Computer-Based Training in Cognitive Behavior Therapy

NCT ID: NCT00350610

Last Updated: 2013-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Cocaine Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type OTHER

Standard treatment as usual in a community based treatment setting

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.

Group Type EXPERIMENTAL

Treatment as usual (TAU)

Intervention Type OTHER

Standard treatment as usual in a community based treatment setting

CBT for CBT

Intervention Type BEHAVIORAL

Standard treatment as usual (TAU) plus computer based therapy using CBT

Interventions

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Treatment as usual (TAU)

Standard treatment as usual in a community based treatment setting

Intervention Type OTHER

CBT for CBT

Standard treatment as usual (TAU) plus computer based therapy using CBT

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen Carroll, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University/Department of Psychiatry

Locations

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APT Foundation Orchard Hill Clinic

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30240978 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27658192 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25982006 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24577287 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22775772 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21190403 (View on PubMed)

Other Identifiers

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DA015969

Identifier Type: -

Identifier Source: secondary_id

0207017894

Identifier Type: -

Identifier Source: org_study_id

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