Alcohol Use Disorder
Conditions
Brief summary
Evaluate the efficacy of CBT4CBT and clinician-delivered CBT relative to standard treatment for reducing alcohol use
Detailed description
Evaluate the efficacy of Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) and clinician-delivered Cognitive Behavioral Therapy (CBT) relative to standard treatment for reducing alcohol use through an 8-week randomized trial with 6-month follow-up. Our primary hypothesis is that either form of CBT will be more effective than standard treatment at increasing the percentage of days abstinent during treatment (8 weeks) and through the follow-up (6 months), assessed via Timeline FollowBack interviews.
Interventions
BEHAVIORALIndividual clinician-provided CBT
Individual clinician-provided CBT
BEHAVIORALCBT4CBT
CBT computer program assisted therapy
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
Individuals will be included who: * Are 18 years of age or older. * Are applying for outpatient alcohol treatment and meet current DSM-5 criteria for alcohol use disorder, consuming at least 14/7 drinks (men/women) per week with at least 4 heavy drinking days reported in the past 28 days, * Are sufficiently stable for 8 weeks of outpatient treatment and can commit to a 6-month follow-up * Are willing to provide locator information for follow-up, and * Are fluent in English and have a 6th grade or higher reading level.
Exclusion criteria
Individuals will be excluded who: * Have an untreated bipolar or schizophrenic disorder, * Have a current legal case pending such that incarceration during the 8-week protocol is likely, * Have been prescribed an alcohol pharmacotherapy (e.g., disulfiram, naltrexone) within the past two weeks, or * Are physically dependent on alcohol, opioids or benzodiazepines such that immediate medical detoxification is necessary for safety purposes (individuals demonstrating significant withdrawal symptoms would be eligible for re-screening following brief medical detoxification, which is arranged by RCS staff at triage).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back | Baseline up to 8 weeks | The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure alcohol use over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use. |
| Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | from end of treatment at week 8 up to 6 months | The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure change over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use summarized monthly. |
Countries
United States
Participant flow
Pre-assignment details
Initiated is the number that attended at least 1 treatment session. Every attempt was made to get post treatment and follow up interviews on everyone randomized, regardless of how much of the active treatment the participant received.
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment as Usual (TAU) This is the regular treatment a participant would normally receive at the clinic and generally includes individual and/or 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 participants may have with addiction and/or demonstrating new ways of coping with skills designed to fit their lifestyle. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week. | 34 |
| Individual Clinician-provided CBT This is individual treatment provided by a trained Cognitive Behavioral Therapy (CBT) clinician who will focus on teaching skills to understand and change participants behaviors to help them avoid alcohol use. Sessions with the clinician will generally last for 1 hour one time per week for 8 weeks. Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
Individual clinician-provided CBT: Individual clinician-provided CBT | 32 |
| CBT4CBT 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. The CBT4CBT program will cover the same skills as the individual clinician-provided CBT, only here it will be done by a computer. Participants will be taught how to use the computer program by a staff member and will be asked to spend about 8 hours using the program (approximately one hour per week) at the clinic.Participants will also be asked to complete a brief questionnaire and to provide urine and breath specimens for alcohol and drug testing once each week.
CBT4CBT: CBT computer program assisted therapy | 33 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 0 | 0 |
| Overall Study | dropped out during treatment | 7 | 13 | 10 |
| Overall Study | Never initiated treatment | 5 | 3 | 1 |
Baseline characteristics
| Characteristic | Standard Treatment as Usual (TAU) | Individual Clinician-provided CBT | CBT4CBT | Total |
|---|---|---|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 14 | 45.3 years STANDARD_DEVIATION 12.6 | 46.8 years STANDARD_DEVIATION 11.6 | 45.5 years STANDARD_DEVIATION 12.7 |
| Audit Score | 20.7 units on a scale STANDARD_DEVIATION 9 | 21.4 units on a scale STANDARD_DEVIATION 8.6 | 23.9 units on a scale STANDARD_DEVIATION 6.3 | 22 units on a scale STANDARD_DEVIATION 8.1 |
| Audit Score 16 or higher | 25 Participants | 24 Participants | 28 Participants | 77 Participants |
| AUD Severity Rating Mild | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| AUD Severity Rating Moderate | 8 Participants | 7 Participants | 7 Participants | 22 Participants |
| AUD Severity Rating Severe | 23 Participants | 24 Participants | 25 Participants | 72 Participants |
| Completed High School | 32 Participants | 31 Participants | 27 Participants | 90 Participants |
| Lifetime anxiety disorder | 3 Participants | 4 Participants | 8 Participants | 15 Participants |
| Lifetime major depression | 7 Participants | 12 Participants | 10 Participants | 29 Participants |
| Mean days of alcohol use during the past 28 days | 14.2 days STANDARD_DEVIATION 7.8 | 12.8 days STANDARD_DEVIATION 8.6 | 14.5 days STANDARD_DEVIATION 9.2 | 13.8 days STANDARD_DEVIATION 8.5 |
| Mean days of heavy drinking during the past 28 days | 8.9 days STANDARD_DEVIATION 8.1 | 9.1 days STANDARD_DEVIATION 8.4 | 10.8 days STANDARD_DEVIATION 9 | 9.6 days STANDARD_DEVIATION 8.5 |
| Mean number of Drinks per drinking day during the past 28 days | 6.3 drinks per drinking day STANDARD_DEVIATION 4 | 7.1 drinks per drinking day STANDARD_DEVIATION 4 | 8.7 drinks per drinking day STANDARD_DEVIATION 8 | 7.4 drinks per drinking day STANDARD_DEVIATION 5.7 |
| Mean number of Years of regular alcohol use | 20.1 years STANDARD_DEVIATION 13.8 | 22 years STANDARD_DEVIATION 13.2 | 18.8 years STANDARD_DEVIATION 12.7 | 20.3 years STANDARD_DEVIATION 13.2 |
| never married/living alone | 27 Participants | 24 Participants | 25 Participants | 76 Participants |
| On probation/ court referred | 16 Participants | 11 Participants | 7 Participants | 34 Participants |
| pre-treatment SCID Alcohol Symptom Count | 7.1 symptoms STANDARD_DEVIATION 2.7 | 7.8 symptoms STANDARD_DEVIATION 2.4 | 8.6 symptoms STANDARD_DEVIATION 2.9 | 7.8 symptoms STANDARD_DEVIATION 2.7 |
| Race/Ethnicity, Customized Ethnicity Hispanic | 9 Participants | 3 Participants | 7 Participants | 19 Participants |
| Race/Ethnicity, Customized Ethnicity Minority | 22 Participants | 16 Participants | 18 Participants | 56 Participants |
| Race/Ethnicity, Customized Ethnicity Unknkown | 3 Participants | 13 Participants | 8 Participants | 24 Participants |
| Race/Ethnicity, Customized Race African-American | 16 Participants | 13 Participants | 10 Participants | 39 Participants |
| Race/Ethnicity, Customized Race Caucasian | 13 Participants | 17 Participants | 17 Participants | 47 Participants |
| Race/Ethnicity, Customized Race Marked Hispanic only | 3 Participants | 1 Participants | 4 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Multiracial | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Unknown | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 34 participants | 32 participants | 33 participants | 99 participants |
| Sex: Female, Male Female | 12 Participants | 7 Participants | 14 Participants | 33 Participants |
| Sex: Female, Male Male | 22 Participants | 25 Participants | 19 Participants | 66 Participants |
| Unemployed | 21 Participants | 17 Participants | 21 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 34 | 0 / 32 | 0 / 33 |
| other Total, other adverse events | 0 / 34 | 0 / 32 | 0 / 33 |
| serious Total, serious adverse events | 8 / 34 | 1 / 32 | 7 / 33 |
Outcome results
Primary
Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back
The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure change over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use summarized monthly.
Time frame: from end of treatment at week 8 up to 6 months
Population: Intention to treat process was used for data collection. All randomized participants were tracked and follow up data collection was attempted for the 6 months post treatment. Contact attempts were at 1 month, 3 month and 6 month post treatment. Analysis population numbers start at the number of randomized participants that completed the 1 month post treatment interview. Months 2 and 3 numbers reflex number of randomized participants that attended the 3 month post treatment interview and so on.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Treatment as Usual (TAU) | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 1 | 66.71 percentage of days abstinent | Standard Deviation 32.06 |
| Standard Treatment as Usual (TAU) | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 4 | 67.70 percentage of days abstinent | Standard Deviation 36.48 |
| Standard Treatment as Usual (TAU) | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 3 | 55.14 percentage of days abstinent | Standard Deviation 37.53 |
| Standard Treatment as Usual (TAU) | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | End of Treatment | 69.26 percentage of days abstinent | Standard Deviation 26.18 |
| Standard Treatment as Usual (TAU) | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 6 | 69.57 percentage of days abstinent | Standard Deviation 34.39 |
| Standard Treatment as Usual (TAU) | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 5 | 68.17 percentage of days abstinent | Standard Deviation 37.16 |
| Standard Treatment as Usual (TAU) | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 2 | 63.86 percentage of days abstinent | Standard Deviation 35.61 |
| Individual Clinician-provided CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 3 | 68.12 percentage of days abstinent | Standard Deviation 33.15 |
| Individual Clinician-provided CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | End of Treatment | 68.10 percentage of days abstinent | Standard Deviation 29.85 |
| Individual Clinician-provided CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 1 | 75.86 percentage of days abstinent | Standard Deviation 29.29 |
| Individual Clinician-provided CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 2 | 71.96 percentage of days abstinent | Standard Deviation 30.91 |
| Individual Clinician-provided CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 4 | 63.74 percentage of days abstinent | Standard Deviation 35.9 |
| Individual Clinician-provided CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 5 | 68.27 percentage of days abstinent | Standard Deviation 37.13 |
| Individual Clinician-provided CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 6 | 70.19 percentage of days abstinent | Standard Deviation 35.11 |
| CBT4CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 4 | 82.14 percentage of days abstinent | Standard Deviation 23.07 |
| CBT4CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 1 | 74.74 percentage of days abstinent | Standard Deviation 32.64 |
| CBT4CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 6 | 82.59 percentage of days abstinent | Standard Deviation 25.26 |
| CBT4CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 5 | 85.12 percentage of days abstinent | Standard Deviation 23.66 |
| CBT4CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 3 | 82.55 percentage of days abstinent | Standard Deviation 22.84 |
| CBT4CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | Follow Up Month 2 | 77.06 percentage of days abstinent | Standard Deviation 28.59 |
| CBT4CBT | Percentage of Days Abstinent From Alcohol Use During 6-month Follow-up Period as Measured by Timeline Follow Back | End of Treatment | 73.28 percentage of days abstinent | Standard Deviation 25.03 |
p-value: 0.14Regression, Linear
Primary
Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back
The Timeline Follow Back is a calendar-based questionnaire used to assess alcohol use-consumption variables and can be used to measure alcohol use over time. This outcome was updated upon results entry. Presented are the percent days abstinent from alcohol use.
Time frame: Baseline up to 8 weeks
Population: Intention to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Treatment as Usual (TAU) | Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back | Week 4 | 63.25 percentage of days abstinent | Standard Deviation 29.81 |
| Standard Treatment as Usual (TAU) | Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back | Baseline | 49.26 percentage of days abstinent | Standard Deviation 27.84 |
| Standard Treatment as Usual (TAU) | Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back | Week 8 | 69.26 percentage of days abstinent | Standard Deviation 26.18 |
| Individual Clinician-provided CBT | Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back | Week 4 | 69.93 percentage of days abstinent | Standard Deviation 29.42 |
| Individual Clinician-provided CBT | Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back | Baseline | 53.73 percentage of days abstinent | Standard Deviation 29.8 |
| Individual Clinician-provided CBT | Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back | Week 8 | 68.10 percentage of days abstinent | Standard Deviation 29.85 |
| CBT4CBT | Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back | Baseline | 47.57 percentage of days abstinent | Standard Deviation 31.82 |
| CBT4CBT | Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back | Week 8 | 75.12 percentage of days abstinent | Standard Deviation 25.08 |
| CBT4CBT | Percentage of Days Abstinent From Alcohol Use During Treatment as Measured by Timeline Follow Back | Week 4 | 71.07 percentage of days abstinent | Standard Deviation 28.24 |
p-value: 0.11Regression, Linear