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A Stage I Study of Computer Based Training in CBT for Alcohol Use Disorders

$189,703R21FY2013AANIH

Yale University, New Haven CT

Investigators

Linked publications, trials & patents

Abstract

DESCRIPTION (provided by applicant): Computer-assisted treatments have tremendous potential for making evidence based therapies more widely available to those who may benefit from them, standardizing treatment delivery, extending and freeing up the time of busy clinicians, and reducing the costs of treatment. Despite their enormous promise, however, well- controlled randomized clinical trials of computer-assisted therapies remain rare, and there are fewer still that would meet established methodological standards for the evaluation of clinician-delivered behavioral therapies. We have developed a computer-assisted version of CBT (CBT4CBT) and have demonstrated its efficacy, durability, and specificity as an adjunct to outpatient treatment for illicit drug dependence. In 2009, we were approached by NIAAA to develop a web-based version of CBT4CBT specifically for individuals with alcohol use disorders, as there are no existing full-scale computer-assisted CBT programs for alcohol use disorders with demonstrated efficacy. Funded through ARRA, development of the web based CBT4CBT alcohol program was completed in 2011, within our specified timeline. We now propose an exploratory, Stage I study to evaluate the program's feasibility and preliminary efficacy with treatment-seeking alcohol dependent individuals. We propose to conduct an 8-week randomized clinical trial with 90 treatment-seeking individuals meeting current criteria for alcoho dependence. Participants will be randomized to one of three conditions: (1) standard outpatient counseling, (2) counseling plus CBT4CBT (the website delivered as an add-on to standard counseling, or (3) web-based CBT4CBT as a virtual standalone (CBT4CBT plus minimal clinical monitoring). This design is novel for a Stage 1 study in that it will allow evaluation of the program in two of the forms in which it is most likely to be implemented clinically (add-on and stand alone). The primary outcome measures will be reduction in alcohol use (percent days abstinent, heavy drinking days by week). Measures of treatment utilization and other secondary outcomes will be used to evaluate whether web-based CBT4CBT retains key characteristics of traditional clinician-delivered CBT (e.g., acquisition of coping skills, use of change strategies).

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