NCT01642381

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

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

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 12, 2016

Status Verified

September 1, 2016

Enrollment Period

3.9 years

First QC Date

July 13, 2012

Last Update Submit

September 9, 2016

Conditions

Keywords

DrinkingAlcohol ProblemsAlcoholismModeration-Oriented TreatmentControlled DrinkingReduced DrinkingHeavy DrinkingProblematic DrinkingNon-Abstinence-based Drinking

Outcome Measures

Primary Outcomes (1)

  • 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.

    36 weeks

Study Arms (2)

Psychotherapy

ACTIVE COMPARATOR
Behavioral: Full Motivational Interviewing ("FMI")Behavioral: Spirit Only Motivational Interviewing ("SOMI")

Self-Change Control ("SCC")

NO INTERVENTION

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.)

Interventions

Relational and technical technical (directive) strategies in counselling sessions to significantly increase commitment strength to reduce drinking.

Psychotherapy

Empathic and non-directive counselling based on Rogerian psychotherapy model.

Psychotherapy

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Shore LIJ Health Systems

Great Neck, New York, 11021, United States

Location

MeSH Terms

Conditions

Alcohol-Related DisordersAlcoholismAlcohol Drinking

Interventions

Receptor-Like Protein Tyrosine Phosphatases, Class 2

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

Receptor-Like Protein Tyrosine PhosphatasesProtein Tyrosine PhosphatasesPhosphoric Monoester HydrolasesEsterasesHydrolasesEnzymesEnzymes and CoenzymesIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Jonathan Morgenstern, PhD

    North Shore LIJ Health Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 13, 2012

First Posted

July 17, 2012

Study Start

May 1, 2012

Primary Completion

April 1, 2016

Study Completion

August 1, 2016

Last Updated

September 12, 2016

Record last verified: 2016-09

Locations