Clinical trial NCT01615497: Web-based CBT4CBT for Alcohol
Official title: Computer Based Training in Cognitive Behavioral Therapy Web-based Delivery of CBT4CBT for Alcohol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Abuse or Dependence
Keywords: cognitive behavior therapy
computer assisted instruction
alcohol abuse therapy
educational resource design and development
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2012-06-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) program specifically designed for alcohol to evaluate its effectiveness relative to standard outpatient counseling at the Substance Abuse Treatment Unit (SATU). The computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.

Detailed description: Ninety alcohol using individuals seeking treatment at the Substance Abuse Treatment Unit (SATU) of the Connecticut Mental Health Center will be randomized to (1) standard outpatient counseling at SATU (typically consisting of weekly group counseling), (2) standard outpatient counseling plus web-based CBT, or (3) web-based CBT4CBT with minimal clinical monitoring. Treatments will be delivered over an 8-week period with a six-month follow-up after termination of the study treatments. The primary outcome measures will be reduction in alcohol use (frequency of alcohol use by time, confirmed by urine toxicology screens and breathalyzers). Secondary outcomes will include treatment utilization and cost, several measures intended to detect whether web-based CBT4CBT retains key characteristics of traditional clinician-administered CBT (e.g., acquisition of coping skills, use of change strategies), participant characteristics which will be evaluated as potential moderators of outcome, as well as participant satisfaction and treatment credibility.

Eligibility criteria: Inclusion Criteria:

* Are 18 years of age or older.
* Are applying for outpatient, non-agonist substance abuse treatment at SATU.
* Meet current DSM-IV criteria for alcohol abuse or dependence.
* Are sufficiently stable for 8 weeks of outpatient treatment.
* Can commit to 8 weeks of treatment and are willing to be randomized to treatment
* Are willing to provide locator information for follow-up.
* Are fluent in English and have a 6th grader or higher reading level

Exclusion Criteria:

* Have an untreated bipolar or schizophrenic disorder.
* Who have a current legal case pending such that incarceration during 8-week protocol is likely.
* Are physically dependent on alcohol, opioids or benzodiazepines

Primary outcomes:
measure: Reduction in alcohol use
timeFrame: 8 weeks
Secondary outcomes:
measure: Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Substance Abuse Treatment Unit (SATU)
state: Connecticut
city: New Haven
country: United States
facility: Substance Abuse Treatment Unit (SATU)
state: Connecticut
Study officials:
affiliation: Yale University
name: Kathleen Carroll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiluk BD, Devore KA, Buck MB, Nich C, Frankforter TL, LaPaglia DM, Yates BT, Gordon MA, Carroll KM. Randomized Trial of Computerized Cognitive Behavioral Therapy for Alcohol Use Disorders: Efficacy as a Virtual Stand-Alone and Treatment Add-On Compared with Standard Outpatient Treatment. Alcohol Clin Exp Res. 2016 Sep;40(9):1991-2000. doi: 10.1111/acer.13162. Epub 2016 Aug 4.