| NCT ID | NCT05931289 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VA Office of Research and Development |
| Condition | Suicide |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 136 participants in total. It began in 2025-03-03 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Michael S Esterman, PhD
PRINCIPAL INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Frequently Asked Questions
Who can join the NCT05931289 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Suicide. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05931289 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05931289 currently recruiting?
Yes, NCT05931289 is actively recruiting participants. Contact the research team at Michael.Esterman@va.gov for enrollment information.
Where is the NCT05931289 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05931289 clinical trial?
NCT05931289 is sponsored by VA Office of Research and Development. The principal investigator is Michael S Esterman, PhD at VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA. The trial plans to enroll 136 participants.