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

Not Applicable

Completed

• Conditions: CBT Decoupling; CBT Anxiety Reduction; CBT Combined
• Interventions: Behavioral: De-coupling; Behavioral: Combined; Behavioral: Anxiety Reduction

• Registration Number: NCT02161211
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2014-06-09
• Study First Submitted QC: 2014-06-10
• Study First Posted: 2014-06-11
• Study Start: 2014-07
• Primary Completion: 2020-02-19
• Study Completion: 2020-06-19
• Results First Submitted: 2022-02-25
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-18
• Last Update Submitted: 2022-05-18
• Results First Posted: 2023-02-15
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
De-coupling	De-coupling	Six sessions of CBT for anxiety-alcohol de-coupling
Combined	Combined	Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each.
Anxiety Reduction	Anxiety Reduction	Six sessions of CBT for anxiety reduction.

Primary Outcome Measures

Name	Time	Method
Number of Participants That Relapsed to Drinking at 4 Months	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	4-months	Negative binomial regression with offset for possible drinking days exposure in 4 months post treatment
Number of Standard Drinks Per Drinking Day	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 Outcome Measures

Name	Time	Method
Number of Participants Who Met SCID-IV Criteria for Alcohol Dependence at 4 Months	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
Number of Participants Who Relapsed to Hazardous Drinking	4 months	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

Trial Locations

Locations (1)

Lodging Plus Program, Fairview Hospital; 🇺🇸 Minneapolis, Minnesota, United States