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

May 18, 2022 updated by: University of Minnesota
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • Lodging Plus Program, Fairview Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 month follow-up
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
4-months
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
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
Time Frame: 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
Time Frame: 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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2014

Primary Completion (Actual)

February 19, 2020

Study Completion (Actual)

June 19, 2020

Study Registration Dates

First Submitted

June 9, 2014

First Submitted That Met QC Criteria

June 10, 2014

First Posted (Estimate)

June 11, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

May 18, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSYCH-2016-22016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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