Efficacy and Mechanisms of CBT4CBT for Alcohol Use Disorders

NCT02742246 | Completed Results DMC

• 3 other identifiers: 15110167591R01AA024122-01A11K02AA027300-01A1
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Standard treatment as usual (TAU)

NO INTERVENTION

This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as teaching about the treatment program, teaching important ideas about recovery, increasing knowledge about specific problems participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. 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.

Individual clinician-provided CBT

ACTIVE COMPARATOR

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.

Behavioral: Individual clinician-provided CBT

CBT4CBT

EXPERIMENTAL

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.

Behavioral: CBT4CBT

Interventions

Individual clinician-provided CBT BEHAVIORAL

Individual clinician-provided CBT

Individual clinician-provided CBT

CBT4CBT BEHAVIORAL

CBT computer program assisted therapy

CBT4CBT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

MCCA

Bridgeport, Connecticut, 06604, United States

Location

SATU

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

• Kiluk BD, Benitez B, DeVito EE, Frankforter TL, LaPaglia DM, O'Malley SS, Nich C. A Digital Cognitive Behavioral Therapy Program for Adults With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2435205. doi: 10.1001/jamanetworkopen.2024.35205.

  PMID: 39325452 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Brian Kiluk, Associate Professor of Psychiatry
• Organization: Yale University School of Medicine

Brian.kiluk@yale.edu

203-737-1544

Study Officials

• Brian Kiluk, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2016
• First Posted: April 18, 2016
• Study Start: February 14, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 18, 2023
• Results First Posted: March 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)