NCT05724953TerminatedPhase 1
Alexithymia Intervention for Suicide
Alexithymia Intervention for Suicide (ALEXIS)
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Reason given: Staff turnover and trouble with recruitment, staffing, and paying invoices.
Brief summary (registry, in English)
Suicide rates among Veterans with Serious Mental Illness (SMI) are intractably high, representing a serious public health concern and a critical target for interventions. Yet, at present available treatments offer modest benefits. Thus, there remains an urgent need to identify novel approaches to address suicide risk in this population. Previous reports have linked suicide risk with poor social functioning. Emerging evidence from basic affective neuroscience research has indicated that effective social functioning is contingent on intact emotion awareness. Consistent with these findings, individuals with SMI at risk of suicide display social functioning difficulties along with poor emotion awareness (i.e., alexithymia). Employing a proof-of-concept design, the aim of the present study is to test the feasibility and acceptability of a novel, blended psychoeducation and digital mHealth (mobile health) intervention with smartphones designed to target alexithymia and poor social functioning to reduce suicide risk in Veterans with SMI.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- First submitted
- 1 Feb 2023
- Start date
- 1 Oct 2023
- Primary completion date
- 30 Jan 2026
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Schizophrenia, Bipolar disorder, Depression
- NCT number
- NCT05724953
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- have medical/neurological conditions that could interfere with study participation
Other
- enrolled in another treatment study
- unable/unwilling to provide a verifiable contact for emergency purposes
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| James J. Peters VA Medical Center, Bronx, NY | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.