NCT05724953|TerminatedPhase 1
Study Stopped
Staff turnover and trouble with recruitment, staffing, and paying invoices.
Alexithymia Intervention for Suicide
ALEXIS
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Sponsor study identifier
interventional
11
1 country
1
Study Start
October 1, 2023
Actual (reported)Primary Completion
January 30, 2026
Actual (reported)Study Completion
January 30, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2026
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2023
Actual (reported)February 13, 2023
Actual (reported)October 1, 2023
Actual (reported)January 30, 2026
Actual (reported)January 30, 2026
Actual (reported)Columbia Suicide Severity Rating Scale (C-SSRS) Change
A semi-structured interview indexing suicide risk and related domains including ideation, severity, intensity, behavior, and lethality.
Baseline, 6 weeks, 8 weeks.
Toronto Alexithymia Scale (TAS-20) Change
A self-report scale indexing difficulty identifying, difficulty describing feelings, and externally oriented thinking.
Baseline, 6 weeks, 8 weeks.
Provision of Social Relations Scale (PSRS) Change
A self-report scale indexing relationship with family and friends.
Baseline, 6 weeks, 8 weeks.
Intervention involving psychoeducation and daily emotion awareness practices
Intervention involving psychoeducation and daily emotion awareness practices
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468-3904, United States
Marianne S. Goodman, MD
James J. Peters Veterans Affairs Medical Center
11 participants (actual enrollment reported by the registry).
First Submitted
February 1, 2023
First Posted
February 13, 2023
Study Start
October 1, 2023
Emotion Granularity Index Change
Baseline, 6 weeks, 8 weeks.
MIRECC-GAF Change
Baseline, 6 weeks, 8 weeks.
World Health Organization Quality of Life - Brief (WHOQOL-BREF) Change
Baseline, 6 weeks, 8 weeks.
Emotion Regulation Questionnaire (ERQ) Change
Baseline, 6 weeks, 8 weeks.
Contact the study team to confirm eligibility.
Primary Completion
January 30, 2026
Actual (reported)Study Completion
January 30, 2026
Actual (reported)Last Updated
March 27, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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