Randomized Trial of Intensive Motivational Interviewing (IMI) to Improve Drinking Outcomes Among Women
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|ClinicalTrials.gov Identifier: NCT02272023|
Recruitment Status : Completed
First Posted : October 22, 2014
Last Update Posted : September 18, 2019
A Phase II Randomized Clinical Trial (RCT) is proposed to compare a 9-session model of intensive motivational interviewing (IMI) to standard motivational interviewing techniques (SMI) among alcohol dependent women. Preliminary work studying 87 women randomly assigned to IMI or a standard single session of motivational interviewing showed significantly better drinking outcomes for women in the IMI condition at 4- and 6-month follow-up. Interestingly, mean trajectories for women assigned to IMI showed continuing declines in drinking problems during and after treatment. Differences between study conditions grew larger between 4-month (p<.05) and 6-month (p<.01) follow-up and the effect size at 6 months was medium to large (Cohen's d=0.63) The study will use mixed model quantitative and qualitative methods to respond to the PA's call for studies assessing mechanisms of change. Unlike many previous studies of SMI, we will employ limited exclusion criteria and will enroll participants who present with co-existing drug and psychiatric disorders.
Procedures for the proposed study draw from our current successful RCT assessing IMI for methamphetamine (MA) dependence. Successful aspects of the current study include achievement of recruitment goals, strong adherence to the treatment and research protocols, and excellent rates for follow-up interviews (>90%). The proposed study will take place at the same outpatient treatment program as the current study, New Leaf Treatment Center in Lafayette, California.
Participants will include 220 alcohol dependent women who will be randomly assigned to IMI or SMI. Those in SMI will also receive an attention component (nutrition education) to achieve time equivalence between the two study conditions. Participants in both groups will receive standard weekly group treatment offered at the program. In addition, referrals to Alcoholics Anonymous will be provided to all participants. The primary outcomes will be measures of drinking, heavy drinking (4+ drinks), and severity of alcohol problems assessed at baseline and 2, 6, and 12 months. Secondary outcomes will include Addiction Severity Index scales, psychiatric problems, and symptoms of trauma. The study will include standard quantitative testing of potential mediators, including, the therapeutic alliance, self-efficacy, motivation, satisfaction, and use of outside services. However, the application also proposes an innovative use of qualitative procedures to identify unrecognized factors influencing outcome.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorders||Behavioral: Intensive Motivational Interviewing Behavioral: Single session of Motivational Interviewing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||215 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial of Intensive Motivational Interviewing (IMI) to Improve Drinking Outcomes Among Women|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||March 2019|
|Actual Study Completion Date :||March 7, 2019|
Experimental: 9 sessions of Intensive Motivational Interviewing
Experimental condition will consist of 9 1-hour intensive motivational interviewing sessions.
Behavioral: Intensive Motivational Interviewing
Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education.
Active Comparator: 1 Standard Motivational Interview plus 8 nutrition classes
The standard MI intervention will consist of a commonly used, single session of MI (50 minutes) plus 8 hours of nutrition education to achieve time and attention equivalence of study conditions.
Behavioral: Single session of Motivational Interviewing
- Change in the number of drinks and frequency of drinks in the past two months [ Time Frame: Baseline, 2 months, 6 months, and 12 months ]Change in daily drinking patterns (quantity and frequency) over the past two months using the Timeline follow-back assessment
- Change in the severity of alcohol use within past 30 days [ Time Frame: Baseline, 2 months, 6 months, and 12 months ]Change in alcohol Addiction Severity Index (ASI) scores in the past 30 days
- Change in employment, psychiatric status, and legal status over the past 30 days [ Time Frame: Baseline, 2 months, 6 months, and 12 months ]Change in employment, psychiatric status, and legal status over the past 30 days as assessed by the Addiction Severity Index (ASI)
- Change in mental health [ Time Frame: Baseline, 2 months, 6 months, and 12 months ]Change in emotions, moods, thoughts, and behaviors in the past two weeks as assessed by the Psychiatric Diagnostic Screening Questionnaire (PDSQ)
- Change in trauma and stress levels [ Time Frame: Baseline, 2 months, 6 months, and 12 months ]Change in drinking consequences scores as assessed by Alcohol and Drug Consequences Questionnaire (ADCQ)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272023
|United States, California|
|New Leaf Treatment Center|
|Lafayette, California, United States, 94549|
|Principal Investigator:||Douglas Polcin, Ed.D.||Alcohol Research Group / Public Health Institute|