Web-based CBT4CBT for Alcohol (CBT4CBT Etoh)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01615497
First received: June 6, 2012
Last updated: September 11, 2014
Last verified: September 2014

June 6, 2012
September 11, 2014
November 2012
June 2015   (final data collection date for primary outcome measure)
Reduction in alcohol use [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01615497 on ClinicalTrials.gov Archive Site
Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Web-based CBT4CBT for Alcohol
Computer Based Training in Cognitive Behavioral Therapy Web-based Delivery of CBT4CBT for Alcohol

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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Alcohol Abuse or Dependence
  • Behavioral: Standard Treatment as Usual (TAU)
    Treatment normally offered at this clinic which could include individual or group alcohol and drug counseling sessions one time per week lasting one hour each time.
  • Behavioral: Web-based CBT4CBT for alcohol plus TAU
    Subjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus TAU
  • Behavioral: Web-based CBT with minimal clinical contact
    Subjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus 10 minute check in with clinician.
  • Active Comparator: Standard Treatment as Usual (TAU)
    Treatment that would normally be received at the clinic typically consisting of individual or group counseling sessions focusing on alcohol and substance abuse.
    Intervention: Behavioral: Standard Treatment as Usual (TAU)
  • Experimental: Web-based CBT4CBT for alcohol plus TAU
    A computerized program that teaches skills for stopping drug and alcohol use by increasing coping skills such as how to understand patterns of drug use, coping with cravings, etc. plus standard treatment as usual.
    Intervention: Behavioral: Web-based CBT4CBT for alcohol plus TAU
  • Active Comparator: Web-based CBT with minimal clinical contact
    A computerized program that teaches skills for stopping drug and alcohol use by increasing coping skills such as how to understand patterns of drug and alcohol use, coping with cravings, etc. plus 10 minute check in with clinician.
    Intervention: Behavioral: Web-based CBT with minimal clinical contact
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Kathleen Devore, BA 203-974-5733 kathleen.devore@yale.edu
Contact: Matthew Buck, BS 203-974-5732 matthew.buck@yale.edu
United States
 
NCT01615497
1204010157
Yes
Yale University
Yale University
National Institute on Drug Abuse (NIDA)
Principal Investigator: Kathleen Carroll, PhD Yale University
Yale University
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP