Adaptive Interventions for Problem Drinkers

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Adaptive Interventions for Problem Drinkers

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

Intervention / Treatment
-----------------
* Behavioral: Brief Advice
* Behavioral: Motivational Interviewing
* Behavioral: Behavioral Self-Control Training


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Step-up Treatment: MI<br>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. | Behavioral: Motivational Interviewing<br>* 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.<br>|
| Other: Control: BA<br>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. | Behavioral: Brief Advice<br>* 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.<br>|
| Active Comparator: Step-up Treatment: Specialist Care<br>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. | Behavioral: Motivational Interviewing<br>* 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.<br>Behavioral: Behavioral Self-Control Training<br>* 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.<br>|
| Other: Control: MI<br>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. | Behavioral: Motivational Interviewing<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Line Follow Back | Calendar-based method of recording drinking patterns. Data will be aggregated into summary variables. | 24 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Drinking, Alcohol Problems, Alcoholism, Reduced Drinking, Problematic Drinking, Non-Abstinence-based Drinking, Controlled Drinking, Heavy Drinking