Clinical trial NCT00350610: Computer-Based Training in Cognitive Behavior Therapy
Official title: Computer-Based Training in Cognitive Behavior Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine Abuse
Keywords: cognitive behavior therapy
computer assisted instruction
drug abuse therapy
educational resource design and development
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2006-07-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: reduction in drug use
timeFrame: 8 weeks
Secondary outcomes:
measure: patients ability to demonstrate coping skills through a computerized role-playing evaluation
timeFrame: 8 weeks
measure: retention in treatment
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: APT Foundation Orchard Hill Clinic
state: Connecticut
Study officials:
affiliation: Yale University/Department of Psychiatry
name: Kathleen Carroll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.