Efficacy and Mechanisms of CBT4CBT for Alcohol Use Disorders

Alcohol Use Disorder Clinical Trial

Official title:

Efficacy and Mechanisms of Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) for Alcohol Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742246
• Other study ID #: 1511016759
• Secondary ID: 1R01AA024122-01A
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2023
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. 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).

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Individual clinician-provided CBT
Individual clinician-provided CBT
• CBT4CBT
CBT computer program assisted therapy

Locations

Country	Name	City	State
United States	MCCA	Bridgeport	Connecticut
United States	SATU	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back	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.	Baseline up to 8 weeks
Primary	Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back	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.	from end of treatment at week 8 up to 6 months