CBT4CBT With Spanish Alcohol Users

Alcohol Use Disorder Clinical Trial

Official title:

Computer Based Training in CBT for Spanish-Speaking Alcohol Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03474588
• Other study ID #: 2000020677
• Secondary ID: R01AA025605
• Status: Completed
• Phase: N/A
• Start date: August 6, 2019
• Est. completion date: August 16, 2023

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Are 18 years of age or older.

2. Are applying for outpatient alcohol treatment, with some alcohol use in the past 30 days

3. Speak Spanish as their preferred or principal (most commonly spoken) language.

4. Are sufficiently stable for 8 weeks of outpatient treatment

5. Can commit to 8 weeks of treatment and are willing to be randomized to treatment

6. Are willing to provide locator information for follow-up.

Exclusion Criteria:

1. Have an untreated bipolar or schizophrenic disorder

2. Have a current legal case pending such that incarceration during the 8 week protocol is likely

3. Meet DSM-5 criteria for another current substance use disorder (other than nicotine).

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Standard treatment (ST) PLUS web-based CBT4CBT
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)
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

Locations

Country	Name	City	State
United States	Midwestern Connecticut Council on Alcoholism (MCCA)	Bridgeport	Connecticut
United States	Cornell Scott - Hill Health Center	New Haven	Connecticut
United States	Hispanic Clinic of CMHC	New Haven	Connecticut
United States	Midwestern Connecticut Council on Alcoholism (MCCA)	New Haven	Connecticut
United States	Multi-Cultural Ambulatory Addiction Services (MAAS)	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	By week for 8 weeks
Secondary	Secondary outcomes include percent heavy drinking days	Percent heavy drinking days during 8 weeks of trial	8 weeks
Secondary	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	last 4 weeks of treatment