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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
Sponsor:
Information provided by (Responsible Party):
Public Health Institute, California

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1) Female 2)18 years or older 3) meets DSM-V criteria for current alcohol use disorder in the past 30 days, as assessed by the DSM-V Checklist, defined as 2 or more criterion 4) alcohol in the past 30 days and medically cleared by NLTC medical personnel 5) able to speak and read English, 6) capable of giving informed consent 7) likely to be in the area the next 12 months.

Exclusion Criteria:

  1. has had alcohol in the past 3 days and may require medical treatment for alcohol or drug detoxification and is not followed by a physician or has not been medically cleared by NLTC medical personnel
  2. or has unmet needs for treatment of serious medical or psychiatric conditions
  3. any condition that would impair their ability to provide informed consent
  4. current severe drug use disorder, defined as 6 or more DSM-V criteria in the past 30 days, 5.)Currently enrolled in alcohol or drug treatment

6) Does not meet DSM-V criteria for current alcohol use disorder as assessed by the DSM-V Checklist, 7) Refuses to sign HIPPA authorization form 8) Any medical or psychosocial condition that would preclude safe, useful, or consistent participation


Information from the National Library of Medicine

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


Locations
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United States, California
New Leaf Treatment Center
Lafayette, California, United States, 94549
Sponsors and Collaborators
Public Health Institute, California
Investigators
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Principal Investigator: Douglas Polcin, Ed.D. Alcohol Research Group / Public Health Institute

Additional Information:
Publications:

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Responsible Party: Public Health Institute, California
ClinicalTrials.gov Identifier: NCT02272023    
Other Study ID Numbers: R01AA022857 ( U.S. NIH Grant/Contract )
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Keywords provided by Public Health Institute, California:
alcohol
women
motivational interviewing
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders