Randomized Trial of Intensive Motivational Interviewing (IMI) to Improve Drinking Outcomes Among Women

NCT02272023 | Completed

• 1 other identifier: R01AA022857
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorders

Keywords

alcohol; women; motivational interviewing

Outcome Measures

Primary Outcomes (2)

• Change in the number of drinks and frequency of drinks in the past two months

  Change in daily drinking patterns (quantity and frequency) over the past two months using the Timeline follow-back assessment

  Baseline, 2 months, 6 months, and 12 months

• Change in the severity of alcohol use within past 30 days

  Change in alcohol Addiction Severity Index (ASI) scores in the past 30 days

  Baseline, 2 months, 6 months, and 12 months

Secondary Outcomes (3)

• Change in employment, psychiatric status, and legal status over the past 30 days

  Baseline, 2 months, 6 months, and 12 months

• Change in mental health

  Baseline, 2 months, 6 months, and 12 months

• Change in trauma and stress levels

  Baseline, 2 months, 6 months, and 12 months

Study Arms (2)

9 sessions of Intensive Motivational Interviewing

EXPERIMENTAL

Experimental condition will consist of 9 1-hour intensive motivational interviewing sessions.

Behavioral: Intensive Motivational Interviewing

1 Standard Motivational Interview plus 8 nutrition classes

ACTIVE COMPARATOR

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

Interventions

Intensive Motivational Interviewing BEHAVIORAL

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.

9 sessions of Intensive Motivational Interviewing

Single session of Motivational Interviewing BEHAVIORAL

1 Standard Motivational Interview plus 8 nutrition classes

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• 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
• or has unmet needs for treatment of serious medical or psychiatric conditions
• any condition that would impair their ability to provide informed consent
• 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
• \) 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

Sponsors & Collaborators

• Public Health Institute, California: lead

Study Sites (1)

New Leaf Treatment Center

Lafayette, California, 94549, United States

Location

Related Publications (13)

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  PMID: 14516234 BACKGROUND

• Carroll KM, Ball SA, Nich C, Martino S, Frankforter TL, Farentinos C, Kunkel LE, Mikulich-Gilbertson SK, Morgenstern J, Obert JL, Polcin D, Snead N, Woody GE; National Institute on Drug Abuse Clinical Trials Network. Motivational interviewing to improve treatment engagement and outcome in individuals seeking treatment for substance abuse: a multisite effectiveness study. Drug Alcohol Depend. 2006 Feb 28;81(3):301-12. doi: 10.1016/j.drugalcdep.2005.08.002. Epub 2005 Sep 28.

  PMID: 16169159 BACKGROUND

• Downey L, Rosengren DB, Donovan DM. Sources of motivation for abstinence: a replication analysis of the reasons for quitting questionnaire. Addict Behav. 2001 Jan-Feb;26(1):79-89. doi: 10.1016/s0306-4603(00)00090-3.

  PMID: 11196294 BACKGROUND

• Dunn C, Deroo L, Rivara FP. The use of brief interventions adapted from motivational interviewing across behavioral domains: a systematic review. Addiction. 2001 Dec;96(12):1725-42. doi: 10.1046/j.1360-0443.2001.961217253.x.

  PMID: 11784466 BACKGROUND

• Hettema J, Steele J, Miller WR. Motivational interviewing. Annu Rev Clin Psychol. 2005;1:91-111. doi: 10.1146/annurev.clinpsy.1.102803.143833.

  PMID: 17716083 BACKGROUND

• Miller WR, Yahne CE, Tonigan JS. Motivational interviewing in drug abuse services: a randomized trial. J Consult Clin Psychol. 2003 Aug;71(4):754-63. doi: 10.1037/0022-006x.71.4.754.

  PMID: 12924680 BACKGROUND

• Mullins SM, Suarez M, Ondersma SJ, Page MC. The impact of motivational interviewing on substance abuse treatment retention: a randomized control trial of women involved with child welfare. J Subst Abuse Treat. 2004 Jul;27(1):51-8. doi: 10.1016/j.jsat.2004.03.010.

  PMID: 15223094 BACKGROUND

• Matching Alcoholism Treatments to Client Heterogeneity: Project MATCH posttreatment drinking outcomes. J Stud Alcohol. 1997 Jan;58(1):7-29.

  PMID: 8979210 BACKGROUND

• Matching alcoholism treatments to client heterogeneity: Project MATCH three-year drinking outcomes. Alcohol Clin Exp Res. 1998 Sep;22(6):1300-11. doi: 10.1111/j.1530-0277.1998.tb03912.x.

  PMID: 9756046 BACKGROUND

• Schneider RJ, Casey J, Kohn R. Motivational versus confrontational interviewing: a comparison of substance abuse assessment practices at employee assistance programs. J Behav Health Serv Res. 2000 Feb;27(1):60-74. doi: 10.1007/BF02287804.

  PMID: 10695241 BACKGROUND

• Sellman JD, Sullivan PF, Dore GM, Adamson SJ, MacEwan I. A randomized controlled trial of motivational enhancement therapy (MET) for mild to moderate alcohol dependence. J Stud Alcohol. 2001 May;62(3):389-96. doi: 10.15288/jsa.2001.62.389.

  PMID: 11414349 BACKGROUND

• Winhusen T, Kropp F, Babcock D, Hague D, Erickson SJ, Renz C, Rau L, Lewis D, Leimberger J, Somoza E. Motivational enhancement therapy to improve treatment utilization and outcome in pregnant substance users. J Subst Abuse Treat. 2008 Sep;35(2):161-73. doi: 10.1016/j.jsat.2007.09.006. Epub 2008 Feb 20.

  PMID: 18083322 BACKGROUND

• Miller WR. What really drives change? Addiction. 1993 Nov;88(11):1479-80. doi: 10.1111/j.1360-0443.1993.tb03133.x. No abstract available.

  PMID: 8286993 BACKGROUND

Related Links

• website

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Douglas Polcin, Ed.D.

  Alcohol Research Group / Public Health Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 22, 2014
• Study Start: February 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 7, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Locations

US (1)