Alcohol Use DisorderNCT03474588
CBT4CBT With Spanish Alcohol Users
A study testing Standard treatment (ST) PLUS web-based CBT4CBT and Standard Treatment (ST) in people with Alcohol Use Disorder, run by Yale University at 5 sites in United States.
Trial summary
Specific aims are as follows: To adapt our existing CBT4CBT program for use with Spanish-speaking alcohol users in a web-based platform To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding CBT4CBT-Spanish to treatment as usual in a community based treatment program in a population of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Standard treatment (ST) PLUS web-based CBT4CBT and Standard Treatment (ST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 5 sitesUnited States
- Study dates
- 6 Aug 2019to 16 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- 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 alcohol treatment, with some alcohol use in the past 30 days
- Speak Spanish as their preferred or principal (most commonly spoken) language.
- 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.
Who cannot join
- Have an untreated bipolar or schizophrenic disorder
- Have a current legal case pending such that incarceration during the 8 week protocol is likely
- Meet DSM-5 criteria for another current substance use disorder (other than nicotine).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Midwestern Connecticut Council on Alcoholism (MCCA)
Bridgeport, Connecticut, 06511
Cornell Scott - Hill Health Center
New Haven, Connecticut, 06511
Hispanic Clinic of CMHC
New Haven, Connecticut, 06511
Midwestern Connecticut Council on Alcoholism (MCCA)
New Haven, Connecticut, 06511
Multi-Cultural Ambulatory Addiction Services (MAAS)
New Haven, Connecticut, 06511
About this study
Official title: Computer Based Training in CBT for Spanish-Speaking Alcohol Users
Specific aims are as follows:
- To adapt our existing CBT4CBT program for use with Spanish-speaking alcohol users in a web-based platform
- To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding CBT4CBT-Spanish to treatment as usual in a community based treatment program in a population of 90 Spanish-speaking individuals who meet current criteria for alcohol use disorder
- To evaluate the long-term durability and/or delayed emergence of treatment effects through a six month follow-up after termination of the study treatments. Given previous evidence regarding the durability of standard clinician-delivered CBT and computer-assisted CBT4CBT, we hypothesize that CBT4CBTSpanish will be significantly more effective than standard treatment alone through the follow-up.
Read the detailed description
The investigators will conduct a Stage 1 randomized clinical trial evaluating the program in which 90 Spanish-speaking individuals with alcohol use disorder will be randomized to (1) standard outpatient counseling at the Hispanic Clinic (ST; typically consisting of weekly individual and group supportive counseling) or (2) CBT4CBT-Spanish as an adjunct to ST. Other aspects of the trial will parallel those in the investogators completed trial of the English version of CBT4CBT-Alcohol to facilitate comparability across studies. Treatments will be delivered over an 8-week period with a 6-month follow-up to assess durability and/or delayed emergence of treatment effects. The primary outcome measure will be percent days of abstinence (PDA) by week. Secondary outcomes include percent heavy drinking days and number of individuals with no heavy drinking days in the last 4 weeks of treatment.
Participants will be 90 individuals seeking treatment for alcohol use at the Hispanic Clinic of CMHC. The clinic treats a heterogeneous population, where 42% of those in the co-occurring treatment program report alcohol as their principal substance related issue and 43% are women. As reported above, the investigators have demonstrated the ability to recruit, randomize, retain, and follow-up high numbers of closely related samples in this setting.
- Conditions
- Alcohol Use Disorder
- Being tested
- Standard treatment (ST) PLUS web-based CBT4CBT, Standard Treatment (ST)
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatment (ST) PLUS web-based CBT4CBTBehavioural
Participants will have access to the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on
Standard Treatment (ST)Behavioural
ST includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard Treatment (ST) | Active comparator | This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant Receives: Behavioral: Standard Treatment (ST) |
| 2. Standard treatment (ST) PLUS web-based CBT4CBT | Experimental | This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant PLUS
Participants will have access the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on. Receives: Behavioral: Standard treatment (ST) PLUS web-based CBT4CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week
The primary outcome measure will be percent days of abstinence (PDA) by week, presented are the raw means at each time point.
Measured: By week for 8 weeks
Monthly Abstinence From Alcohol
Estimated means of sustained abstinence calculated as percent days per month from month 3 through 8 in post intervention follow up.
Measured: Months 3 through 8 (6 months total)
Secondary outcomes (2)
Secondary Outcomes Include Percent Heavy Drinking Days
Percent heavy drinking days during 8 weeks of trial
Measured: 8 weeks
Number of Individuals With no Heavy Drinking Days in the Last 4 Weeks of Treatment
Number of individuals with no heavy drinking days in the last 4 weeks of treatment
Measured: last 4 weeks of treatment (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start6 Aug 2019
- Primary completion16 Aug 2023
- Study completion16 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies 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
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Manuel Paris, PsyD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474588
- Sponsor's protocol ID
- 2000020677
- Other IDs
- R01AA025605
- Status last verified
- Nov 2024
- First submitted
- 15 Mar 2018
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Based Training in CBT for Spanish-Speaking Alcohol Users
- ClinicalTrials.gov ID
- NCT03474588
- Acronym / sponsor ID
- 2000020677
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 16 Aug 2023 (actual)
- Study completion
- 16 Aug 2023 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific aims are as follows:
- To adapt our existing CBT4CBT program for use with Spanish-speaking alcohol users in a web-based platform
- To conduct an 8-week randomized trial evaluating the feasibility and efficacy of adding CBT4CBT-Spanish to treatment as usual in a community based treatment program in a population of 90 Spanish-speaking individuals who meet current criteria for alcohol use disorder
- To evaluate the long-term durability and/or delayed emergence of treatment effects through a six month follow-up after termination of the study treatments. Given previous evidence regarding the durability of standard clinician-delivered CBT and computer-assisted CBT4CBT, we hypothesize that CBT4CBTSpanish will be significantly more effective than standard treatment alone through the follow-up.
Detailed description
The investigators will conduct a Stage 1 randomized clinical trial evaluating the program in which 90 Spanish-speaking individuals with alcohol use disorder will be randomized to (1) standard outpatient counseling at the Hispanic Clinic (ST; typically consisting of weekly individual and group supportive counseling) or (2) CBT4CBT-Spanish as an adjunct to ST. Other aspects of the trial will parallel those in the investogators completed trial of the English version of CBT4CBT-Alcohol to facilitate comparability across studies. Treatments will be delivered over an 8-week period with a 6-month follow-up to assess durability and/or delayed emergence of treatment effects. The primary outcome measure will be percent days of abstinence (PDA) by week. Secondary outcomes include percent heavy drinking days and number of individuals with no heavy drinking days in the last 4 weeks of treatment.
Participants will be 90 individuals seeking treatment for alcohol use at the Hispanic Clinic of CMHC. The clinic treats a heterogeneous population, where 42% of those in the co-occurring treatment program report alcohol as their principal substance related issue and 43% are women. As reported above, the investigators have demonstrated the ability to recruit, randomize, retain, and follow-up high numbers of closely related samples in this setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment (ST) | Active comparator | Behavioral: Standard Treatment (ST)This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as: * Teaching about the treatment program * Teaching important ideas about recovery * Increasing knowledge about specific problems about addiction * Demonstrating new ways of coping with skills designed to fit each participant |
| 2. Standard treatment (ST) PLUS web-based CBT4CBT | Experimental | Behavioral: Standard treatment (ST) PLUS web-based CBT4CBTThis is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as: * Teaching about the treatment program * Teaching important ideas about recovery * Increasing knowledge about specific problems about addiction * Demonstrating new ways of coping with skills designed to fit each participant PLUS Participants will have access the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are 18 years of age or older.
- Are applying for outpatient alcohol treatment, with some alcohol use in the past 30 days
- Speak Spanish as their preferred or principal (most commonly spoken) language.
- 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
- Have a current legal case pending such that incarceration during the 8 week protocol is likely
- Meet DSM-5 criteria for another current substance use disorder (other than nicotine).
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 (ST) PLUS web-based CBT4CBTParticipants will have access to the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on | Behavioural | 2. Standard treatment (ST) PLUS web-based CBT4CBT |
| Standard Treatment (ST)ST includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks | Behavioural | Standard Treatment (ST) |
Primary outcome
The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week
Time frame: By week for 8 weeks
The primary outcome measure will be percent days of abstinence (PDA) by week, presented are the raw means at each time point.
Monthly Abstinence From Alcohol
Time frame: Months 3 through 8 (6 months total)
Estimated means of sustained abstinence calculated as percent days per month from month 3 through 8 in post intervention follow up.
2 secondary outcomes
Secondary Outcomes Include Percent Heavy Drinking Days
Time frame: 8 weeks
Number of Individuals With no Heavy Drinking Days in the Last 4 Weeks of Treatment
Time frame: last 4 weeks of treatment (4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Individual participant dataSharing planned: No
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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.
Manuel Paris, PsyD principal investigator
Yale University
5 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 (ST) PLUS web-based CBT4CBT and Standard Treatment (ST) in people with Alcohol Use Disorder, run by Yale University at 5 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 6 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week (time frame: By week for 8 weeks). The study lists 2 primary outcomes in all. 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 NCT03474588, 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 26 Nov 2024.