Computer Based Training in Cognitive Behavioral Therapy Web-based

Phase 1

Completed

• Conditions: Substance Abuse
• Interventions: Behavioral: CBT4CBT; Behavioral: Individual clinician-provided CBT; Behavioral: Standard Treatment As Usual (TAU)

• Registration Number: NCT01442597
• Lead Sponsor: Yale University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Study Start: 2012-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBT4CBT	CBT4CBT	A computerized program that teaches skills for stopping drug use and increasing coping skills such as how to understand patterns of drug use, coping with cravings, etc.
Individual clinician-provided CBT	Individual clinician-provided CBT	Individual treatment provided by a trained Cognitive Behavioral Therapy (CBT)clinician who will cover the same skills provided by the CBT4CBT computer program.
Standard Treatment as Usual (TAU)	Standard Treatment As Usual (TAU)	Treatment that would normally be received at the clinic typically consisting of individual or group counseling sessions focusing on substance abuse.

Primary Outcome Measures

Name	Time	Method
Reduction in drug abuse	12 weeks

Secondary Outcome Measures

Name	Time	Method
Subjects ability to demonstrate coping skills through a computerized role-playing evaluation	12 weeks

Trial Locations

Locations (1)

Substance Abuse Treatment Unit (SATU); 🇺🇸 New Haven, Connecticut, United States