Women's Treatment and Early Recovery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neural Mechanisms in Women's Treatment and Early Recovery

Conditions
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Substance-related Disorders

Intervention / Treatment
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* Behavioral: Mindfulness Meditation
* Behavioral: Brain and Recovery (B&R)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for parent study: Female Adult in California (18 years or older) Diagnosed with a substance use disorder (SUD) Speaks fluent English Client at study site, substance use disorder residential facility at time of recruitment Exclusion criteria for parent study: Inability to comprehend informed consent Unwilling to sign informed consent Cognitive impairment, psychotic disorder or severe chronic mental health condition based on clinical intake DSM-V assessment Older than 65 years of age Reported suicidality in last 30 days Current prisoner Pregnant in the 3rd trimester Pregnant (MRI subsample only) Not willing to be audio recorded Not willing to have data stored for research purposes Additional exclusion criteria for brain imaging sub-study: Older than 50 years of age Not in good general health Left handed (with a mean item score >1 on the handedness scale) Currently pregnant Current medical devices (cardiac pacemaker, implanted cardiac defibrillator, carotid artery vascular clamp, neurostimulator, cochlear implant, metal fragments (including shrapnel) in the head, eyes, or skin, vascular stent, ocular implant, penile implant, vascular filter for clots (including Greenfield, Umbrella, or Birds Nest filters) Other non-removable devices (IUD, dental braces or retainer, piercings that cannot be removed prior to resting, permanent eye-liner) Body Mass Index (BMI) greater than 36 History of head trauma resulting in loss of consciousness for more than 5 minutes Documented or subjectively reported claustrophobia Having hair extensions or a wig connected by wire

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness Meditation<br>Mindfulness-Based Relapse Prevention-Women (MBRP-W) | Behavioral: Mindfulness Meditation<br>* 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.<br>* Other names: Mindfulness-Based Relapse Prevention-Women (MBRP-W);|
| Active Comparator: Active Comparator<br>Brain and Recovery (B&R) | Behavioral: Brain and Recovery (B&R)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days in residential treatment | Days in residential treatment confirmed by residential clinic archival records | 11 month interval | 
| Use of and relapse to alcohol and illicit drugs | Use of and relapse to alcohol and illicit drug obtained from the interviewer-assisted timeline followback calendar and confirmed by urine drug screen and alcohol breathalyzer test | 11 month interval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural correlates | Brain tissue morphology and neural network correlates of mindfulness training obtained from magnetic resonance imaging (MRI) and functional magnetic resonance imaging (fMRI) in subsample of n=15 in each treatment group at pre- and immediate post-intervention. | 10 week interval | 
| Psychological mechanisms of action underlying intervention | Self-report of mindfulness qualities, perceived stress, psychological distress, distress tolerance, self-regulation, craving, and negative affect | 11 month interval | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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