Schizophrenia Clinical Trial
— ALEXISOfficial title:
Alexithymia Intervention for Suicide (ALEXIS)
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 | Recruiting |
Enrollment | 40 |
Est. completion date | May 30, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | James J. Peters VA Medical Center, Bronx, NY | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | MIRECC-GAF Change | A rater-based index of occupational and social functioning. | Baseline, 6 weeks, 8 weeks. | |
Other | World Health Organization Quality of Life - Brief (WHOQOL-BREF) Change | A self-report scale indexing quality of life. | Baseline, 6 weeks, 8 weeks. | |
Other | Emotion Regulation Questionnaire (ERQ) Change | A self-report scale indexing emotion regulation. | Baseline, 6 weeks, 8 weeks. | |
Other | Beck Depression Inventory (BDI) Change | A self-report scale indexing depressed mood. | Baseline, 6 weeks, 8 weeks. | |
Other | Beck Anxiety Inventory (BAI) Change | A self-report scale indexing anxiety. | Baseline, 6 weeks, 8 weeks. | |
Other | Structured Clinical Interview for DSM-V Axis I (SCID-I) | A rater-based clinical interview used to establish psychiatric diagnoses. | Baseline. | |
Other | Clinician-Administered PTSD Scale for DSM-V (CAPS-V) | A rater-based clinical interview used to assess trauma. | Baseline. | |
Other | Childhood Trauma Questionnaire (CTQ) | A self-report scale indexing childhood trauma. | Baseline. | |
Primary | 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. | |
Primary | 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. | |
Primary | Provision of Social Relations Scale (PSRS) Change | A self-report scale indexing relationship with family and friends. | Baseline, 6 weeks, 8 weeks. | |
Secondary | Emotion Granularity Index Change | An smartphone-based index of emotion granularity based on reports of emotions during daily functioning. | Baseline, 6 weeks, 8 weeks. |
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