CBT for Spanish Speakers

Not Applicable

Completed

• Conditions: Substance Use
• Interventions: Behavioral: Standard Treatment as Usual; Behavioral: CBT4CBT plus Standard treatment as usual

• Registration Number: NCT02043210
• Lead Sponsor: Yale University

Brief Summary

The investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) in Spanish. This program specifically designed for Spanish-speaking substance users to evaluate its effectiveness relative to standard outpatient counseling at the Hispanic Clinic. 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 use treatment.

Detailed Description

100 Spanish-speaking substance using individuals seeking treatment at the Hispanic Clinic of the Connecticut Mental Health Center will be randomized to (1) standard outpatient counseling at the Hispanic Clinic (typically consisting of weekly group counseling), OR (2) CBT4CBT plus standard outpatient counseling. Treatments will be delivered over an 8-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 substance use by time, confirmed by urine toxicology screens and breathalyzers). 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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-10
• Study First Submitted QC: 2014-01-19
• Study First Posted: 2014-01-23
• Primary Completion: 2017-08
• Study Completion: 2017-09-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-04
• Last Update Posted: 2020-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• Are 18 years of age or older.
• Are applying for outpatient, non-agonist substance abuse treatment at the Hispanic Clinic.
• Meet current DSM-IV criteria for cocaine, marijuana, opioid, alcohol or other stimulant abuse or dependence.
• 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 for follow-up.
• Speak Spanish as their preferred or principal (most commonly spoken)language

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Exclusion Criteria

• Have an untreated bipolar or schizophrenic disorder.
• Who have a current legal case pending such that incarceration during 8-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
Standard Treatment as Usual	Standard Treatment as Usual	Treatment that would normally be received at the clinic typically consisting of individual or group counseling sessions focusing on substance abuse.
CBT4CBT plus Standard treatment as usual	CBT4CBT plus Standard treatment as usual	A computerized program that teaches skills for stopping substance use by increasing coping skills such as how to understand patterns of drug use, coping with cravings, etc. plus standard treatment as usual.

Primary Outcome Measures

Name	Time	Method
Reduction in substance use	8 weeks	Reduction in substance use will be measured by Time Line Follow back self report and urine toxicology screening

Secondary Outcome Measures

Name	Time	Method
Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework	8 weeks	Computerized role-playing will be used to demonstrate ability to use learned coping skills in various settings.

Trial Locations

Locations (4)

Hispanic Clinic; 🇺🇸 New Haven, Connecticut, United States

Fair Haven Community Health; 🇺🇸 New Haven, Connecticut, United States

MAAS; 🇺🇸 New Haven, Connecticut, United States

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