CBT for Spanish Speakers

Computer Based Training in CBT for Spanish-speaking Substance Users

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.

Study Overview

• Status: Completed
• Conditions: Substance Use
• Intervention / Treatment: Behavioral: Standard Treatment as Usual; Behavioral: CBT4CBT plus Standard treatment as usual

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 Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Substance Abuse Treatment Unit (SATU)
    • New Haven, Connecticut, United States, 06511
      • Fair Haven Community Health
    • New Haven, Connecticut, United States, 06511
      • MAAS
    • New Haven, Connecticut, United States, 06519
      • Hispanic Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Standard Treatment as Usual; Treatment normally offered at this clinic which could include individual or group substance use counseling sessions one time per week lasting one hour each time.
Experimental: 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.	Behavioral: CBT4CBT plus Standard treatment as usual; Subjects work with a computerized program in Spanish that teaches skills for stopping substance use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus Standard treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in substance use	Reduction in substance use will be measured by Time Line Follow back self report and urine toxicology screening	8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Kathleen Carroll, PhD, Yale University

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): September 11, 2017

Study Registration Dates

• First Submitted: January 10, 2014
• First Submitted That Met QC Criteria: January 19, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: substance use, Spanish speaking, CBT4CBT
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 1110009151; 1R01DA030369-01A1 (U.S. NIH Grant/Contract)