Women's Treatment and Early Recovery
Condition: Substance-related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Approximately 25 million Americans struggle with alcohol or drug problems annually. Abuse of
      alcohol and drugs is costly to our nation, exacting more than $428 billion in costs related
      to crime, lost work productivity and health care. While effective treatments exist, over half
      of those who enter treatment for substance use disorders drop out early in treatment and
      return to alcohol or drug abuse. Psychological stress is a causal factor in the pathogenesis
      of substance use disorder (SUD) and relapse risk. Low-income women report high levels of
      stress in SUD residential treatment stemming from significant economic and family stressors
      in addition to challenges of adjusting to residential treatment demands. Unmanaged stress,
      especially in early stages of residential treatment, is a major concern because it can
      increase dropout. Dropout from residential treatment places women at risk of substance use
      relapse. A gap in knowledge persists regarding the use of mindfulness-based interventions
      with racially/ethnically diverse low-income women with SUDs, especially regarding the
      efficacy of adapted (Mindfulness-based interventions) MBIs for preventing residential dropout
      and decreasing relapse. We have fully adapted, developed, and pilot tested a novel MBI,
      Moment-by-Moment in Women's Recovery: Mindfulness Based Relapse Prevention for Women
      (MBRP-W), that supports the needs of women in residential treatment. This MBI integrates
      relapse prevention, addresses literacy level, and is relevant to issues surrounding
      treatment- and relapse-related stressors of disadvantaged women. The current project has
      three specific aims: (1) to test the efficacy of MBRP-W on residential treatment retention
      and substance use relapse in racially/ethnically diverse low-income women; (2) to determine
      the mechanisms of change underlying the MBRP-W program; and (3) to explore neural changes
      associated with program effects. A rationale for MBRP-W is the need for self-initiated stress
      management skills in women with SUDs during the early stressful periods of residential
      treatment that increase risk of dropout and relapse.
    

Detailed description: 
      -  This randomized clinical trial will deliver two interventions as add-ons to residential
           substance use disorder (SUD) treatment: (1) Moment-by-Moment in women's Recovery:
           Mindfulness-Based Approach to Relapse Prevention (MBRP-W) and (2) Brain and Recovery
           (B&R) which serves as an active psychoeducational attention control group.

        -  Participants (N=165) who meet study eligibility criteria based on intake assessment will
           be recruited and complete baseline assessments during weeks 3-6 after entry into a
           residential treatment program. Participants will be randomly assigned to interventions
           using Urn randomization. All participants (MBRP-W and B&R) will receive SUD treatment as
           normally provided by the treatment program. Fifteen participants from each intervention
           group (N=30) will be selected to participate in a brain imaging (MRI and fMRI) substudy.

        -  Participants will be adult females who have been admitted to a residential treatment
           center in an urban area of California and who are diagnosed with a SUD based on clinical
           intake Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V)
           diagnostic assessment.

        -  MBRP-W is delivered in 12 bi-weekly 80-minute group sessions with SUD clinical
           populations. Facilitators will have previous experience in MBSR facilitation and will be
           trained in MBRP-W. Each session has a central theme and is divided into five segments
           consisting of (a) a welcome meditation or other mindfulness practice, (b) a review of
           session objectives, (c) a brief didactic psycho-educational presentation and discussion
           based on the session's theme, (d) experiential and formal meditation or other practices,
           and (e) readings and practice assignments for the next class.

        -  B&R is delivered in 12 bi-weekly 80-minute group sessions with SUD clinical populations.
           Facilitators will be trained in B&R. The B&R group will receive didactic education on
           the neurobiology of addiction. B&R contains no information on behavior change, relapse
           prevention, stress reduction, or mindfulness-based or relapse-related content. The
           intervention was developed over three years with a population similar to that of the
           current study (i.e., racially/ethnically diverse and low-income women in SUD treatment)
           with input and review from focus group participants, care providers in SUD treatment,
           and three experts on the neurobiology of addiction. Topics include: (1) brain structure
           and function related to addiction, (2) effects of various types of substance use on the
           brain, and (3) rewarding effects of substance use and how these rewarding effects can
           lead to addiction.

        -  There are three data collection points, 1) baseline, 2) immediate post-intervention, and
           3) 8-months post-intervention completion. Data will be collected in-person by research
           interviewers via computer-assisted interviews, which includes administration of an
           alcohol Breathalyzer test to assess alcohol use and collection of a urine sample to
           assess drug use. Interviews will be conducted at the treatment program (for those who
           remain in residential treatment) or at convenient locations for participants no longer
           in treatment. Baseline interview will occur prior to randomization, post-intervention
           interview will occur within 1-2 weeks of the last group session, and the follow-up
           interview will occur at an 8-months post-intervention completion window. Brain imaging
           for a subsample of participants will be completed at baseline and immediate
           post-intervention.

        -  Number of intervention program class sessions attended will be collected for all
           enrolled participants.

        -  Participant Satisfaction Surveys measuring acceptability, credibility, and perceived
           utility of the study arms will be administered to both groups at two class sessions.

        -  Applied Mindfulness Practice Scale (AMPS) measuring the participant's application of
           mindfulness skills to address life challenges, will be administered to the MBRP-W
           participants at four class sessions as well as at follow-up. Mindfulness practice effort
           will also be assessed at these same four class sessions.

        -  An in-treatment clinical record review of services will be collected weekly for the
           duration of residential treatment.
    

Intervention name(s): Mindfulness Meditation; Brain and Recovery (B&R)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): MBRP-W is delivered in 12 bi-weekly 80-minute group sessions. Facilitators with previous experience in MBSR and trained in MBRP-W will deliver each group. Each session has a central theme and is divided into five segments consisting of: (a) a welcome meditation or other mindfulness practice, (b) a review of session objectives, (c) a brief didactic psycho-educational presentation and discussion based on the session's theme, (d) experiential and formal meditation or other practices, and (e) readings and assignments for the next class. Participants are expected to learn skill building techniques to reducing stress using mindfulness-based principles to complement their recovery treatment program.; B&R is delivered in 12 bi-weekly 80-minute group sessions delivered by two trained interventionists. The B&R group will receive didactic education on the neurobiology of addiction. B&R contains no information on behavior change, stress reduction, or mindfulness-based or relapse-related content. The intervention was developed over three years with a population similar to those in the study and with input from patients and experts on neurobiology of addiction. Topics include: (1) brain structures and functions related to addiction, (2) effects of various types of substances on the brain, and (3) rewarding effects and how these lead to addiction. Participants are expected to gain knowledge pertaining to the effects of drugs on the brain.
Other intervention name(s): Mindfulness-Based Relapse Prevention-Women (MBRP-W)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mindfulness; Women; Relapse prevention; Clinical trial; Substance use disorder; Ethnically diverse; Underserved; Health disparities; Stress; Addiction; Latina/Hispanic; African American; Treatment retention; Residential treatment; Brain Imaging