CBT for Spanish Speakers
Primary Purpose
Substance Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Treatment as Usual
CBT4CBT plus Standard treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use focused on measuring substance use, Spanish speaking, CBT4CBT
Eligibility 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
Sites / Locations
- Fair Haven Community Health
- MAAS
- Hispanic Clinic
- Substance Abuse Treatment Unit (SATU)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Treatment as Usual
CBT4CBT plus Standard treatment as usual
Arm Description
Treatment that would normally be received at the clinic typically consisting of individual or group counseling sessions focusing on substance abuse.
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.
Outcomes
Primary Outcome Measures
Reduction in substance use
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
Computerized role-playing will be used to demonstrate ability to use learned coping skills in various settings.
Full Information
NCT ID
NCT02043210
First Posted
January 10, 2014
Last Updated
March 4, 2020
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02043210
Brief Title
CBT for Spanish Speakers
Official Title
Computer Based Training in CBT for Spanish-speaking Substance Users
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
September 11, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
substance use, Spanish speaking, CBT4CBT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Treatment as Usual
Arm Type
Active Comparator
Arm Description
Treatment that would normally be received at the clinic typically consisting of individual or group counseling sessions focusing on substance abuse.
Arm Title
CBT4CBT plus Standard treatment as usual
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Treatment as Usual
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CBT4CBT plus Standard treatment as usual
Intervention Description
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
Primary Outcome Measure Information:
Title
Reduction in substance use
Description
Reduction in substance use will be measured by Time Line Follow back self report and urine toxicology screening
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework
Description
Computerized role-playing will be used to demonstrate ability to use learned coping skills in various settings.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Carroll, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fair Haven Community Health
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
MAAS
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Hispanic Clinic
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Substance Abuse Treatment Unit (SATU)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CBT for Spanish Speakers
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