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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
ALEXIS Trial 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.Check my eligibility
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.See study design
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.
ALEXIS Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Columbia Suicide Severity Rating Scale (C-SSRS) Change
Provision of Social Relations Scale (PSRS) Change
Toronto Alexithymia Scale (TAS-20) Change
Secondary outcome measures
Emotion Granularity Index Change
Other outcome measures
Beck Anxiety Inventory (BAI) Change
Beck Depression Inventory (BDI) Change
Childhood Trauma Questionnaire (CTQ)
+5 moreALEXIS 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
1,611 Previous Clinical Trials
3,305,244 Total Patients Enrolled
David Kimhy, PhDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
2 Previous Clinical Trials
144 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks might accompany Affective Awareness treatment?
"Given the preliminary nature of this clinical trial, Affective Awareness is assigned a safety rating of 1. This score reflects the limited data available to assess its safety and efficacy."
Answered by AI
Are there any vacancies remaining in this clinical research endeavor?
"Clinicaltrials.gov confirms that this clinical trial is not actively recruiting participants at the moment, with an original posting on April 1st 2023 and a last update occurring on February 13th of the same year. Notwithstanding, there are 2377 other trials currently searching for patient volunteers."
Answered by AI
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