CBT4CBT With Spanish Alcohol Users

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    90
  • sponsor
    Yale University
Updated on 14 March 2022

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.

Details
Condition Alcohol Use Disorder
Treatment Standard treatment (ST) PLUS web-based CBT4CBT, Standard Treatment (ST)
Clinical Study IdentifierNCT03474588
SponsorYale University
Last Modified on14 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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