Efficacy and Mechanisms of CBT4CBT for Alcohol Use Disorders

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

Detailed Description
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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.

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

Conditions
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Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: Individual clinician-provided CBT
* Behavioral: CBT4CBT


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard treatment as usual (TAU)<br>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. | |
| Active Comparator: Individual clinician-provided CBT<br>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<br>* Individual clinician-provided CBT<br>|
| Experimental: CBT4CBT<br>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<br>* CBT computer program assisted therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |