Computer Based Training in CBT in Primary Care

Not Applicable

Completed

• Conditions: Substance Abuse
• Interventions: Behavioral: Standard Treatment As Usual (TAU); Behavioral: CBT4CBT program

• Registration Number: NCT03013478
• Lead Sponsor: Yale University

Brief Summary

To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding CBT4CBT to treatment as usual in a community based primary care program in a population of 60 individuals who meet current DSM criteria for substance use disorder other than nicotine.

Detailed Description

The investigators will conduct an initial evaluation of the computer program as an enhancement of treatment as usual in a community-based primary care clinic. Sixty individuals with a current DSM-IV alcohol or substance use disorder will be randomly assigned to either (1) treatment as usual, or (2) treatment as usual plus exposure to the 'CBT for CBT' program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in drug use over 8 weeks. Secondary outcomes include treatment utilization

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Primary Completion: 2018-08-31
• Study Completion: 2018-08-31
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Are 18 years of age or older.
• Are applying for outpatient substance abuse treatment
• Meet current DSM-IV criteria for cocaine, marijuana, opioid, alcohol or other stimulant use disorder
• Are sufficiently stable for 8 weeks of outpatient treatment
• Can commit to 8 weeks of treatment and are willing to be randomized to treatment
• Are willing to provide locator information.

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Exclusion Criteria

• Have an untreated bipolar or schizophrenic disorder
• Have a current legal case pending such that incarceration during the 8 week protocol is likely
• Are in need of detoxification from alcohol, opioids or benzodiazepines

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU plus CBT4CBT program	CBT4CBT program	Treatment normally offered at this clinic PLUS 8 weeks of CBT4CBT computerized therapy.
TAU plus CBT4CBT program	Standard Treatment As Usual (TAU)	Treatment normally offered at this clinic PLUS 8 weeks of CBT4CBT computerized therapy.

Primary Outcome Measures

Name	Time	Method
retention in treatment	0 - 8 weeks	subjects returning for treatment at primary care unit and completing CBT4CBT program for those assigned
reduction in drug use	0 - 8 weeks	Using urine and breathalyzer screening for negative drug and alcohol testing

Trial Locations

Locations (1)

Yale New Haven Hospital St Raphael's Campus; 🇺🇸 New Haven, Connecticut, United States