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Component Analysis for Motivational Interviewing

Primary Purpose

Alcohol-Related Disorders, Alcohol Use Disorders, Alcohol Drinking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Full Motivational Interviewing ("FMI")
Spirit Only Motivational Interviewing ("SOMI")
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol-Related Disorders focused on measuring Drinking, Alcohol Problems, Alcoholism, Moderation-Oriented Treatment, Controlled Drinking, Reduced Drinking, Heavy Drinking, Problematic Drinking, Non-Abstinence-based Drinking

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • North Shore LIJ Health Systems

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Psychotherapy

Self-Change Control ("SCC")

Arm Description

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.)

Outcomes

Primary Outcome Measures

Time Line Follow Back
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.

Secondary Outcome Measures

Full Information

First Posted
July 13, 2012
Last Updated
September 9, 2016
Sponsor
Northwell Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01642381
Brief Title
Component Analysis for Motivational Interviewing
Official Title
Component Analysis for Motivational Interviewing
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to investigate the critical components of motivational interviewing (MI), a psychotherapeutic intervention, in reducing heavy or problematic drinking. The study will disaggregate MI into its component parts and test full MI compared to MI without its directive strategies. This study will test whether the directive elements of MI are critical or whether MI effects may be attributable solely to its Rogerian, non-directive components. For more information, go to http://caspirnyc.org/p_motion.html
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Disorders, Alcohol Use Disorders, Alcohol Drinking, Alcoholism, Alcohol Abuse
Keywords
Drinking, Alcohol Problems, Alcoholism, Moderation-Oriented Treatment, Controlled Drinking, Reduced Drinking, Heavy Drinking, Problematic Drinking, Non-Abstinence-based Drinking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Psychotherapy
Arm Type
Active Comparator
Arm Title
Self-Change Control ("SCC")
Arm Type
No Intervention
Arm Description
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.)
Intervention Type
Behavioral
Intervention Name(s)
Full Motivational Interviewing ("FMI")
Intervention Description
Relational and technical technical (directive) strategies in counselling sessions to significantly increase commitment strength to reduce drinking.
Intervention Type
Behavioral
Intervention Name(s)
Spirit Only Motivational Interviewing ("SOMI")
Intervention Description
Empathic and non-directive counselling based on Rogerian psychotherapy model.
Primary Outcome Measure Information:
Title
Time Line Follow Back
Description
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.
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Morgenstern, PhD
Organizational Affiliation
North Shore LIJ Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Shore LIJ Health Systems
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Component Analysis for Motivational Interviewing

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