N/A
Completed N=51
CBT4CBT With Spanish Alcohol Users
Source: ClinicalTrials.gov NCT03474588 ↗Enrolled (actual)
51
Serious AEs
11.8%
Results posted
Nov 2024
Primary outcomePrimary: The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week — 73.29; 66.96; 88.20; 79.59 percentage of days abstinent per week — p=0.30
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week |
73.29; 66.96; 88.20; 79.59; 83.23; 78.06 | 0.30 |
| PRIMARY Monthly Abstinence From Alcohol |
89.03; 77.46; 89.85; 76.88; 90.67; 76.31 | 0.14 |
| SECONDARY Secondary Outcomes Include Percent Heavy Drinking Days |
6.4; 15.2 | 0.097 |
| SECONDARY Number of Individuals With no Heavy Drinking Days in the Last 4 Weeks of Treatment |
11; 13 | 0.802 |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT03474588). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.