Adaptive Interventions for Problem Drinkers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-05-31

Brief Summary

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The purpose of this study is to understand how certain interventions help people reduce or quit their drinking and how certain interventions may help best at certain points in time in the change process.

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Detailed Description

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Problem drinkers (PDs) represent a majority of the estimated 32 million Americans with alcohol problems that spans a spectrum of severity from individuals who drink excessively and experience of occasional negative consequences to those with moderate Alcohol Dependence (AD) and intact psychosocial functioning. PDs can benefit from relatively brief treatment that could be delivered in mainstream healthcare, but less than 5% receive such care. In addition, PD treatment is only modestly effective, and there is a surprising absence of empirical research to guide PD treatment selection. Adaptive Interventions (AI) are a novel approach to treatment development that may have significant advantages over fixed treatments in improving efficacy and fostering adoption of Evidence Based Practices in mainstream healthcare. If study aims are achieved, a set of empirically-derived decision support tools will be created to guide Alcohol Use Disorders (AUD) care similar to tools that exist for other chronic diseases. In addition, new knowledge will be gained about Mechanisms of Behavior Change of AUD that can guide future AUD treatment research. Finally, important progress will be made in methods that capitalize on the remarkable advances in sensor technologies, advanced mathematics, and engineering to create a new type of tailored, near-real time feedback, adaptive behavior therapies.

Conditions

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Alcohol-Related Disorders Alcohol Use Disorders Alcohol Drinking Alcoholism Alcohol Abuse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Step-up Treatment: MI

After receiving one session of Brief Advice (BA), participants will be assessed at week 4 for response to this treatment. Those who are deemed non-responders to the BA will be randomly assigned to receive either Motivational Interviewing (MI) or more BA. In this arm, participants will receive two sessions of MI.

Group Type ACTIVE_COMPARATOR

Motivational Interviewing

Intervention Type BEHAVIORAL

Motivational Interviewing will consist of standard techniques, such as developing discrepancy, enhancing motivation, and developing a change plan, that have been adapted to treatment for problem drinkers.

Control: BA

After receiving one session of Brief Advice (BA), participants will be assessed at week 4 for response to this treatment. Those who are deemed non-responders to the BA will be randomly assigned to receive either Motivational Interviewing (MI) or more BA. In this arm, participants will receive one additional session of BA.

Group Type OTHER

Brief Advice

Intervention Type BEHAVIORAL

Brief Advice (BA) consists of a 20-minute session delivered by a study therapist, adhering to the NIAAA's Clinician Guide to Problem Drinkers. It includes personalized, normative feedback based on NIAAA drinking norms, goal selection, instructions on self-monitoring, discussion of drink reduction strategies, and distribution of the NIAAA bibliotherapy guide.

Step-up Treatment: Specialist Care

After receiving one session of Brief Advice (BA) and two sessions of Motivational Interviewing (MI) or one session of BA over the first 8 weeks of the study, participants will be assessed at week 8 for response to this treatment. Those who are deemed non-responders will be randomly assigned to receive Behavioral Self-Control Training (BSCT) or more MI if they were randomized to MI at week 4 or five sessions of combined MI and BSCT or one more session of MI if they were randomized to BA at week 4. In this arm, participants will receive four sessions of BSCT if they received MI at the previous randomization or five sessions of combined MI and BSCT if they received BA at the previous randomization.

Group Type ACTIVE_COMPARATOR

Motivational Interviewing

Intervention Type BEHAVIORAL

Motivational Interviewing will consist of standard techniques, such as developing discrepancy, enhancing motivation, and developing a change plan, that have been adapted to treatment for problem drinkers.

Behavioral Self-Control Training

Intervention Type BEHAVIORAL

Behavioral Self-Control Training will consist of Cognitive Behavioral Therapy adapted to problem drinkers, whose core components include a functional analysis, skills training, daily self-monitoring, homework, and graded exposures and mastery of high risk situations.

Control: MI

After receiving one session of Brief Advice (BA) and two sessions of Motivational Interviewing (MI) or one session of BA over the first 8 weeks of the study, participants will be assessed at week 8 for response to this treatment. Those who are deemed non-responders will be randomly assigned to receive Behavioral Self-Control Training (BSCT) or more MI if they were randomized to MI at week 4 or five sessions of combined MI and BSCT or one more session of MI if they were randomized to BA at week 4. In this arm, participants will receive one session of MI if they received MI at the previous randomization or two sessions of MI if they received BA at the previous randomization.

Group Type OTHER

Motivational Interviewing

Intervention Type BEHAVIORAL

Motivational Interviewing will consist of standard techniques, such as developing discrepancy, enhancing motivation, and developing a change plan, that have been adapted to treatment for problem drinkers.

Interventions

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Brief Advice

Brief Advice (BA) consists of a 20-minute session delivered by a study therapist, adhering to the NIAAA's Clinician Guide to Problem Drinkers. It includes personalized, normative feedback based on NIAAA drinking norms, goal selection, instructions on self-monitoring, discussion of drink reduction strategies, and distribution of the NIAAA bibliotherapy guide.

Intervention Type BEHAVIORAL

Motivational Interviewing

Motivational Interviewing will consist of standard techniques, such as developing discrepancy, enhancing motivation, and developing a change plan, that have been adapted to treatment for problem drinkers.

Intervention Type BEHAVIORAL

Behavioral Self-Control Training

Behavioral Self-Control Training will consist of Cognitive Behavioral Therapy adapted to problem drinkers, whose core components include a functional analysis, skills training, daily self-monitoring, homework, and graded exposures and mastery of high risk situations.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

Primary Inclusion Criteria: Adults who have heavy weekly alcohol consumption (and/or an alcohol use disorder) and are willing to reduce their drinking.

Primary Exclusion Criteria: Adults for whom the level of treatment provided is not appropriate and/or who require more intensive substance use or psychiatric treatment.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No