N/A
N=200
Women's Treatment and Early Recovery
Substance-related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02977988 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Treatment Completion — 43; 31 Number of women — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness Meditation (Behavioral); Brain and Recovery (B&R) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Southern California
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Completion |
43; 31 | <0.05 sig |
| PRIMARY Days of Any Drug Use |
16.92; 24.97 | <0.05 sig |
| SECONDARY Psychological Symptoms |
83; 85; 18; 17; 9; 9 | <0.05 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02977988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.