Efficacy and Mechanisms of CBT4CBT for Alcohol Use Disorders
NCT ID: NCT02742246
Last Updated: 2023-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2017-02-14
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard treatment as usual (TAU)
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.
No interventions assigned to this group
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.
Individual clinician-provided CBT
Individual clinician-provided CBT
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.
CBT4CBT
CBT computer program assisted therapy
Interventions
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Individual clinician-provided CBT
Individual clinician-provided CBT
CBT4CBT
CBT computer program assisted therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Brian Kiluk, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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MCCA
Bridgeport, Connecticut, United States
SATU
New Haven, Connecticut, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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