Alcohol Use Disorder
Conditions
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.
Interventions
BEHAVIORALStandard 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
BEHAVIORALStandard 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
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | 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. |
| Monthly Abstinence From Alcohol | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcomes Include Percent Heavy Drinking Days | 8 weeks | Percent heavy drinking days during 8 weeks of trial |
| Number of Individuals With no Heavy Drinking Days in the Last 4 Weeks of Treatment | last 4 weeks of treatment (4 weeks) | Number of individuals with no heavy drinking days in the last 4 weeks of treatment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment (ST) This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant
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 | 28 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT This is the same as the treatment normally received at this clinic. This will be tailored to participants' needs, but generally includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks and include issues such as:
* Teaching about the treatment program
* Teaching important ideas about recovery
* Increasing knowledge about specific problems about addiction
* Demonstrating new ways of coping with skills designed to fit each participant PLUS
Participants will have access 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) 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 | 23 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Standard Treatment (ST) | Standard Treatment (ST) PLUS Web-based CBT4CBT | Total |
|---|---|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 13 | 44.8 years STANDARD_DEVIATION 11.9 | 41.9 years STANDARD_DEVIATION 12.7 |
| Age first used alcohol | 17.1 years STANDARD_DEVIATION 4.9 | 17.5 years STANDARD_DEVIATION 6.8 | 17.3 years STANDARD_DEVIATION 5.8 |
| Alcohol Use Disorder (AUD) Severity Rating Mild | 0 Participants | 1 Participants | 1 Participants |
| Alcohol Use Disorder (AUD) Severity Rating Moderate | 7 Participants | 6 Participants | 13 Participants |
| Alcohol Use Disorder (AUD) Severity Rating Severe | 21 Participants | 16 Participants | 37 Participants |
| Alcohol Use Disorders Identification Test (Audit) Score 16 or higher | 18 Participants | 14 Participants | 32 Participants |
| Client Origin of birth Client Carribean Island | 0 Participants | 1 Participants | 1 Participants |
| Client Origin of birth Client Mexico | 14 Participants | 6 Participants | 20 Participants |
| Client Origin of birth Client Other Central American country | 5 Participants | 6 Participants | 11 Participants |
| Client Origin of birth Client Puerto Rico | 7 Participants | 7 Participants | 14 Participants |
| Client Origin of birth Client South American country | 1 Participants | 2 Participants | 3 Participants |
| Client Origin of birth Client United States | 1 Participants | 1 Participants | 2 Participants |
| Client Origin of birth Father Carribean Island | 0 Participants | 1 Participants | 1 Participants |
| Client Origin of birth Father Mexico | 14 Participants | 6 Participants | 20 Participants |
| Client Origin of birth Father Other Central American country | 6 Participants | 7 Participants | 13 Participants |
| Client Origin of birth Father Puerto Rico | 7 Participants | 7 Participants | 14 Participants |
| Client Origin of birth Father South American country | 1 Participants | 2 Participants | 3 Participants |
| Client Origin of birth Father United States | 0 Participants | 0 Participants | 0 Participants |
| Client Origin of birth Mother Carribean Island | 0 Participants | 1 Participants | 1 Participants |
| Client Origin of birth Mother Mexico | 14 Participants | 6 Participants | 20 Participants |
| Client Origin of birth Mother Other Central American country | 6 Participants | 7 Participants | 13 Participants |
| Client Origin of birth Mother Puerto Rico | 7 Participants | 7 Participants | 14 Participants |
| Client Origin of birth Mother South American country | 1 Participants | 2 Participants | 3 Participants |
| Client Origin of birth Mother United States | 0 Participants | 0 Participants | 0 Participants |
| Completed High School | 12 Participants | 12 Participants | 24 Participants |
| Current anxiety disorder | 4 Participants | 3 Participants | 7 Participants |
| Current major depression | 10 Participants | 11 Participants | 21 Participants |
| Current PTSD by SCID | 3 Participants | 6 Participants | 9 Participants |
| Days of alcohol use in the past 28 | 9.1 days STANDARD_DEVIATION 9.3 | 7.7 days STANDARD_DEVIATION 7.3 | 8.5 days STANDARD_DEVIATION 8.4 |
| Days of heavy alcohol use in the past 28 | 7 days STANDARD_DEVIATION 8.7 | 5.4 days STANDARD_DEVIATION 6.4 | 6.3 days STANDARD_DEVIATION 7.7 |
| Days paid for work in past 28 | 14.1 days STANDARD_DEVIATION 11.6 | 10.7 days STANDARD_DEVIATION 10.1 | 12.6 days STANDARD_DEVIATION 11 |
| Diagnosed PTSD by PCL-5 | 5 Participants | 5 Participants | 10 Participants |
| Drinks per drinking days in the past 28 | 8.6 drinks STANDARD_DEVIATION 5.9 | 10.9 drinks STANDARD_DEVIATION 14.1 | 9.6 drinks STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 23 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Lifetime anxiety disorder | 5 Participants | 6 Participants | 11 Participants |
| Lifetime major depression | 16 Participants | 11 Participants | 27 Participants |
| Lifetime PTSD by SCID | 3 Participants | 7 Participants | 10 Participants |
| Never married/living alone | 15 Participants | 19 Participants | 34 Participants |
| On parole or probation | 7 Participants | 8 Participants | 15 Participants |
| On Public Assistance | 10 Participants | 6 Participants | 16 Participants |
| Percent days of alcohol abstinence at week 0 | 73.5 percentage of days STANDARD_DEVIATION 35.4 | 77 percentage of days STANDARD_DEVIATION 25.8 | 75.1 percentage of days STANDARD_DEVIATION 31.1 |
| Percent days of alcohol abstinence in the past 28 | 67.5 percentage of days STANDARD_DEVIATION 33.2 | 72.4 percentage of days STANDARD_DEVIATION 26.2 | 69.7 percentage of days STANDARD_DEVIATION 30 |
| Percent days of heavy drinking at week 0 | 20.4 percentage of days STANDARD_DEVIATION 32.2 | 14.9 percentage of days STANDARD_DEVIATION 20.9 | 17.9 percentage of days STANDARD_DEVIATION 27.5 |
| Percent days of heavy drinking in the past 28 | 25.2 percentage of days STANDARD_DEVIATION 31.1 | 19.3 percentage of days STANDARD_DEVIATION 23 | 22.5 percentage of days STANDARD_DEVIATION 27.6 |
| Pre-treatment Alcohol Symptom Count | 7.7 symptom count STANDARD_DEVIATION 2.4 | 7.6 symptom count STANDARD_DEVIATION 2.6 | 7.7 symptom count STANDARD_DEVIATION 2.5 |
| Pre-treatment AUDIT Score | 20.3 score on a scale STANDARD_DEVIATION 9.2 | 18.9 score on a scale STANDARD_DEVIATION 7.7 | 19.7 score on a scale STANDARD_DEVIATION 8.5 |
| Previous computer experience | 21 Participants | 12 Participants | 33 Participants |
| Referred by criminal justice system | 7 Participants | 10 Participants | 17 Participants |
| Region of Enrollment United States | 28 participants | 23 participants | 51 participants |
| Sex: Female, Male Female | 11 Participants | 5 Participants | 16 Participants |
| Sex: Female, Male Male | 17 Participants | 18 Participants | 35 Participants |
| Unemployed | 10 Participants | 9 Participants | 19 Participants |
| Years living in United States | 19.5 years STANDARD_DEVIATION 14 | 19.2 years STANDARD_DEVIATION 10 | 19.3 years STANDARD_DEVIATION 12.2 |
| Years of alcohol use | 21.1 years STANDARD_DEVIATION 13.2 | 25.8 years STANDARD_DEVIATION 14.9 | 23.2 years STANDARD_DEVIATION 14 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 1 / 23 |
| other Total, other adverse events | 0 / 28 | 0 / 23 |
| serious Total, serious adverse events | 2 / 28 | 4 / 23 |
Outcome results
Primary
Monthly Abstinence From Alcohol
Estimated means of sustained abstinence calculated as percent days per month from month 3 through 8 in post intervention follow up.
Time frame: Months 3 through 8 (6 months total)
Population: All participants assessed during the period.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Treatment (ST) PLUS Web-based CBT4CBT | Monthly Abstinence From Alcohol | month 4 | 89.85 percentage of days abstinent in a month | Standard Deviation 10.55 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT | Monthly Abstinence From Alcohol | month 6 | 91.49 percentage of days abstinent in a month | Standard Deviation 10.55 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT | Monthly Abstinence From Alcohol | month 3 | 89.03 percentage of days abstinent in a month | Standard Deviation 10.55 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT | Monthly Abstinence From Alcohol | month 7 | 92.30 percentage of days abstinent in a month | Standard Deviation 10.55 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT | Monthly Abstinence From Alcohol | month 5 | 90.67 percentage of days abstinent in a month | Standard Deviation 10.55 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT | Monthly Abstinence From Alcohol | month 8 | 93.12 percentage of days abstinent in a month | Standard Deviation 10.55 |
| Standard Treatment (ST) | Monthly Abstinence From Alcohol | month 5 | 76.31 percentage of days abstinent in a month | Standard Deviation 29.3 |
| Standard Treatment (ST) | Monthly Abstinence From Alcohol | month 3 | 77.46 percentage of days abstinent in a month | Standard Deviation 29.3 |
| Standard Treatment (ST) | Monthly Abstinence From Alcohol | month 4 | 76.88 percentage of days abstinent in a month | Standard Deviation 29.3 |
| Standard Treatment (ST) | Monthly Abstinence From Alcohol | month 8 | 74.59 percentage of days abstinent in a month | Standard Deviation 29.3 |
| Standard Treatment (ST) | Monthly Abstinence From Alcohol | month 6 | 75.74 percentage of days abstinent in a month | Standard Deviation 29.3 |
| Standard Treatment (ST) | Monthly Abstinence From Alcohol | month 7 | 75.17 percentage of days abstinent in a month | Standard Deviation 29.3 |
Comparison: Random Effects Regression Model (RERM), included in the model were treatment, time and the interaction of time and treatment.p-value: 0.1495% CI: [-0.46, 3.24]Regression, Linear
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, presented are the raw means at each time point.
Time frame: By week for 8 weeks
Population: One participant was lost to follow up beginning week 4 in the Standard treatment (ST) PLUS web-based CBT4CBT.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Treatment (ST) PLUS Web-based CBT4CBT | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 0 (baseline) | 73.29 percentage of days abstinent per week | Standard Deviation 25.71 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 2 | 83.23 percentage of days abstinent per week | Standard Deviation 22.65 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 1 | 88.20 percentage of days abstinent per week | Standard Deviation 19.57 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 3 | 91.30 percentage of days abstinent per week | Standard Deviation 11.98 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 4 | 90.26 percentage of days abstinent per week | Standard Deviation 15.52 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 5 | 92.86 percentage of days abstinent per week | Standard Deviation 12.27 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 6 | 89.61 percentage of days abstinent per week | Standard Deviation 14.74 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 7 | 87.01 percentage of days abstinent per week | Standard Deviation 24.11 |
| Standard Treatment (ST) PLUS Web-based CBT4CBT | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 8 | 84.42 percentage of days abstinent per week | Standard Deviation 22.44 |
| Standard Treatment (ST) | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 6 | 80.10 percentage of days abstinent per week | Standard Deviation 29.7 |
| Standard Treatment (ST) | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 4 | 71.43 percentage of days abstinent per week | Standard Deviation 30.61 |
| Standard Treatment (ST) | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 2 | 78.06 percentage of days abstinent per week | Standard Deviation 29.22 |
| Standard Treatment (ST) | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 5 | 72.45 percentage of days abstinent per week | Standard Deviation 28.29 |
| Standard Treatment (ST) | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 0 (baseline) | 66.96 percentage of days abstinent per week | Standard Deviation 34.59 |
| Standard Treatment (ST) | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 8 | 75.51 percentage of days abstinent per week | Standard Deviation 31.55 |
| Standard Treatment (ST) | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 1 | 79.59 percentage of days abstinent per week | Standard Deviation 30.97 |
| Standard Treatment (ST) | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 7 | 77.04 percentage of days abstinent per week | Standard Deviation 31.67 |
| Standard Treatment (ST) | The Primary Outcome Measure Will be Percent Days of Abstinence (PDA) by Week | week 3 | 77.55 percentage of days abstinent per week | Standard Deviation 31.69 |
p-value: 0.3Regression, Linear
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
Time frame: last 4 weeks of treatment (4 weeks)
Population: Participants completing the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Treatment (ST) PLUS Web-based CBT4CBT | Number of Individuals With no Heavy Drinking Days in the Last 4 Weeks of Treatment | 11 Participants |
| Standard Treatment (ST) | Number of Individuals With no Heavy Drinking Days in the Last 4 Weeks of Treatment | 13 Participants |
p-value: 0.802Chi-squared
Secondary
Secondary Outcomes Include Percent Heavy Drinking Days
Percent heavy drinking days during 8 weeks of trial
Time frame: 8 weeks
Population: Participants completing the full study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment (ST) PLUS Web-based CBT4CBT | Secondary Outcomes Include Percent Heavy Drinking Days | 6.4 percentage of heavy drinking days | Standard Deviation 10.3 |
| Standard Treatment (ST) | Secondary Outcomes Include Percent Heavy Drinking Days | 15.2 percentage of heavy drinking days | Standard Deviation 22.7 |
p-value: 0.097ANOVA