Alcohol Abuse, Alcohol Use Disorder
Conditions
Brief summary
A small percentage of individuals with alcohol use disorder (AUD) obtain alcohol-related care despite research showing that treatment is effective. This randomized controlled trial tests the efficacy of a brief, phone based cognitive behavioral intervention to increase treatment engagement, improve alcohol related outcomes, and show that treatment engagement is a mechanism for the improved outcomes in individuals with AUD.
Interventions
BEHAVIORALCBT by Phone to Promote Treatment
Structured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles.
OTHERReading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment
The pamphlet was created by the National Institute on Alcohol Abuse and Alcoholism to describe evidence based treatments available for alcohol use disorder and how to obtain such treatment.
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Medical University of South Carolina
Syracuse University
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The University of Rochester based study team, led by MPI Conner, were masked to treatment assignment (which was performed at the Medical University of South Carolina), and the University of Rochester based team performed all follow-up assessments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 18-plus; * score ≥ 16 on AUDIT; * within the past 30 days, exceeding the limits for low-risk drinking adopted by NIAAA: \>3 standard drinks on any occasion or \>7 drinks per week (women); \>4 drinks on any occasion or \>14 drinks per week (men).
Exclusion criteria
* unable to communicate with the researcher in English; * unable to comprehend the nature of the study; * history of alcohol-related care; * alcohol withdrawal necessitating medical evaluation; * residency outside of The Greater Rochester Area.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Drinks Per Drinking Day | prior 30 days (at 3-month follow-up) | Average number of standard drinks on days of alcohol consumption at 3-month follow-up |
| Days Abstinent | prior 30 days (at 3-month follow-up) | Number of days abstinent from alcohol use in prior 30 days |
| Number Initiating Alcohol Use Disorder Treatment | over 3 months | Number Attending any Alcohol Use Disorder Treatment Session(s) over 3-month follow-up |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CBT Phone Intervention CBT by Phone to Promote Treatment: Structured phone intervention to identify concerns about getting alcohol use disorder treatment and to work through those concerns using cognitive behavioral principles. | 197 |
| Being Read A Pamphlet on Alcohol Treatment Reading the Subject a Pamphlet on Obtaining Alcohol Use Disorder Treatment: The pamphlet was created by the National Institute on Alcohol Abuse and Alcoholism to describe evidence based treatments available for alcohol use disorder and how to obtain such treatment. | 203 |
| Total | 400 |
Baseline characteristics
| Characteristic | CBT Phone Intervention | Being Read A Pamphlet on Alcohol Treatment | Total |
|---|---|---|---|
| Age, Continuous | 40.3 years STANDARD_DEVIATION 10.5 | 41.1 years STANDARD_DEVIATION 10.9 | 40.7 years STANDARD_DEVIATION 10.7 |
| Average Drinks Per Drinking Day (in past 30 days) | 6.7 standard drinks STANDARD_DEVIATION 3.7 | 6.7 standard drinks STANDARD_DEVIATION 3.5 | 6.7 standard drinks STANDARD_DEVIATION 3.6 |
| Days Abstinent (in past 30 days) | 8.5 days (scale 0-30) STANDARD_DEVIATION 7.7 | 8.1 days (scale 0-30) STANDARD_DEVIATION 7.3 | 8.3 days (scale 0-30) STANDARD_DEVIATION 7.5 |
| Number Initiating Alcohol Use Disorder Treatment | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 6 Participants | 9 Participants |
| Race/Ethnicity, Customized Black | 26 Participants | 27 Participants | 53 Participants |
| Race/Ethnicity, Customized Hispanic ethnicity (across races) | 12 Participants | 16 Participants | 28 Participants |
| Race/Ethnicity, Customized More than one race | 8 Participants | 8 Participants | 16 Participants |
| Race/Ethnicity, Customized Native American-Alaskan Native | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other race | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 158 Participants | 159 Participants | 317 Participants |
| Region of Enrollment United States | 197 participants | 203 participants | 400 participants |
| Sex: Female, Male Female | 107 Participants | 92 Participants | 199 Participants |
| Sex: Female, Male Male | 90 Participants | 111 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 197 | 0 / 203 |
| other Total, other adverse events | 0 / 197 | 1 / 203 |
| serious Total, serious adverse events | 0 / 197 | 0 / 203 |
Outcome results
Primary
Average Drinks Per Drinking Day
Average number of standard drinks on days of alcohol consumption at 3-month follow-up
Time frame: prior 30 days (at 3-month follow-up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT Phone Intervention | Average Drinks Per Drinking Day | 5.5 drinks per occasion | Standard Deviation 3.8 |
| Being Read A Pamphlet on Alcohol Treatment | Average Drinks Per Drinking Day | 5.4 drinks per occasion | Standard Deviation 3.5 |
p-value: 0.746Based on simple path model in Mplus.
Primary
Days Abstinent
Number of days abstinent from alcohol use in prior 30 days
Time frame: prior 30 days (at 3-month follow-up)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CBT Phone Intervention | Days Abstinent | 15.5 Days abstinent (in past 30 days) | Standard Deviation 10.5 |
| Being Read A Pamphlet on Alcohol Treatment | Days Abstinent | 14.6 Days abstinent (in past 30 days) | Standard Deviation 9.9 |
p-value: 0.247Based on simple path model in Mplus.
Primary
Number Initiating Alcohol Use Disorder Treatment
Number Attending any Alcohol Use Disorder Treatment Session(s) over 3-month follow-up
Time frame: over 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CBT Phone Intervention | Number Initiating Alcohol Use Disorder Treatment | 38 Participants |
| Being Read A Pamphlet on Alcohol Treatment | Number Initiating Alcohol Use Disorder Treatment | 36 Participants |
p-value: 0.689Chi-squared