Alexithymia Intervention for Suicide
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.
Conditions:
🦠 Suicide 🦠 Schizophrenia 🦠 Bipolar Disorder 🦠 Post Traumatic Stress Disorder 🦠 Major Depressive Disorder
🗓️ Study Start (Actual) 1 October 2023
🗓️ Primary Completion (Estimated) 31 March 2025
✅ Study Completion (Estimated) 30 May 2025
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Bronx, New York, United States

📋 Eligibility Criteria

Description

    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 year)
    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 February 2023
  • First Submitted that Met QC Criteria 10 February 2023
  • First Posted 13 February 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 October 2023
  • Last Update Posted 12 October 2023
  • Last Verified October 2023