NCT00665249

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

1.1 years

First QC Date

April 21, 2008

Last Update Submit

April 27, 2015

Conditions

Keywords

problem drinkingheavy drinkingAlcoholmoderationmotivational interviewing

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks

Study Arms (3)

Full Motivational Interviewing

ACTIVE COMPARATOR

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.

Behavioral: Motivational Interviewing

No Intervention: Self Change

ACTIVE COMPARATOR

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.

Other: Self-Change

Spirit-Only Motivational Interviewing

ACTIVE COMPARATOR

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.

Behavioral: Spirit-Only Motivational Interviewing

Interventions

See MotivationalInterviewing.org

Also known as: 4 one-hour Psychotherapy Sessions over 8 weeks.
Full Motivational Interviewing

Non-directive elements encompass the use of MI-consistent, and avoidance of MI-inconsistent, behaviors, as well as attention to MI-spirit.

Also known as: SOMI, Non-Directive Psychotherapy
Spirit-Only Motivational Interviewing

Participants are followed for 8 weeks, without therapeutic intervention. At end of assessment period, they receive 4 sessions of full MI.

Also known as: Waitlist Control
No Intervention: Self Change

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

New York, New York, 10019, United States

Location

Related Links

MeSH Terms

Conditions

Alcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jon Morgenstern, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR
  • Alexis N Kuerbis, MSW, PhD

    Research Foundation for Mental Hygiene, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director, Substance Abuse Services

Study Record Dates

First Submitted

April 21, 2008

First Posted

April 23, 2008

Study Start

April 1, 2008

Primary Completion

May 1, 2009

Study Completion

July 1, 2009

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations