibility
What is being tested?
The study compares two psychotherapies: Brief Cognitive Behavioral Therapy (BCBT) and Enhanced Crisis Response Planning (ECRP), assessing their effectiveness in improving coping skills, reducing negative thinking, and lowering suicide risk among Veterans.See study design
What are the potential side effects?
While the trial involves psychological interventions rather than medications, participants may experience emotional discomfort discussing sensitive topics during therapy sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ worst point (administered at baseline and the 2, 4, 8, and 12-month post-discharge assessments)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~worst point (administered at baseline and the 2, 4, 8, and 12-month post-discharge assessments)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
Secondary outcome measures
Scale for Suicide Ideation (SSI)
Trial Design
2Treatment groups
Active Control
Group I: Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT)Active Control1 Intervention
This weekly, 12-session intervention involves completion of an enhanced crisis response plan, as well as emotion regulation skills training, learning strategies to identify and challenge thinking patterns that contribute to suicide risk, and increased engagement in personally meaningful activities.
Group II: Enhanced Crisis Response PlanningActive Control1 Intervention
Using supportive listening, a therapist conducts a brief interview to gather information about lifetime suicide attempt history and recent SI. The therapist then works with the client to identify a) warning signs for being in crisis, b) self-management/distraction strategies, c) reasons for living, d) sources of social support the client could contact in the event of a crisis, and e) crisis resources (e.g., veterans crisis line, contact information for current providers and local emergency resources). Steps for each of these, as well as specific contacts for social support and professional services are written on an index card provided to the patient and the patient is encouraged to keep the card in an accessible place (e.g., wallet) so it can be utilized in the event of a crisis.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,467 Total Patients Enrolled
38 Trials studying Suicide
5,482 Patients Enrolled for Suicide
Michael S Esterman, PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Daniel J. Lee, PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend 15 sessions after leaving the hospital.I can understand and agree to the study's consent form.
Research Study Groups:
This trial has the following groups:- Group 1: Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT)
- Group 2: Enhanced Crisis Response Planning
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.
Are there any available slots to participate in the clinical trial?
"The clinicaltrials.gov database shows that this particular medical trial, originally posted on the 1st of November 2023 and last updated sometime in late June of 2023, is no longer actively recruiting patients. Nevertheless, there are still 179 other similar trials currently seeking participants."
Answered by AI
Has Enhanced Crisis Response Planning received clearance from the FDA?
"As this is a Phase 2 trial, with only limited data supporting safety but no information regarding efficacy, Enhanced Crisis Response Planning received an estimated risk rating of 2."
Answered by AI
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