Substance UseNCT02043210
CBT for Spanish Speakers
A study testing Standard Treatment as Usual and CBT4CBT plus Standard treatment as usual in people with Substance Use, run by Yale University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Use
- What is being tested?
- Standard Treatment as Usual and CBT4CBT plus Standard treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2014to 11 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Fair Haven Community Health
New Haven, Connecticut, 06511
MAAS
New Haven, Connecticut, 06511
Hispanic Clinic
New Haven, Connecticut, 06519
Substance Abuse Treatment Unit (SATU)
New Haven, Connecticut, 06519
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Use
- Being tested
- Standard Treatment as Usual, CBT4CBT plus Standard treatment as usual
- Keywords
- substance use, Spanish speaking, CBT4CBT
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Treatment as UsualBehavioural
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.
CBT4CBT plus Standard treatment as usualBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment as Usual | Active comparator | Treatment that would normally be received at the clinic typically consisting of individual or group counseling sessions focusing on substance abuse. Receives: Behavioral: Standard Treatment as Usual |
| CBT4CBT plus Standard treatment as usual | Experimental | 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. Receives: Behavioral: CBT4CBT plus Standard treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in substance use
Reduction in substance use will be measured by Time Line Follow back self report and urine toxicology screening
Measured: 8 weeks
Secondary outcomes (1)
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2017
- Study completion11 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Kathleen Carroll, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043210
- Sponsor's protocol ID
- 1110009151
- Other IDs
- 1R01DA030369-01A1
- Status last verified
- Mar 2020
- First submitted
- 10 Jan 2014
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Benitez B, Frankforter T, Nich C, Paris M, Kiluk BD. Comparing content within a culturally-adapted digital treatment for Hispanic patients with alcohol use disorder. NPJ Digit Med. 2025 Dec 8;9(1):23. doi: 10.1038/s41746-025-02197-7.
PubMed 41361015
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Based Training in CBT for Spanish-speaking Substance Users
- ClinicalTrials.gov ID
- NCT02043210
- Acronym / sponsor ID
- 1110009151
- Conditions
- Substance Use
- Keywords
- substance use, Spanish speaking, CBT4CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2014
- Primary completion
- Aug 2017 (actual)
- Study completion
- 11 Sep 2017 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment as Usual | Active comparator | Behavioral: Standard Treatment as UsualTreatment 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 | Experimental | Behavioral: CBT4CBT plus Standard treatment as usualA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Treatment as UsualTreatment normally offered at this clinic which could include individual or group substance use counseling sessions one time per week lasting one hour each time. | Behavioural | Standard Treatment as Usual |
| CBT4CBT plus Standard treatment as usualSubjects 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 | Behavioural | CBT4CBT plus Standard treatment as usual |
Primary outcome
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
1 secondary outcome
Subjects ability to demonstrate coping skills through a computerized role-playing evaluation and homework
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Derived from this study: PubMed 41361015Benitez B, Frankforter T, Nich C, Paris M, Kiluk BD. Comparing content within a culturally-adapted digital treatment for Hispanic patients with alcohol use disorder. NPJ Digit Med. 2025 Dec 8;9(1):23. doi: 10.1038/s41746-025-02197-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Carroll, PhD principal investigator
Yale University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Treatment as Usual and CBT4CBT plus Standard treatment as usual in people with Substance Use, run by Yale University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in substance use (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02043210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.