Recruiting
Phase 2

Observational Study

Sponsor:

VA Office of Research and Development

Code:

NCT05931289

Conditions

Suicide

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enhanced Crisis Response Planning (ECRP)

Brief Cognitive Behavioral Therapy for Suicide Prevention (BCBT)

Study Details

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.

Conditions

Suicide

Study ID

NCT05931289

Start date

Mar 3, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • significant cognitive impairment
  • current psychotic or manic features

Study Design

Enrollment

136 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Enhanced Crisis Response Planning

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.

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.

Interventions

Enhanced Crisis Response Planning (ECRP)

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.

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 and Locations

Central contacts

Michael S Esterman, PhD

(857) 364-4362Michael.Esterman@va.gov

Locations

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Recruiting

Boston, Massachusetts, United States, 02130-4817

Contacts

Michael S Esterman, PhD

857-364-4362Michael.Esterman@va.gov

Principal Investigator:

Michael S Esterman, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Suicide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-02-17.