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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
Summary
This trial is testing a novel intervention that uses smartphones to reduce suicide risk in Veterans with serious mental illness by targeting their emotion awareness and social functioning.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 weeks, 8 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 8 weeks.
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)
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Affective AwarenessExperimental Treatment1 Intervention
Intervention involving psychoeducation and daily emotion awareness practices
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,360,030 Total Patients Enrolled
17 Trials studying Bipolar Disorder
2,546 Patients Enrolled for Bipolar Disorder
David Kimhy, PhDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
2 Previous Clinical Trials
132 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with PTSD.I have been diagnosed with schizophrenia.
Research Study Groups:
This trial has the following groups:- Group 1: Affective Awareness
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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