Clinical trial NCT03474588: CBT4CBT With Spanish Alcohol Users
Official title: Computer Based Training in CBT for Spanish-Speaking Alcohol Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-03-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week
timeFrame: By week for 8 weeks
measure: Monthly Abstinence From Alcohol
timeFrame: Months 3 through 8 (6 months total)
Secondary outcomes:
measure: Secondary Outcomes Include Percent Heavy Drinking Days
timeFrame: 8 weeks
measure: Number of Individuals With no Heavy Drinking Days in the Last 4 Weeks of Treatment
timeFrame: last 4 weeks of treatment (4 weeks)
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: Midwestern Connecticut Council on Alcoholism (MCCA)
state: Connecticut
city: New Haven
country: United States
facility: Cornell Scott - Hill Health Center
state: Connecticut
city: New Haven
country: United States
facility: Hispanic Clinic of CMHC
state: Connecticut
city: New Haven
country: United States
facility: Midwestern Connecticut Council on Alcoholism (MCCA)
state: Connecticut
city: New Haven
country: United States
facility: Multi-Cultural Ambulatory Addiction Services (MAAS)
state: Connecticut
Study officials:
affiliation: Yale University
name: Manuel Paris, PsyD
role: PRINCIPAL_INVESTIGATOR
References: