Suicide Risk Interventions
2 other identifiers
interventional
136
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2025
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 5, 2023
CompletedStudy Start
First participant enrolled
March 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
February 17, 2026
February 1, 2026
2.8 years
June 26, 2023
February 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-Injurious Thoughts and Behaviors Interview-Revised (SITBI-R)
The SITBI-R is a structured interview assessment of the frequency, intensity, and characteristics of self-injurious thoughts and behaviors. The SITBI-R will be used to assess lifetime history of suicide attempts at baseline and the number, approximate date, method, and injuries resulting from any suicide attempts occurring during the 12-month period following discharge via administrations at the 2, 4, 8, and 12-month post-discharge assessments.
Change since hospital discharge (via administrations at the 2, 4, 8, and 12-month post-discharge assessments)
Secondary Outcomes (1)
Scale for Suicide Ideation (SSI)
Worst point (administered at baseline and the 2, 4, 8, and 12-month post-discharge assessments)
Study Arms (2)
Enhanced Crisis Response Planning
ACTIVE COMPARATORUsing 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)
ACTIVE COMPARATORThis 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- hospitalization for a recent suicidal crisis consisting of SI with intent to die within the past week and/or a suicide attempt within the past month
- Veteran status
- ability to speak English
- ability to complete the informed consent process
- willingness/ability to attend 12 outpatient treatment sessions and 3 fMRI sessions following hospital discharge
You may not qualify if:
- significant cognitive impairment
- current psychotic or manic features
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael S Esterman, PhD
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Independent evaluators will be masked to treatment condition.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2023
First Posted
July 5, 2023
Study Start
March 3, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- As soon as feasible.
- Access Criteria
- De-identified data-sets corresponding to published papers will only be available through filing Freedom of Information Act requests to The Privacy Officer at VA Boston Healthcare System. For all other study materials, directly contact study PI.
The de-identified datasets will include all data underlying any publications generated by this study and are therefore sufficient to reproduce or verify any published findings. Data will be securely stored on a local network behind the VA firewall, in the PI's folder on an encrypted computer. Records kept in this location will also contain reference to the corresponding publication(s), completing the association between publications and corresponding datasets. De-identified data-sets corresponding to published papers will only be available through filing Freedom of Information Act requests.