Adaptive Interventions for Problem Drinkers

Not Applicable

Completed

• Conditions: Alcohol Use Disorders; Alcohol Drinking; Alcoholism; Alcohol-Related Disorders; Alcohol Abuse
• Interventions: Behavioral: Motivational Interviewing; Behavioral: Brief Advice; Behavioral: Behavioral Self-Control Training

• Registration Number: NCT02511808
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-07-10
• Study First Submitted QC: 2015-07-27
• Study First Posted: 2015-07-30
• Primary Completion: 2019-03
• Study Completion: 2019-05
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-09
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Step-up Treatment: MI	Motivational Interviewing	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.
Control: BA	Brief Advice	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.
Step-up Treatment: Specialist Care	Motivational Interviewing	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.
Control: MI	Motivational Interviewing	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.
Step-up Treatment: Specialist Care	Behavioral Self-Control Training	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.

Primary Outcome Measures

Name	Time	Method
Time Line Follow Back	24 Weeks	Calendar-based method of recording drinking patterns. Data will be aggregated into summary variables.

Trial Locations

Locations (1)

Northwell Health; 🇺🇸 Great Neck, New York, United States