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

The proposed study responds to the Program Announcement PA-10-100, "Alcohol Use Disorders:
Treatment, Services Research, and Recovery" (R01) issued by the National Institute on Alcohol
Abuse and Alcoholism (NIAAA). Our application addresses the priorities of this announcement
by proposing a phase II randomized clinical trial comparing intensive motivational
interviewing (IMI) to standard motivational interviewing techniques (SMI) for alcohol
dependent women. The study will use mixed model quantitative and qualitative methods to
respond to the program announcement'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.

SMI was initially developed as a brief intervention (typically 1-3 sessions) for the
treatment of problem drinkers (Miller & Rollnick, 2002). The general strategy of SMI is to
strategically combine supportive and directive interventions as a way to elicit ambivalence
about substance use (i.e., pros and cons) and thereby increase motivation for change.
Systematic reviews of the alcohol treatment literature have consistently shown SMI to be
effective for treating alcohol use disorders (Hettema, Steele, & Miller, 2005; Dunn, Deroo,
Rivera, 2001). Studies have shown SMI to be effective as a stand-alone treatment for alcohol
problems (Project MATCH Research Group, 1997; Miller, 1993; Sellman, Sullivan, Dore, Adamson,
& MacEwan, 2001) and as preparation for more intensive treatment (Burke, Arkowitz, &
Menchola, 2003). Perhaps the best-known and largest study of an SMI based was an assessment
of "motivational enhancement therapy" (MET) as a stand-alone, 4 session condition conducted
by the Project MATCH Research Group (Sellman, Sullivan, Dore, Adamson, & MacEwan, 2001;
Project MATCH Research Group, 1998). Participants were randomly assigned to 4 sessions of
MET, 12 sessions of cognitive behavioral counseling (CBT), or 12 sessions of 12-step
facilitation (TSF). Despite fewer sessions in MET, outcomes among the 3 conditions were
comparable. A limitation of the study was that individuals with serious co-occurring drug or
mental health problems were excluded as were those with housing instability.

Like Project MATCH, most studies of SMI for alcohol problems have excluded participants who
have serious co-occurring drug and mental health problems. However, these are precisely the
types of individuals that treatment practitioners are likely to encounter in publicly funded
treatment programs. When SMI interventions have targeted illicit drug dependence the results
have been mixed. While a number of reviews (Dunn, Deroo, Rivera, 2001) and meta-analyses
(Burke, Arkowitz, & Menchola, 2003; Hettema, Steele, & Miller, 2005) have concluded standard
low-dose SMI is effective as preparation for more intensive drug treatment, some studies
contradict these findings (Downey, Rosengren, & Donovan, 2001; Miller, Yahne, Tonigan, 2003;
Winhusen et al., 2008; Mullins, Suerez, Ondersman, Page, 2004; Schneider, Casey, Kohn, 2000).
When effects have been found for drug and co-occurring disorders they have most commonly been
for retention, not substance use (Carroll et al., 2006).

Procedures for the proposed study draw from our current successful RCT assessing IMI for 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. Two hundred
and twenty alcohol dependent women will be randomly assigned to IMI or SMI with an attention
component for time equivalence (nutrition education). Participants in both groups will
receive standard group treatment offered at the program. 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.

Aim 1: To compare drinking and alcohol problems among women receiving IMI and SMI.

Hypothesis 1.1: During the active phase of treatment (weeks 1-9) women in IMI will have fewer
positive breathalyzer screens, drinking days, and heavy drinking days (4+ drinks) than women
in SMI.

Hypothesis 1.2: Women in IMI will demonstrate fewer drinking days and heavy drinking days (4+
drinks) and lower scores on the Addiction Severity Index (ASI) Alcohol Scale at 2, 6, and 12
months.

Aim 2: To assess potential mediators of drinking and alcohol problems. Hypothesis 2.1:
Measures of retention, therapeutic alliance, social support, and motivation will mediate the
relationship between study condition and drinking outcome.

Aim 3: To Use qualitative interviews to identify additional factors that influence outcome.
Content areas will include perceptions of the therapist, IMI & SMI interventions, the CBT
group, and external influences such as Alcoholics Anonymous (AA), intimate partners, friends,
and family.

Exploratory Aims: 1) To compare IMI and SMI outcomes on ASI scales, psychiatric symptoms, AA
involvement, and trauma symptoms.

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