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

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

Interventions

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.

BEHAVIORAL

Single session of Motivational Interviewing

Sponsors & Collaborators

• Public Health Institute, California

  lead OTHER

Principal Investigators

• Douglas Polcin, Ed.D. · Alcohol Research Group / Public Health Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-02-28

Primary Completion

2019-03-31

Completion

2019-03-07

Countries

• United States

Study Locations