Computer Based Training in Cognitive Behavioral Therapy Web-based (Man VS Machine)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Yale University
Information provided by (Responsible Party):
Yale University Identifier:
First received: September 26, 2011
Last updated: January 15, 2016
Last verified: January 2016
The investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT program to evaluate its effectiveness relative to standard outpatient counseling at 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
Substance Abuse
Behavioral: Standard Treatment As Usual (TAU)
Behavioral: Individual clinician-provided CBT
Behavioral: CBT4CBT
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

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Reduction in drug abuse [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjects ability to demonstrate coping skills through a computerized role-playing evaluation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Individual clinician-provided CBT
Individual treatment provided by a trained Cognitive Behavioral Therapy (CBT)clinician who will cover the same skills provided by the CBT4CBT computer program.
Behavioral: Individual clinician-provided CBT
Individual drug counseling sessions with trained clinicians using CBT one time per week last one hour per session.
Experimental: CBT4CBT
A computerized program that teaches skills for stopping drug use and increasing coping skills such as how to understand patterns of drug use, coping with cravings, etc.
Behavioral: CBT4CBT
Subjects work with a computerized program that teaches skills for stopping drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session.
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 substance abuse.
Behavioral: Standard Treatment As Usual (TAU)
Treatment normally offered at this clinic which could include individual or group drug counseling sessions one time per week last one hour each time.

Detailed Description:
One hundred eighty drug-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) individual clinician delivered CBT, or (3) web-based CBT4CBT. Treatments will be delivered over a 12-week period with a six-month follow-up after termination of the study treatments. The primary outcome measures will be reduction in substance use (frequency of drug use by time, confirmed by urine toxicology screens). 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.

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 cocaine, marijuana,opioid,or amphetamine dependence.
  • Are sufficiently stable for 12 weeks of outpatient treatment.
  • Can commit to 12 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 12-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 identifier: NCT01442597

Contact: Matthew Buck, BS 203-974-5732
Contact: Kathleen Devore, BA 203-974-5733

United States, Connecticut
Substance Abuse Treatment Unit (SATU) Recruiting
New Haven, Connecticut, United States, 06510
Contact: Liz Vollono, MSW    203-974-5732   
Sub-Investigator: Brian Kiluk, PhD         
Sponsors and Collaborators
Yale University
Principal Investigator: Kathleen Carroll, PhD Yale University
  More Information

Responsible Party: Yale University Identifier: NCT01442597     History of Changes
Other Study ID Numbers: 1004006632 
Study First Received: September 26, 2011
Last Updated: January 15, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
cognitive behavior therapy
computer assisted instruction
drug abuse therapy
educational resource design and development processed this record on May 23, 2016