Women's Treatment and Early Recovery

2016-12-01 16:08:22 | BioPortfolio


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.


- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Substance-related Disorders


Mindfulness Meditation, Brain and Recovery (B&R)


Prototypes' Pomona Women's Center
United States




University of Southern California

Results (where available)

View Results


Published on BioPortfolio: 2016-12-01T16:08:22-0500

Clinical Trials [2606 Associated Clinical Trials listed on BioPortfolio]

Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD

The current study will modify an already existing therapy for individuals with substance use disorders to address Post Traumatic Stress Disorder (PTSD) in women enrolled in substance use d...

Mindfulness Meditation as a Rehabilitation Strategy for Persons With Schizophrenia

The purpose of this study is to develop a treatment manual for mindfulness meditation to be taught in a group format to individuals with schizophrenia who are engaged in vocational rehabil...

Can Alternative Treatment Have an Impact on Cervical Dysplasia?

In this study two questions will be answered: - can mindfulness meditation help cell-changed on the cervix to disappear? - can mindfulness meditation lower the psychological distre...

Functional Magnetic Resonance Imaging (MRI) of Hypnosis and Mindfulness Meditation

Hypnotic trance and mindfulness meditation have both been shown to have benefits for physical health. The current study seeks to determine if there are distinct patterns of brain activity ...

Mindfulness Meditation Utilizing an EEG Biofeedback Device for the Treatment for Obsessive Compulsive Disorder

The Frederick W. Thompson Anxiety Disorders Centre has experienced significant demand for services related to the treatment of Obsessive Compulsive Disorder (OCD), resulting in a significa...

PubMed Articles [21860 Associated PubMed Articles listed on BioPortfolio]

Does mindfulness meditation improve chronic pain? A systematic review.

Psychological factors are associated with chronic pain. Mindfulness meditation may ameliorate symptoms. The objective was to evaluate the effects of mindfulness meditation in chronic pain.

Exploring relations among mindfulness facets and various meditation practices: Do they work in different ways?

Several meditation practices are associated with mindfulness-based interventions but little is known about their specific effects on the development of different mindfulness facets. This study aimed t...

Mindfulness and meditation as an adjunctive treatment for adolescents involved in the juvenile justice system: Is repairing the brain and nervous system possible?

Adolescents involved in the juvenile justice system are prone to more traumatic events than other adolescents, leaving them in danger of developmental difficulties. Trauma exposure is predictive of po...

Mind the Hype: A Critical Evaluation and Prescriptive Agenda for Research on Mindfulness and Meditation.

During the past two decades, mindfulness meditation has gone from being a fringe topic of scientific investigation to being an occasional replacement for psychotherapy, tool of corporate well-being, w...

Practising mindfulness.

What was the nature of the CPD activity, practice-related feedback and/or event and/or experience in your practice? The article examined the use of mindfulness techniques and how by learning to care f...

Medical and Biotech [MESH] Definitions

Disorders related to substance abuse, the side effects of a medication, toxin exposure, and ALCOHOL-RELATED DISORDERS.

These disorders are related to both SCHIZOPHRENIA SPECTRUM AND RELATED DISORDERS and DEPRESSIVE DISORDERS in terms of symptomatology, family history, and genetics. (DSM-V) .

A state of consciousness in which the individual eliminates environmental stimuli from awareness so that the mind can focus on a single thing, producing a state of relaxation and relief from stress. A wide variety of techniques are used to clear the mind of stressful outside interferences. It includes meditation therapy. (Mosby's Medical, Nursing, and Allied Health Dictionary, 4th ed)

A condition characterized by long-standing brain dysfunction or damage, usually of three months duration or longer. Potential etiologies include BRAIN INFARCTION; certain NEURODEGENERATIVE DISORDERS; CRANIOCEREBRAL TRAUMA; ANOXIA, BRAIN; ENCEPHALITIS; certain NEUROTOXICITY SYNDROMES; metabolic disorders (see BRAIN DISEASES, METABOLIC); and other conditions.

A psychological state of awareness, the practices that promote this awareness, a mode of processing information and a character trait. As a therapy mindfulness is defined as a moment-to-moment awareness of one's experience without judgment and as a state and not a trait.

More From BioPortfolio on "Women's Treatment and Early Recovery"

Quick Search

Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Stress is caused by your perception of situations around you and then the reaction of your body to them. The automatic stress response to unexpected events is known as 'fight or flight'. Discovered by Walter Cannon in 1932, it is the release of h...

Searches Linking to this Trial