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Computer-Based Training in Cognitive Behavior Therapy (CBT4CBT)
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), November 2008
Sponsored by: National Institute on Drug Abuse (NIDA)
Information provided by: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00350610
  Purpose

The computer-based training program (CBT for CBT) 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
Cocaine Abuse
Other: Treatment as usual (TAU)
Behavioral: CBT for CBT
Phase I

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Computer-Based Training in Cognitive Behavior Therapy

Further study details as provided by National Institute on Drug Abuse (NIDA):

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

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

Estimated Enrollment: 120
Study Start Date: November 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: No Intervention
Standard treatment as usual (TAU) in a community based clinic consisting of individual and group therapy sessions and regular urine monitoring.
Other: Treatment as usual (TAU)
Standard treatment as usual in a community based treatment setting
2: Experimental
Standard treatment as usual (TAU) plus coping skills computer program. In addition to the individual and group therapy sessions (TAU), individuals will work with a computerized program that teaches skills for stopping cocaine use and increasing coping skills twice weekly for 8 weeks.
Behavioral: CBT for CBT
Standard treatment as usual (TAU) plus computer based therapy using CBT

Detailed Description:

In this behavioral trial 120 methadone maintained cocaine abusing individuals will be randomly assigned to either treatment as usual in a community-based clinic OR treatment as usual plus 8 hours of access to the 'CBT for CBT' computer program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in cocaine use (percent days abstinent, confirmed by urine toxicology screens). The patients' ability to demonstrate coping skills through a computerized role-play evaluation will be a secondary outcome. A six-month follow-up will assess durability and/or delayed emergence of effects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 years and older
  • methadone maintained for at least 3 months
  • meet current DSM-IV criteria for cocaine use disorder
  • fluent in English or at least a6th grade reading level
  • can commit to at least 8 weeks of treatment and willing to be randomized to treatment

Exclusion Criteria:

  • untreated bipolar or schizophrenic disorder
  • current legal case pending (pending incarceration during 8 weeks of study)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350610

Contacts
Contact: Norma Couvertier 203-781-4695 ncouvertier@aptfoundation.org

Locations
United States, Connecticut
APT Foundation Orchard Hill Clinic Recruiting
New Haven, Connecticut, United States, 06516
Contact: Norma Couvertier     203-781-4695     ncouvertier@aptfoundation.org    
Contact: Galina Portnoy, BS     203-386-8802 ext 114     gportnoy@abhct.com    
Principal Investigator: Kathleen M Carroll, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Kathleen Carroll, PhD Yale University/Department of Psychiatry
  More Information

Responsible Party: Yale University ( Kathleen Carroll, PhD )
Study ID Numbers: DA015969
Study First Received: July 7, 2006
Last Updated: November 26, 2008
ClinicalTrials.gov Identifier: NCT00350610  
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
cognitive behavior therapy
computer assisted instruction
drug abuse therapy
educational resource design and development

Study placed in the following topic categories:
Cocaine-Related Disorders
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 14, 2009