Project Motion, A Study of Motivational Interviewing to Reduce Heavy or Problematic Drinking - Full Text View

Sponsored by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00665249

Purpose

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

Condition	Intervention
Heavy or Problematic Drinking	Behavioral: Motivational Interviewing Behavioral: Non-directive psychotherapy Other: Waitlist control

Drug Information available for: Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Component Analysis of Motivational Interviewing

Further study details as provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Quantity of alcohol use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Frequency of binge drinking [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	April 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 4 sessions of full motivational interviewing	Behavioral: Motivational Interviewing See www.motivationalinterviewing.org
2: Active Comparator 4 sessions of non-directive Rogerian components of motivational interviewing only	Behavioral: Non-directive psychotherapy Non-directive elements encompass the use of MI consistent and avoidance of MI inconsistent behaviors as well as attention to MI spirit and are well articulated in MI manuals (Miller et al., 1992) and therapist coding schemes. Non-specific or common factors are comprised of placebo/expectancy effects associated with receiving any treatment as well as Rogerian factors such as empathy and therapist genuineness.
3: Placebo Comparator Delayed 8 weeks, then 4 session receive full motivational interviewing.	Other: Waitlist control Participants are followed for 8 weeks, without therapeutic intervention. At end of assessment period, they receive 4 sessions of full MI.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665249

Contacts

Contact: Lisa A Hail, BA	212-974-0494	projectmotion@gmail.com
Contact: Alexis N Kuerbis, MSW	212-974-0535	Kuerbis@pi.cpmc.columbia.edu

Locations

United States, New York
Research Foundation for Mental Hygiene, Inc., Columbia Addiction Services and Psychotherapy Intervention Research	Recruiting
New York, New York, United States, 10019
Contact: Lisa Hail, BA 212-974-0494 projectmotion@gmail.com
Contact: Alexis N Kuerbis, MSW 212-974-0535 Kuerbis@pi.cpmc.columbia.edu
Principal Investigator: Jon Morgenstern, Ph.D.

Sponsors and Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:	Jon Morgenstern, Ph.D.	Columbia University
Study Director:	Alexis N Kuerbis, MSW	Research Foundation for Mental Hygiene, Inc.

More Information

Project Motion This link exits the ClinicalTrials.gov site

Responsible Party:	Columbia University ( Jon Morgenstern, Ph.D. )
Study ID Numbers:	R21 AA 017135-01, R21 AA 017135-01
Study First Received:	April 21, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00665249
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

heavy drinking
Alcohol
moderation
motivational interviewing

Study placed in the following topic categories:

Ethanol

ClinicalTrials.gov processed this record on January 16, 2009