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Cognitive Behavioral Training for PTSD and Alcoholism

N/A
Recruiting
Research Sponsored by University of South Dakota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Severe risk for sleep apnea (a positive score in three categories of the Berlin Questionnaire), or reported treatment for sleep apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial will study how well a computerized training program works to help veterans with PTSD and AUD.

Who is the study for?
This trial is for OIF/OEF/OND veterans at risk for PTSD (with a PCL-5 score of 33 or higher) and/or AUD (AUDIT score of at least 7 for women, 8 for men). It's not suitable for individuals with active suicidal/homicidal thoughts, psychosis, severe alcohol use disorder, high risk or treatment history for sleep apnea.Check my eligibility
What is being tested?
The study examines the impact of computerized training aimed to modify harmful response tendencies and lessen the link between sleep issues, emotional and behavioral dysregulation, AUD symptoms, and PTSD symptoms in real-world settings among veterans.See study design
What are the potential side effects?
Since this trial involves computerized cognitive behavioral management (CBM) rather than medication or invasive procedures, side effects may be minimal but could include discomfort from confronting traumatic memories during PTSD CBM or frustration if tasks are challenging.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am at high risk for sleep apnea or am being treated for it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Alcohol Use Disorder Symptoms
Rate of PTSD Symptoms

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Alcohol Sham + PTSD CBMExperimental Treatment2 Interventions
Group II: Alcohol Cognitive Bias Modification (CBM) + PTSD CBMExperimental Treatment2 Interventions
Group III: Alcohol CBM + PTSD ShamExperimental Treatment2 Interventions
Group IV: Alcohol Sham + PTSD ShamPlacebo Group2 Interventions

Find a Location

Who is running the clinical trial?

Bay Pines VA Healthcare SystemFED
1 Previous Clinical Trials
Sioux Falls VA Health Care SystemFED
1 Previous Clinical Trials
1,836 Total Patients Enrolled
University of South DakotaLead Sponsor
14 Previous Clinical Trials
1,681 Total Patients Enrolled

Media Library

Alcohol CBM Clinical Trial Eligibility Overview. Trial Name: NCT04552782 — N/A
Alcoholism Research Study Groups: Alcohol Cognitive Bias Modification (CBM) + PTSD CBM, Alcohol CBM + PTSD Sham, Alcohol Sham + PTSD CBM, Alcohol Sham + PTSD Sham
Alcoholism Clinical Trial 2023: Alcohol CBM Highlights & Side Effects. Trial Name: NCT04552782 — N/A
Alcohol CBM 2023 Treatment Timeline for Medical Study. Trial Name: NCT04552782 — N/A
~43 spots leftby Apr 2025