Dismantling the Components and Dosing of CBT for Co-Occurring Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Number of Participants That Relapsed to Drinking at 4 Months
Study Overview
Brief Summary
The purpose of this study is to establish a brief CBT intervention that can largely, if not fully eliminate the deleterious effect of common co-occurring anxiety disorders on alcohol use disorder treatment outcomes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •diagnostic and Statistical Manual IV diagnosis of panic disorder, generalized anxiety disorder, and/or social anxiety disorder within the past 30 days;
- •inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug) dependence
- •alcohol use in the 30 days preceding the study
- •ability to provide informed consent
- •minimum of a sixth grade reading level (deemed necessary to complete study materials);
- •willingness to provide contact information to confirm study follow-up appointments
- •lives within proximity to the Twin Cities (e.g., within about an hour's drive) for the purpose attending follow-up visits
Exclusion Criteria
- •lifetime history of psychosis or mania by history
- •cognitive or physical impairment that precludes study participation
- •currently and seriously suicidal (i.e., plan and intent)
Arms & Interventions
De-coupling
Six sessions of CBT for anxiety-alcohol de-coupling
Intervention: De-coupling (Behavioral)
Anxiety Reduction
Six sessions of CBT for anxiety reduction.
Intervention: Anxiety Reduction (Behavioral)
Combined
Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each.
Intervention: Combined (Behavioral)
Outcomes
Primary Outcomes
Number of Participants That Relapsed to Drinking at 4 Months
Time Frame: 4 month follow-up
Relapse status will be assessed using categorical relapse status (yes vs. no). Count is of those who relapsed
Number of Drinking Days in 4 Months Post Treatment
Time Frame: 4-months
Negative binomial regression with offset for possible drinking days exposure in 4 months post treatment
Number of Standard Drinks Per Drinking Day
Time Frame: 4 months
Drinks per drinking day among those who relapsed by 4 months. Standard Drink is defined as 12oz beer, 4ox wine, 3oz fortified wine, 1oz hard liquor
Secondary Outcomes
- Number of Participants Who Met SCID-IV Criteria for Alcohol Dependence at 4 Months(4 months)
- Number of Participants Who Relapsed to Hazardous Drinking(4 months)