- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01642381
Component Analysis for Motivational Interviewing
Study Overview
Status
Conditions
Detailed Description
Project Motion is a clinical research study for people seeking to reduce, but not stop their drinking. Individuals who qualify will receive a comprehensive assessment and brief individual psychotherapy at no cost. The study is being conducted by a team of scientists at Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute and is funded by the National Institutes of Health (NIH). Our offices are located next to Columbus Circle and we offer convenient hours for appointments.
The purpose of our study is to understand how brief psychotherapy helps people reduce alcohol consumption and drinking problems. For example, we know that some people can reduce drinking with little or no treatment, whereas others benefit from one-on-one psychotherapy. However, we do not know why this happens. Individuals who qualify and decide to participate will be assigned by chance to one of three conditions. Individuals assigned to the first two conditions will receive brief psychotherapy, beginning the first week of their participation in the study. Individuals in the third condition will receive feedback on their drinking and be asked to reduce their drinking with the aid of telephone self-monitoring for a period of 8 weeks. Individuals in the third condition will then receive psychotherapy as well. The delay of 8 weeks will allow us to understand how the psychotherapy works compared to how people change without counseling.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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Great Neck, New York, United States, 11021
- North Shore LIJ Health Systems
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Primary current diagnosis of Alcohol Use Disorder
- Meets DSM-IV criteria for inability to control or cut down on drinking
- Have an average weekly consumption of >24 standard drinks for men and >15 standard drinks for women
- Show no evidence of significant cognitive impairment
- Are willing to reduce drinking to non-hazardous levels
- Not seeking to quit drinking
- Agree not to seek additional substance abuse treatment during treatment period
- Fluent in English
Exclusion Criteria:
- Have a current DSM-IV diagnosis of drug dependence (other than nicotine/marijuana)
- Have a serious psychiatric illness (e.g., psychotic disorder, bipolar disorder, major depression) or substantial suicide or violence risk
- Have clinically severe alcoholism as evidenced by a history of significant medical problems associated with drinking, seizures or severe withdrawal symptoms, or an inpatient treatment episode for drinking
- Legally mandated to receive substance abuse treatment
- Sufficiently socially unstable as to preclude completion of study requirements (e.g., homeless)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Psychotherapy
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Relational and technical technical (directive) strategies in counselling sessions to significantly increase commitment strength to reduce drinking.
Empathic and non-directive counselling based on Rogerian psychotherapy model.
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No Intervention: Self-Change Control ("SCC")
SCC participants will be told that they should attempt to reduce their drinking over the course of 8 weeks.
(If unsuccessful, they will be offered Full Motivational Interviewing therapy sessions.)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time Line Follow Back
Time Frame: 36 weeks
|
Calendar-based method of recording drinking patterns.
Data will be aggregated into summary variables including sum of standard drinks, mean drinks per drinking day, and percent days heavy drinking at multiple time points.
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36 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan Morgenstern, PhD, North Shore LIJ Health Systems
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA 020077-01A1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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