Alcohol, Inflammation, and Mindfulness Study (AIM)
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      The goal of the AIM Study is to examine the effectiveness of Mindfulness Based Relapse
      Prevention (MBRP) versus Relapse Prevention (RP) for the treatment of Alcohol Use Disorders
      (AUD) by implementing an 8-week long intervention and examining neurobiological,
      immunological, and epigenetic characteristics of AUD.
    

Detailed description: 
      This study was designed to evaluate the effect of two outpatient, individually-administered,
      psychosocial interventions (Relapse Prevention vs. Mindfulness-Based Relapse Prevention).
      Participants are recruited via mass media advertisements, flyers, and local outreach to
      clinical providers that do not address substance use. We will recruit 226 individuals. Our
      previous experience with clinical trials, as well as the experience of our research team
      members with these interventions support the feasibility of recruiting approximately 50
      patients per year. This sample size provides adequate statistical power for the research
      questions undertaken.

      Participants are screened over the telephone and invited into the laboratory for a baseline
      assessment. Immediately after the baseline assessment, they are randomized to a therapist and
      then to a treatment condition. At the end of each year, the distribution of participants
      across conditions and therapists are evaluated for imbalances. If attrition has resulted in
      an imbalance across conditions, the randomization procedure will be adjusted to ensure equal
      numbers of participants in RP and MBRP.

      Within a week of completing the baseline assessments, participants are seen by their
      individual therapist for a motivational interviewing, goal-setting session. After the
      goal-setting session, the eight-session MBRP or RP treatments are administered. To ensure
      that therapists adhere to treatment manuals, a checklist is provided consisting of the
      primary content addressed each session (four to seven primary content pieces each session).
      Further, questionnaires assessing mindfulness practice and facets of mindfulness (e.g., being
      nonjudgmental, nonreactive) are administered at each assessment. At the most recent RPPR,
      these questionnaires validated that participants in the MBRP condition were increasing in
      some facets of mindfulness during treatment (and up to three months after treatment).

      We estimate that the completion of assessments and procedures across the duration of the
      trial, excluding therapy sessions, will total about 15 hours of time. To compensate subjects
      for their time and travel costs, each subject will be paid $300 if they complete all
      sessions.

      We will conduct extensive analyses of any attrition encountered in the project to determine
      bias. However, note that in each of the analyses described herein, we will have the
      capability of using modern approaches to the handling of missing data including full
      information maximum likelihood estimation of missing data within Proc Mixed in SAS and within
      EQS.

      The distributional properties of all continuously scaled variables will be examined for
      skewness and kurtosis to determine the need for normalizing transformations or for
      alternations to our analysis plan (i.e., generalized estimating equations or robust
      estimation) prior to the primary analyses.

      To confirm the validity of random assignment, pretest equivalence of the two treatment
      conditions across demographics, drinking history, smoking, and all other baseline measures
      will be assessed via t-tests on continuous items and c2 tests of categorical items. We will
      use the Bonferroni approach to correct for alpha inflation with a familywise alpha of .05.
      Any variables on which the two groups are unequal at pretest will be covariates in all
      further analyses.

      Attrition analyses will be conducted after each follow-up data collection effort to provide
      assurance that differential attrition by treatment condition has not occurred. Following
      previously published procedures, a series of ANOVAs of treatment (MBRP versus RP) X retention
      (retained, not retained) will be conducted on continuous baseline measures. Significant
      treatment X retention interactions identify measured variables on which differential
      attrition may have occurred. The logit model analog procedure will be applied to categorical
      baseline measures to test for differential attrition on categorical variables such as gender
      and ethnicity. We will conduct these analyses to assure that differential attrition by
      treatment condition does not account for any of the effects of the treatments.
    

Intervention name(s): Mindfulness-Based Relapse Prevention Therapy; Relapse Prevention Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.; An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment