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OpenTrials
Completed

NCT Number: NCT03474588

CBT4CBT With Spanish 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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Midwestern Connecticut Council on Alcoholism (MCCA), Bridgeport, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Standard treatment (ST) PLUS web-based CBT4CBT

Behavioral

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)

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Secondary Outcomes Include Percent Heavy Drinking Days

    Time frame: 8 weeks

    Percent heavy drinking days during 8 weeks of trial

  2. Number of Individuals With no Heavy Drinking Days in the Last 4 Weeks of Treatment

    Time frame: last 4 weeks of treatment (4 weeks)

    Number of individuals with no heavy drinking days in the last 4 weeks of treatment

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Computer Based Training in CBT for Spanish-Speaking Alcohol Users

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2018
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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