Clinical trial NCT01442597: Computer Based Training in Cognitive Behavioral Therapy Web-based
Official title: Computer Based Training in Cognitive Behavioral Therapy Web-based
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Substance 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: 2011-09-28
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT program to evaluate its effectiveness relative to standard outpatient counseling at SATU. The computer-based training program (CBT4CBT) 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: One hundred eighty drug-using individuals seeking treatment at the Substance Abuse Treatment Unit (SATU) of the Connecticut Mental Health Center will be randomized to (1) standard outpatient counseling at SATU (typically consisting of weekly group counseling), (2) individual clinician delivered CBT, or (3) web-based CBT4CBT. Treatments will be delivered over a 12-week period with a six-month follow-up after termination of the study treatments. The primary outcome measures will be reduction in substance use (frequency of drug use by time, confirmed by urine toxicology screens). Secondary outcomes will include treatment utilization and cost, several measures intended to detect whether web-based CBT4CBT retains key characteristics of traditional clinician-administered CBT (e.g., acquisition of coping skills, use of change strategies), participant characteristics which will be evaluated as potential moderators of outcome, as well as participant satisfaction and treatment credibility.

Eligibility criteria: Inclusion Criteria:

* Are 18 years of age or older.
* Are applying for outpatient, non-agonist substance abuse treatment at SATU.
* Meet current DSM-IV criteria for cocaine, marijuana,opioid,or amphetamine dependence.
* Are sufficiently stable for 12 weeks of outpatient treatment.
* Can commit to 12 weeks of treatment and are willing to be randomized to treatment
* Are willing to provide locator information for follow-up.
* Are fluent in English and have a 6th grader or higher reading level

Exclusion Criteria:

* Have an untreated bipolar or schizophrenic disorder.
* Who have a current legal case pending such that incarceration during 12-week protocol is likely.
* Are physically dependent on alcohol, opioids or benzodiazepines

Primary outcomes:
measure: Reduction in drug abuse
timeFrame: 12 weeks
Secondary outcomes:
measure: Subjects ability to demonstrate coping skills through a computerized role-playing evaluation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Substance Abuse Treatment Unit (SATU)
state: Connecticut
Study officials:
affiliation: Yale University
name: Kathleen Carroll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kiluk BD, Nich C, Buck MB, Devore KA, Frankforter TL, LaPaglia DM, Muvvala SB, Carroll KM. Randomized Clinical Trial of Computerized and Clinician-Delivered CBT in Comparison With Standard Outpatient Treatment for Substance Use Disorders: Primary Within-Treatment and Follow-Up Outcomes. Am J Psychiatry. 2018 Sep 1;175(9):853-863. doi: 10.1176/appi.ajp.2018.17090978. Epub 2018 May 24.