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

NCT02161211 | Completed Results DMC

• 1 other identifier: PSYCH-2016-22016
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

CBT Decoupling; CBT Anxiety Reduction; CBT Combined

Keywords

alcohol; anxiety

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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 Arms (3)

De-coupling

EXPERIMENTAL

Six sessions of CBT for anxiety-alcohol de-coupling

Behavioral: De-coupling

Anxiety Reduction

EXPERIMENTAL

Six sessions of CBT for anxiety reduction.

Behavioral: Anxiety Reduction

Combined

EXPERIMENTAL

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

Behavioral: Combined

Interventions

De-coupling BEHAVIORAL

Six sessions of CBT for anxiety-alcohol de-coupling

De-coupling

Anxiety Reduction BEHAVIORAL

Six sessions of CBT for anxiety reduction.

Anxiety Reduction

Combined BEHAVIORAL

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

Combined

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Lodging Plus Program, Fairview Hospital

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Matt Kushner, Ph.D.
• Organization: University of Minnesota

kushn001@umn.edu

612-625-7546

Study Officials

• Matt Kushner, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 11, 2014
• Study Start: July 1, 2014
• Primary Completion: February 19, 2020
• Study Completion: June 19, 2020
• Last Updated: February 15, 2023
• Results First Posted: February 15, 2023

Record last verified: 2022-05

Locations

US (1)