Dismantling the Components and Dosing of CBT for Co-Occurring Disorders

Study Overview
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Brief Summary
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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.

Official Title
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Dismantling the Components and Dosing of CBT for Co-Occurring Disorders

Conditions
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CBT Decoupling, CBT Anxiety Reduction, CBT Combined

Intervention / Treatment
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* Behavioral: De-coupling
* Behavioral: Anxiety Reduction
* Behavioral: Combined


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: De-coupling<br>Six sessions of CBT for anxiety-alcohol de-coupling | Behavioral: De-coupling<br>* Six sessions of CBT for anxiety-alcohol de-coupling<br>|
| Experimental: Anxiety Reduction<br>Six sessions of CBT for anxiety reduction. | Behavioral: Anxiety Reduction<br>* Six sessions of CBT for anxiety reduction.<br>|
| Experimental: Combined<br>Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each. | Behavioral: Combined<br>* Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Relapsed to Drinking at 4 Months | Relapse status will be assessed using categorical relapse status (yes vs. no). Count is of those who relapsed | 4 month follow-up | 
| Number of Drinking Days in 4 Months Post Treatment | Negative binomial regression with offset for possible drinking days exposure in 4 months post treatment | 4-months | 
| Number of Standard Drinks Per Drinking Day | 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 | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Met SCID-IV Criteria for Alcohol Dependence at 4 Months | Relapse to Diagnostic and Statistical Manual (DSM)-IV alcohol dependence criteria based on Structured Clinical Interview for DSM-IV (SCID) at 4 months | 4 months | 
| Number of Participants Who Relapsed to Hazardous Drinking | Relapse to hazardous drinking (hazardous drinking is defined as 3 or more per occasion for women or more than 7 drinks per week, 4 or more per occasion for men or more than 14 drinks per week) at 4 months | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol, anxiety