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Project Motion, A Study of Motivational Interviewing to Reduce Heavy or Problematic Drinking

Primary Purpose

Alcohol Dependence, Alcohol Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Spirit-Only Motivational Interviewing
Self-Change
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence focused on measuring problem drinking, heavy drinking, Alcohol, moderation, motivational interviewing

Eligibility Criteria

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

Inclusion Criteria:

  • age 18-65
  • primary current diagnosis of alcohol use disorder
  • have an average weekly consumption of >24 standard drinks (A standard drink is defined as 1.5 oz of 80 proof distilled spirits, a 5 oz. glass of wine, or a 12 oz. beer. These are all estimated to have about 0.5 oz or 9 grams of pure ethanol.)
  • able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment
  • are willing to reduce drinking to non-hazardous levels
  • are willing to provide signed informed consent to participate
  • agree not to seek additional substance abuse treatment during study period

Exclusion Criteria:

  • have significant current substance use or substance dependence (with the exception of marijuana, nicotine and caffeine),defined as, any substance use (with the exception of marijuana, nicotine and caffeine) greater than weekly use in the past month
  • have a serious psychiatric illness (e.g., psychotic disorder, bipolar disorder, major depression, etc.) or substantial suicide or violence risk
  • having clinically severe alcoholism as evidenced by a history of significant medical problems associated with drinking, a history of seizures or severe withdrawal symptoms, or more than one 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)
  • state desire to pursue a goal of lifetime abstinence
  • report current participation in or report an intent to participate in an additional substance abuse treatment method during the course of the study
  • stated desire or intent to become pregnant or stated inconsistent use of birth control while sexually active

Sites / Locations

  • Research Foundation for Mental Hygiene, Inc., Columbia Addiction Services and Psychotherapy Intervention Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Full Motivational Interviewing

No Intervention: Self Change

Spirit-Only Motivational Interviewing

Arm Description

This condition consisted of all the standard elements of MI, both the non-directive and directive strategies (Miller & Rollnick, 2002). Rogerian elements, such as warmth, egalitarianism, genuineness, and a client-centered approach to the therapeutic relationship, are commonly referred to as "MI Spirit" (Moyers, Martin, Manual, Hendricksen, & Miller, 2005). MI is comprised of MI spirit and includes specific directive strategies geared to focus the client toward targeted behavior change, such as confidence and importance rulers, visualization of behavior change, or a decisional balance. The directive elements of MI are those that selectively reinforce positive change talk or enhance discrepancy between a client's wish to change and stay with the status quo.

Participants in this condition were not assigned to treatment, but were asked to attempt to change on their own during the 8-week follow-up period. SC participants were told that research had shown that some individuals could reduce their drinking without professional help; that participating in the IVR might facilitate their efforts; and that they would be offered professional treatment at the end of the 8-week period. As noted in the Introduction, SC was selected rather than a traditional wait-list control because the aim of the study was to decompose MI into its 3 hypothesized components that include self-change.

While this condition retained the Rogerian elements to MI, directive elements were excluded. For example, SOMI consisted of the non-directive elements including therapist stance (warmth, genuineness, egalitarianism), emphasis on client responsibility to change, extensive use of reflective listening skills (e.g., open-ended questions, simple reflections), and avoidance of MI-inconsistent behaviors (advise, confront, take expert role, interpretation). Reflective listening was focused on the whole experience of the client and the client's affect, and targeting a particular behavior or eliciting change talk about drinking was proscribed. Furthermore, tools utilized frequently in MI to develop discrepancy, such as amplified or double-sided reflections, were proscribed.

Outcomes

Primary Outcome Measures

Timeline Followback (TLFB)--Measures frequency and intensity of drinking by self-report
Daily record of drinking--measured in standard drink equivalents. The TLFB (Sobell, et al, 1980) assesses frequency of alcohol use during the previous 8 weeks. TLFB data is aggregated to provide weekly summary variables (sum of standard drinks per week, mean drinks per drinking day, and the mean number of drinking days) across the 8 weeks prior to randomization through the end of treatment. In order to compare baseline drinking, weekly summary variables were averaged across the 8 weeks prior to randomization.

Secondary Outcome Measures

Full Information

First Posted
April 21, 2008
Last Updated
April 27, 2015
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT00665249
Brief Title
Project Motion, A Study of Motivational Interviewing to Reduce Heavy or Problematic Drinking
Official Title
Component Analysis of Motivational Interviewing
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this pilot 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 www.projectmotion.org
Detailed Description
Motivational interviewing (MI) has been demonstrated to be an effective intervention for alcohol use disorders (AUD). The consistency, magnitude, and durability of its effects suggest powerful mechanisms of behavior change (MOBC) operate to reduce drinking. A better understanding of the MOBC in MI is therefore important. Existing MOBC studies of MI have yielded limited and contradictory findings. The project proposes to conduct a small pilot study to disaggregate MI into its component parts and test full MI compared to MI without its directive strategies. This test will compare whether the directive elements of MI (Full MI, or FMI) are critical or whether MI effects may be attributable solely to its Rogerian, non-directive components (aka, Spirit-Only MI, or SOMI). In addition, we will test whether hypothesized main effects of FMI are mediated via increases in commitment to reduce drinking early in treatment. Further, we will examine whether non-specific therapy factors alone (SOMI) significantly reduce drinking when compared to a Feedback Followed by Counseling (FFC) condition that controls for non-therapy factors and incorporates assessment and self-monitoring. We will also test whether SOMI's main effects are mediated by increases in mood and greater belief in the ability to change, as hypothesized by various theories. Our work on MOBC for MI will take place in the context of studying brief, stand-alone treatments for individuals with primary AUD who seek to reduce, but not stop, drinking. We will recruit 90 individuals with AUD seeking treatment; collect daily process data during a pre-treatment week; and then assess and randomly assign them to 3 conditions: FMI, SOMI, and FFC. All participants will be followed for 9 weeks using daily Interactive Voice Recording (IVR) and in-laboratory assessments at weeks 0, 1, 4, and 8. Those in treatment conditions will receive 4 sessions of treatment at weeks 1, 2, 4, and 8. FFC will receive treatment after completing the week 8 assessment period. Participants in FMI and SOMI will be followed for an additional 4 weeks post-treatment (week 12).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Alcohol Abuse
Keywords
problem drinking, heavy drinking, Alcohol, moderation, motivational interviewing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Full Motivational Interviewing
Arm Type
Active Comparator
Arm Description
This condition consisted of all the standard elements of MI, both the non-directive and directive strategies (Miller & Rollnick, 2002). Rogerian elements, such as warmth, egalitarianism, genuineness, and a client-centered approach to the therapeutic relationship, are commonly referred to as "MI Spirit" (Moyers, Martin, Manual, Hendricksen, & Miller, 2005). MI is comprised of MI spirit and includes specific directive strategies geared to focus the client toward targeted behavior change, such as confidence and importance rulers, visualization of behavior change, or a decisional balance. The directive elements of MI are those that selectively reinforce positive change talk or enhance discrepancy between a client's wish to change and stay with the status quo.
Arm Title
No Intervention: Self Change
Arm Type
Active Comparator
Arm Description
Participants in this condition were not assigned to treatment, but were asked to attempt to change on their own during the 8-week follow-up period. SC participants were told that research had shown that some individuals could reduce their drinking without professional help; that participating in the IVR might facilitate their efforts; and that they would be offered professional treatment at the end of the 8-week period. As noted in the Introduction, SC was selected rather than a traditional wait-list control because the aim of the study was to decompose MI into its 3 hypothesized components that include self-change.
Arm Title
Spirit-Only Motivational Interviewing
Arm Type
Active Comparator
Arm Description
While this condition retained the Rogerian elements to MI, directive elements were excluded. For example, SOMI consisted of the non-directive elements including therapist stance (warmth, genuineness, egalitarianism), emphasis on client responsibility to change, extensive use of reflective listening skills (e.g., open-ended questions, simple reflections), and avoidance of MI-inconsistent behaviors (advise, confront, take expert role, interpretation). Reflective listening was focused on the whole experience of the client and the client's affect, and targeting a particular behavior or eliciting change talk about drinking was proscribed. Furthermore, tools utilized frequently in MI to develop discrepancy, such as amplified or double-sided reflections, were proscribed.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Other Intervention Name(s)
4 one-hour Psychotherapy Sessions over 8 weeks.
Intervention Description
See MotivationalInterviewing.org
Intervention Type
Behavioral
Intervention Name(s)
Spirit-Only Motivational Interviewing
Other Intervention Name(s)
SOMI, Non-Directive Psychotherapy
Intervention Description
Non-directive elements encompass the use of MI-consistent, and avoidance of MI-inconsistent, behaviors, as well as attention to MI-spirit.
Intervention Type
Other
Intervention Name(s)
Self-Change
Other Intervention Name(s)
Waitlist Control
Intervention Description
Participants are followed for 8 weeks, without therapeutic intervention. At end of assessment period, they receive 4 sessions of full MI.
Primary Outcome Measure Information:
Title
Timeline Followback (TLFB)--Measures frequency and intensity of drinking by self-report
Description
Daily record of drinking--measured in standard drink equivalents. The TLFB (Sobell, et al, 1980) assesses frequency of alcohol use during the previous 8 weeks. TLFB data is aggregated to provide weekly summary variables (sum of standard drinks per week, mean drinks per drinking day, and the mean number of drinking days) across the 8 weeks prior to randomization through the end of treatment. In order to compare baseline drinking, weekly summary variables were averaged across the 8 weeks prior to randomization.
Time Frame
8 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: age 18-65 primary current diagnosis of alcohol use disorder have an average weekly consumption of >24 standard drinks (A standard drink is defined as 1.5 oz of 80 proof distilled spirits, a 5 oz. glass of wine, or a 12 oz. beer. These are all estimated to have about 0.5 oz or 9 grams of pure ethanol.) able to read English at the eighth grade or higher level and show no evidence of significant cognitive impairment are willing to reduce drinking to non-hazardous levels are willing to provide signed informed consent to participate agree not to seek additional substance abuse treatment during study period Exclusion Criteria: have significant current substance use or substance dependence (with the exception of marijuana, nicotine and caffeine),defined as, any substance use (with the exception of marijuana, nicotine and caffeine) greater than weekly use in the past month have a serious psychiatric illness (e.g., psychotic disorder, bipolar disorder, major depression, etc.) or substantial suicide or violence risk having clinically severe alcoholism as evidenced by a history of significant medical problems associated with drinking, a history of seizures or severe withdrawal symptoms, or more than one 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) state desire to pursue a goal of lifetime abstinence report current participation in or report an intent to participate in an additional substance abuse treatment method during the course of the study stated desire or intent to become pregnant or stated inconsistent use of birth control while sexually active
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Morgenstern, Ph.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexis N Kuerbis, MSW, PhD
Organizational Affiliation
Research Foundation for Mental Hygiene, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Research Foundation for Mental Hygiene, Inc., Columbia Addiction Services and Psychotherapy Intervention Research
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.projectmotion.org
Description
Project Motion

Learn more about this trial

Project Motion, A Study of Motivational Interviewing to Reduce Heavy or Problematic Drinking

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