Adaptive Interventions for Problem Drinkers
2 other identifiers
interventional
164
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 10, 2015
CompletedFirst Posted
Study publicly available on registry
July 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedSeptember 11, 2020
September 1, 2020
4 years
July 10, 2015
September 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time Line Follow Back
Calendar-based method of recording drinking patterns. Data will be aggregated into summary variables.
24 Weeks
Study Arms (4)
Step-up Treatment: MI
ACTIVE COMPARATORAfter 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
OTHERAfter 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
ACTIVE COMPARATORAfter 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
OTHERAfter 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.
Interventions
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.
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 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.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwell Health
Great Neck, New York, 11021, United States
Related Publications (1)
Kuerbis AN, Shao S, Treloar Padovano H, Jadanova A, Selva Kumar D, Vitale R, Nitzburg G, Vadhan NP, Morgenstern J. Context and craving among individuals with alcohol use disorder attempting to moderate their drinking. Exp Clin Psychopharmacol. 2020 Dec;28(6):677-687. doi: 10.1037/pha0000349. Epub 2020 Jan 23.
PMID: 31971419BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Morgenstern, Ph.D.
Northwell Health
- STUDY DIRECTOR
Nehal P Vadhan
Northwell Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Addiction Services
Study Record Dates
First Submitted
July 10, 2015
First Posted
July 30, 2015
Study Start
March 1, 2015
Primary Completion
March 1, 2019
Study Completion
May 1, 2019
Last Updated
September 11, 2020
Record last verified: 2020-09