Efficacy and Mechanisms of CBT4CBT for Alcohol Use Disorders

Not Applicable

Completed

• Conditions: Alcohol Use Disorder
• Interventions: Behavioral: Individual clinician-provided CBT; Behavioral: CBT4CBT

• Registration Number: NCT02742246
• Lead Sponsor: Yale University

Brief Summary

Evaluate the efficacy of CBT4CBT and clinician-delivered CBT relative to standard treatment for reducing alcohol use

Detailed Description

Evaluate the efficacy of Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) and clinician-delivered Cognitive Behavioral Therapy (CBT) relative to standard treatment for reducing alcohol use through an 8-week randomized trial with 6-month follow-up. Our primary hypothesis is that either form of CBT will be more effective than standard treatment at increasing the percentage of days abstinent during treatment (8 weeks) and through the follow-up (6 months), assessed via Timeline FollowBack interviews.

Study Timeline

• Study First Submitted: 2016-04-08
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-18
• Study Start: 2017-02-14
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Results First Submitted: 2022-12-22
• Results First Submitted QC: 2023-03-02
• Results First Posted: 2023-03-28
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Individuals will be included who:

• Are 18 years of age or older.
• Are applying for outpatient alcohol treatment and meet current DSM-5 criteria for alcohol use disorder, consuming at least 14/7 drinks (men/women) per week with at least 4 heavy drinking days reported in the past 28 days,
• Are sufficiently stable for 8 weeks of outpatient treatment and can commit to a 6-month follow-up
• Are willing to provide locator information for follow-up, and
• Are fluent in English and have a 6th grade or higher reading level.

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Exclusion Criteria

Individuals will be excluded who:

• Have an untreated bipolar or schizophrenic disorder,
• Have a current legal case pending such that incarceration during the 8-week protocol is likely,
• Have been prescribed an alcohol pharmacotherapy (e.g., disulfiram, naltrexone) within the past two weeks, or
• Are physically dependent on alcohol, opioids or benzodiazepines such that immediate medical detoxification is necessary for safety purposes (individuals demonstrating significant withdrawal symptoms would be eligible for re-screening following brief medical detoxification, which is arranged by RCS staff at triage).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual clinician-provided CBT	Individual clinician-provided CBT	This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
CBT4CBT	CBT4CBT	In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.

Primary Outcome Measures

Name	Time	Method
Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back	Baseline up to 8 weeks	The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure alcohol use over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use.
Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back	from end of treatment at week 8 up to 6 months	The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure change over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use summarized monthly.

Trial Locations

Locations (2)

MCCA; 🇺🇸 Bridgeport, Connecticut, United States

SATU; 🇺🇸 New Haven, Connecticut, United States