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Completed

NCT Number: NCT02161211

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

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.

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Key information

Conditions

CBT Decoupling Anxiety Disorders CBT Anxiety Reduction CBT Combined Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lodging Plus Program, Fairview Hospital

Minneapolis, Minnesota, 55454, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

De-coupling

Behavioral

Six sessions of CBT for anxiety-alcohol de-coupling

Anxiety Reduction

Behavioral

Six sessions of CBT for anxiety reduction.

Combined

Behavioral

Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each.

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Acronym: CBT

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Jun 11, 2014
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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