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OpenTrials
Completed

NCT Number: NCT02742246

Efficacy and Mechanisms of CBT4CBT for Alcohol Use Disorders

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MCCA, Bridgeport, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Individual clinician-provided CBT

Behavioral

Individual clinician-provided CBT

CBT4CBT

Behavioral

CBT computer program assisted therapy

Primary outcomes

  1. Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back

    Time frame: 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.

  2. Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 18, 2016
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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