Efficacy and Mechanisms of CBT4CBT for Alcohol Use Disorders
- Study HIC#:1511016759
- Last Updated:07/15/2021
Evaluate the efficacy of CBT4CBT and clinician-delivered CBT relative to standard treatment for reducing alcohol use
- Age18 years and older
- Start Date01/30/2017
- End Date07/31/2021
Trial Purpose and Description
Well-controlled randomized clinical trials of computer-assisted therapies are very rare, and there are few that would meet current methodological standards established for traditional evidence-based treatments. We propose to conduct a randomized clinical trial of our web-based version of Computer Based Training in Cognitive Behavioral Therapy (CBT4CBT) to evaluate its effectiveness relative to therapist-delivered cognitive behavioral therapy or standard outpatient counseling with participants with alcohol use disorder. Specific aims are as follows:
Aim 1 ¿ Evaluate the efficacy of CBT4CBT and clinician-delivered 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 (PDA)2, 3 during treatment (8 weeks) and through the follow-up (6 months), assessed via Timeline FollowBack interviews. Secondary outcomes will include percentage of heavy drinking days (PHDD), urine ethyl glucoronide analysis (EtG), drinking-related consequences, quality of life, and cost effectiveness.
Aim 2 ¿ Evaluate the extent to which CBT¿s putative mechanisms act as mediator of treatment effect on reducing alcohol use in both forms of CBT relative to standard treatment. Hypothesized mechanisms include enhanced behavioral, cognitive, and affective control, measured within treatment by indices reflecting acquisition and implementation of targeted skills (behavioral role-play assessment, coping strategies inventory, and measures of homework completion and knowledge of CBT). Latent growth curve modeling will test for mediation using the product of coefficients method. We hypothesize:
(a) greater increases in skills acquisition for those assigned to either form of CBT compared to TAU;
(b) increased acquisition of skills during treatment will be associated with greater PDA during follow-up;
(c) CBT¿s effect (in either delivery format) on PDA will be mediated by skills acquisition.
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.
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 benzodiazepenes 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).