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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01442597
Recruitment Status : Completed
First Posted : September 28, 2011
Last Update Posted : March 6, 2020
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Brief Summary:
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 or disease Intervention/treatment Phase
Substance Abuse Behavioral: Standard Treatment As Usual (TAU) Behavioral: Individual clinician-provided CBT Behavioral: CBT4CBT Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computer Based Training in Cognitive Behavioral Therapy Web-based
Study Start Date : January 2012
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Reduction in drug abuse [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Subjects ability to demonstrate coping skills through a computerized role-playing evaluation [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01442597

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United States, Connecticut
Substance Abuse Treatment Unit (SATU)
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Kathleen Carroll, PhD Yale University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yale University Identifier: NCT01442597    
Other Study ID Numbers: 1004006632
2P50DA009241-21 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: March 6, 2020
Last Verified: March 2020
Keywords provided by Yale University:
cognitive behavior therapy
computer assisted instruction
drug abuse therapy
educational resource design and development
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders