Web-based CBT4CBT for Alcohol (CBT4CBT Etoh)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kathleen M. Carroll, Yale University
ClinicalTrials.gov Identifier:
NCT01615497
First received: June 6, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Alcohol Abuse or Dependence
Behavioral: Standard Treatment as Usual (TAU)
Behavioral: Web-based CBT4CBT for alcohol plus TAU
Behavioral: Web-based CBT with minimal clinical contact
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Computer Based Training in Cognitive Behavioral Therapy Web-based Delivery of CBT4CBT for Alcohol

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Reduction in alcohol use [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: November 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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
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.
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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615497

Contacts
Contact: Kathleen Devore, BA 203-974-5733 kathleen.devore@yale.edu
Contact: Matthew Buck, BS 203-974-5732 matthew.buck@yale.edu

Locations
United States, Connecticut
Substance Abuse Treatment Unit (SATU) Recruiting
New Haven, Connecticut, United States, 06519
Contact: kathleen Devore, BA    203-974-5733    kathleen.devore@yale.edu   
Contact: Matthew Buck, BS    203-974-5732    matthew.buck@yale.edu   
Sub-Investigator: Brian Kiluk, PhD         
Substance Abuse Treatment Unit (SATU) Recruiting
New Haven, Connecticut, United States, 06511
Sub-Investigator: Brian Kiluk, PhD         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Kathleen Carroll, PhD Yale University
  More Information

No publications provided

Responsible Party: Kathleen M. Carroll, Professor, Yale University
ClinicalTrials.gov Identifier: NCT01615497     History of Changes
Other Study ID Numbers: 1204010157
Study First Received: June 6, 2012
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
cognitive behavior therapy
computer assisted instruction
alcohol abuse therapy
educational resource design and development

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014