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Clinical Trials/NCT02161211
NCT02161211
Completed
Not Applicable

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

University of Minnesota1 site in 1 country300 target enrollmentJuly 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
CBT Decoupling
Sponsor
University of Minnesota
Enrollment
300
Locations
1
Primary Endpoint
Number of Participants That Relapsed to Drinking at 4 Months
Status
Completed
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
June 19, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

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)

Study Sites (1)

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