Intervention for suicide risk in veterans with serious mental illness
Alexithymia Intervention for Suicide (ALEXIS)
PHASE1 · VA Office of Research and Development · NCT05724953
This study is testing a new program that uses education and mobile technology to help veterans with serious mental illness improve their emotional awareness and social skills to reduce their risk of suicide.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 1 site (Bronx, New York) |
| Trial ID | NCT05724953 on ClinicalTrials.gov |
What this trial studies
This study aims to address the high suicide rates among veterans with serious mental illness by testing a novel intervention that combines psychoeducation and mobile health technology. The intervention focuses on improving emotion awareness and social functioning, which are critical for reducing suicide risk. Participants will be veterans diagnosed with conditions such as PTSD, bipolar disorder, major depressive disorder, or schizophrenia, who also exhibit limited emotion awareness. The study will assess the feasibility and acceptability of this blended approach to enhance emotional and social skills.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans diagnosed with PTSD, bipolar disorder, major depressive disorder, or schizophrenia who are at risk of suicide and have limited emotion awareness.
Not a fit: Patients with medical or neurological conditions that could interfere with study participation or those currently enrolled in another treatment study may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce suicide risk among veterans with serious mental illness by improving their emotional awareness and social functioning.
How similar studies have performed: While there is emerging evidence linking emotion awareness to social functioning and suicide risk, this specific approach combining psychoeducation and mobile health technology is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * a DSM-V diagnosis of PTSD * bipolar disorder * MDD * schizophrenia * at risk of suicide(Columbia Suicide Severity Rating Scale * C-SSRS \>=3 or a suicide attempt in the past 5 years) * limited emotion awareness (Toronto Alexithymia Scale; TAS-20 \>=52) * can understand all the study's risks and benefits Exclusion Criteria: * have medical/neurological conditions that could interfere with study participation * enrolled in another treatment study * unable/unwilling to provide a verifiable contact for emergency purposes
Where this trial is running
Bronx, New York
- James J. Peters VA Medical Center, Bronx, NY — Bronx, New York, United States (RECRUITING)
Study contacts
- Principal investigator: David Kimhy, PhD — James J. Peters Veterans Affairs Medical Center
- Study coordinator: David Kimhy, PhD
- Email: David.Kimhy@va.gov
- Phone: (718) 584-9000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Suicide, Schizophrenia, Bipolar Disorder, Post Traumatic Stress Disorder, Major Depressive Disorder