Suicide Risk Interventions
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT05931289
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Suicide
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Enhanced Crisis Response Planning (ECRP) — BEHAVIORALUsing 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.
- Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT) — BEHAVIORALThis 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.
Study Details
The suicide rate among active duty service members and Veterans increased substantially following the onset of post-9/11 conflicts in Iraq and Afghanistan. Accordingly, Veteran suicide prevention has been identified as a national healthcare and research priority. The investigators will recruit 136 female and male Veterans who have been hospitalized for suicide risk and randomly assign them to receive one of two psychotherapy treatments for suicide risk after they leave the hospital. The goals of this study are to examine if a) a longer psychotherapy causes greater improvements in coping skills and reductions in negative suicidal thinking, b) a longer psychotherapy is more effective in reducing suicide risk, and c) if Veterans with a history of multiple suicide attempts are more likely to benefit from the longer psychotherapy. Additionally, this study will use magnetic resonance imaging (MRI) neuroimaging scans of Veterans shortly after they leave the hospital and again 4- and 12-months later. This study will explore a) if brain markers can predict suicide attempts, b) if brain markers change over time as suicide risk changes, and c) if brain markers change differently for the two types of psychotherapy.
Key Dates
- Start date
- Mar 3, 2025
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 136 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Enhanced Crisis Response PlanningUsing 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.
- Active Comparator: Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT)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.
Primary Outcome Measure
Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R) [ Time Frame: Change since hospital discharge (via administrations at the 2, 4, 8, and 12-month post-discharge assessments) ]
Central Contacts
- Michael S Esterman, PhD(857) 364-4362
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130-4817 | Michael S Esterman, PhD (PRINCIPAL_INVESTIGATOR) |
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