Computer-Based Training in Cognitive Behavior Therapy (CBT4CBT)

This study has been completed.

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Yale University

ClinicalTrials.gov Identifier:

NCT00350610

First received: July 7, 2006

Last updated: January 28, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 7, 2006

Last Updated Date

January 28, 2013

Start Date ^ICMJE

November 2007

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

reduction in drug use
retention in treatment

Change History

Complete list of historical versions of study NCT00350610 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

patients ability to demonstrate coping skills through a role-playing evaluation

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Computer-Based Training in Cognitive Behavior Therapy

Official Title ^ICMJE

Computer-Based Training in Cognitive Behavior Therapy

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cocaine Abuse

Intervention ^ICMJE

Other: Treatment as usual (TAU)
Standard treatment as usual in a community based treatment setting
Behavioral: CBT for CBT
Standard treatment as usual (TAU) plus computer based therapy using CBT

Study Arm (s)

Active Comparator: 1
Standard treatment as usual (TAU) in a community based clinic consisting of individual and group therapy sessions and regular urine monitoring.

Intervention: Other: Treatment as usual (TAU)
Experimental: 2
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.
Interventions:
- Other: Treatment as usual (TAU)
- Behavioral: CBT for CBT

Publications *

Carroll KM, Kiluk BD, Nich C, Babuscio TA, Brewer JA, Potenza MN, Ball SA, Martino S, Rounsaville BJ, Lejuez CW. Cognitive function and treatment response in a randomized clinical trial of computer-based training in cognitive-behavioral therapy. Subst Use Misuse. 2011;46(1):23-34.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

December 2012

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00350610

Other Study ID Numbers ^ICMJE

0207017894, DA015969

Has Data Monitoring Committee

Yes

Responsible Party

Yale University

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

National Institute on Drug Abuse (NIDA)

Investigators ^ICMJE

Principal Investigator:

Kathleen Carroll, PhD

Yale University/Department of Psychiatry

Information Provided By

Yale University

Verification Date

January 2013

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

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