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Behavioral Intervention

Affective Awareness for Suicide Prevention (ALEXIS Trial)

Phase 1
Recruiting
Led By David Kimhy, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline.
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new approach to help veterans with serious mental illness who are at risk of suicide. The treatment combines group education sessions and a smartphone app to improve emotional awareness and social functioning. By helping veterans understand their emotions better, the goal is to reduce their suicide risk.

Who is the study for?
This trial is for Veterans with serious mental illnesses like PTSD, bipolar disorder, schizophrenia, and depression who are at risk of suicide. Participants must have limited emotion awareness and understand the study's risks and benefits. Those with certain medical conditions or involved in another treatment study cannot join.
What is being tested?
The trial is testing a new intervention combining psychoeducation with digital mHealth tools to improve emotion awareness and social functioning, aiming to reduce suicide risk among Veterans with serious mental illness.
What are the potential side effects?
Since this intervention involves psychoeducation and use of digital tools rather than medication, typical drug side effects are not expected. However, participants may experience emotional discomfort or distress when discussing sensitive topics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 8 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 8 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Columbia Suicide Severity Rating Scale (C-SSRS) Change
Provision of Social Relations Scale (PSRS) Change
Toronto Alexithymia Scale (TAS-20) Change
Secondary study objectives
Emotion Granularity Index Change
Other study objectives
Beck Anxiety Inventory (BAI) Change
Beck Depression Inventory (BDI) Change
Childhood Trauma Questionnaire (CTQ)
+8 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Affective AwarenessExperimental Treatment1 Intervention
Intervention involving psychoeducation and daily emotion awareness practices

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,668 Previous Clinical Trials
3,765,826 Total Patients Enrolled
David Kimhy, PhDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
2 Previous Clinical Trials
132 Total Patients Enrolled

Media Library

Affective Awareness (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05724953 — Phase 1
Self-Harm Research Study Groups: Affective Awareness
Self-Harm Clinical Trial 2023: Affective Awareness Highlights & Side Effects. Trial Name: NCT05724953 — Phase 1
Affective Awareness (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05724953 — Phase 1
~7 spots leftby Mar 2025
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