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Computer-Based Training in Cognitive Behavior Therapy (CBT4CBT)

Primary Purpose

Cocaine Abuse

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treatment as usual (TAU)
CBT for CBT
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Abuse focused on measuring cognitive behavior therapy, computer assisted instruction, drug abuse therapy, educational resource design and development

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • APT Foundation Orchard Hill Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

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

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.

Outcomes

Primary Outcome Measures

reduction in drug use

Secondary Outcome Measures

patients ability to demonstrate coping skills through a computerized role-playing evaluation
retention in treatment

Full Information

First Posted
July 7, 2006
Last Updated
January 28, 2013
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00350610
Brief Title
Computer-Based Training in Cognitive Behavior Therapy
Acronym
CBT4CBT
Official Title
Computer-Based Training in Cognitive Behavior Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Abuse
Keywords
cognitive behavior therapy, computer assisted instruction, drug abuse therapy, educational resource design and development

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Standard treatment as usual (TAU) in a community based clinic consisting of individual and group therapy sessions and regular urine monitoring.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
Standard treatment as usual in a community based treatment setting
Intervention Type
Behavioral
Intervention Name(s)
CBT for CBT
Intervention Description
Standard treatment as usual (TAU) plus computer based therapy using CBT
Primary Outcome Measure Information:
Title
reduction in drug use
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
patients ability to demonstrate coping skills through a computerized role-playing evaluation
Time Frame
8 weeks
Title
retention in treatment
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Carroll, PhD
Organizational Affiliation
Yale University/Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
APT Foundation Orchard Hill Clinic
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30240978
Citation
DeVito EE, Kober H, Carroll KM, Potenza MN. fMRI Stroop and behavioral treatment for cocaine-dependence: Preliminary findings in methadone-maintained individuals. Addict Behav. 2019 Feb;89:10-14. doi: 10.1016/j.addbeh.2018.09.005. Epub 2018 Sep 6.
Results Reference
derived
PubMed Identifier
27658192
Citation
Decker SE, Morie K, Hunkele K, Babuscio T, Carroll KM. Emotion regulation strategies in individuals with cocaine use disorder maintained on methadone. Am J Addict. 2016 Oct;25(7):529-32. doi: 10.1111/ajad.12439. Epub 2016 Sep 22.
Results Reference
derived
PubMed Identifier
25982006
Citation
Morie KP, Nich C, Hunkele K, Potenza MN, Carroll KM. Alexithymia level and response to computer-based training in cognitive behavioral therapy among cocaine-dependent methadone maintained individuals. Drug Alcohol Depend. 2015 Jul 1;152:157-63. doi: 10.1016/j.drugalcdep.2015.04.004. Epub 2015 Apr 27.
Results Reference
derived
PubMed Identifier
24577287
Citation
Carroll KM, Kiluk BD, Nich C, Gordon MA, Portnoy GA, Marino DR, Ball SA. Computer-assisted delivery of cognitive-behavioral therapy: efficacy and durability of CBT4CBT among cocaine-dependent individuals maintained on methadone. Am J Psychiatry. 2014 Apr;171(4):436-44. doi: 10.1176/appi.ajp.2013.13070987.
Results Reference
derived
PubMed Identifier
22775772
Citation
Worhunsky PD, Stevens MC, Carroll KM, Rounsaville BJ, Calhoun VD, Pearlson GD, Potenza MN. Functional brain networks associated with cognitive control, cocaine dependence, and treatment outcome. Psychol Addict Behav. 2013 Jun;27(2):477-88. doi: 10.1037/a0029092. Epub 2012 Jul 9.
Results Reference
derived
PubMed Identifier
21190403
Citation
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. doi: 10.3109/10826084.2011.521069.
Results Reference
derived

Learn more about this trial

Computer-Based Training in Cognitive Behavior Therapy

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