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CBT for Spanish Speakers

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Yale University
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02043210
First received: January 10, 2014
Last updated: June 20, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Substance Use Behavioral: Standard Treatment as Usual Behavioral: CBT4CBT plus Standard treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Computer Based Training in CBT for Spanish-speaking Substance Users

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Reduction in substance use [ Time Frame: 8 weeks ]
    Reduction in substance use will be measured by Time Line Follow back self report and urine toxicology screening


Secondary Outcome Measures:
  • Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework [ Time Frame: 8 weeks ]
    Computerized role-playing will be used to demonstrate ability to use learned coping skills in various settings.


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02043210

Contacts
Contact: Yudilyn Jaramillo, MPH yudilyn.jaramillo@yale.edu
Contact: Michelle Silva, PsyD 203-974-5805 michelle.silva@yale.edu

Locations
United States, Connecticut
Fair Haven Community Health Recruiting
New Haven, Connecticut, United States, 06511
Contact: Yudilyn Jaramillo, MPH       yudilyn.jaramillo@yale.edu   
Contact: Michelle Silva, PHD       michelle.silva@yale.edu   
MAAS Active, not recruiting
New Haven, Connecticut, United States, 06511
Hispanic Clinic Active, not recruiting
New Haven, Connecticut, United States, 06519
Substance Abuse Treatment Unit (SATU) Active, not recruiting
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Kathleen Carroll, PhD Yale University
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02043210     History of Changes
Other Study ID Numbers: 1110009151
Study First Received: January 10, 2014
Last Updated: June 20, 2017

Keywords provided by Yale University:
substance use, Spanish speaking, CBT4CBT

ClinicalTrials.gov processed this record on June 22, 2017