Clinical trial NCT00665249: Project Motion, A Study of Motivational Interviewing to Reduce Heavy or Problematic Drinking
Official title: Component Analysis of Motivational Interviewing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Alcohol Abuse
Keywords: problem drinking
heavy drinking
Alcohol
moderation
motivational interviewing
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2008-04-23
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Timeline Followback (TLFB)--Measures frequency and intensity of drinking by self-report
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Foundation for Mental Hygiene, Inc., Columbia Addiction Services and Psychotherapy Intervention Research
state: New York
Study officials:
affiliation: Columbia University
name: Jon Morgenstern, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Foundation for Mental Hygiene, Inc.
name: Alexis N Kuerbis, MSW, PhD
role: STUDY_DIRECTOR
References: