Women's Treatment and Early Recovery

NCT02977988 | Completed Results

• 2 other identifiers: UP-14-00391-AM0015R01DA038648-04
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance-related Disorders

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

Outcome Measures

Primary Outcomes (2)

• Treatment Completion

  Number of women being designated by the site clinic as a completer during a discharge event.

  5 month follow period

• Days of Any Drug Use

  Days of any drug use to include multiple drug types from study intervention end date to follow-up

  8.5 months

Secondary Outcomes (1)

• Psychological Symptoms

  8.5 months

Study Arms (2)

Mindfulness Meditation

EXPERIMENTAL

Mindfulness-Based Relapse Prevention-Women (MBRP-W)

Behavioral: Mindfulness Meditation

Active Comparator

ACTIVE COMPARATOR

Brain and Recovery (B\&R)

Behavioral: Brain and Recovery (B&R)

Interventions

Mindfulness Meditation BEHAVIORAL

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.

Also known as: Mindfulness-Based Relapse Prevention-Women (MBRP-W)

Mindfulness Meditation

Brain and Recovery (B&R) BEHAVIORAL

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.

Active Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Southern California: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Prototypes' Pomona Women's Center

Pomona, California, 91767, United States

Location

Related Publications (16)

• Amaro H, Spear S, Vallejo Z, Conron K, Black DS. Feasibility, acceptability, and preliminary outcomes of a mindfulness-based relapse prevention intervention for culturally-diverse, low-income women in substance use disorder treatment. Subst Use Misuse. 2014 Apr;49(5):547-59. doi: 10.3109/10826084.2013.852587.

  PMID: 24611850 BACKGROUND

• Black DS, O'Reilly GA, Olmstead R, Breen EC, Irwin MR. Mindfulness-based intervention for prodromal sleep disturbances in older adults: design and methodology of a randomized controlled trial. Contemp Clin Trials. 2014 Sep;39(1):22-7. doi: 10.1016/j.cct.2014.06.013. Epub 2014 Jul 1.

  PMID: 24993561 BACKGROUND

• Hanley A, Garland EL, Black DS. Use of mindful reappraisal coping among meditation practitioners. J Clin Psychol. 2014 Mar;70(3):294-301. doi: 10.1002/jclp.22023. Epub 2013 Jul 1.

  PMID: 23818289 BACKGROUND

• Li MJ, Black DS, Garland EL. The Applied Mindfulness Process Scale (AMPS): A process measure for evaluating mindfulness-based interventions. Pers Individ Dif. 2016 Apr 1;93:6-15. doi: 10.1016/j.paid.2015.10.027.

  PMID: 26858469 BACKGROUND

• Black DS, Slavich GM. Mindfulness meditation and the immune system: a systematic review of randomized controlled trials. Ann N Y Acad Sci. 2016 Jun;1373(1):13-24. doi: 10.1111/nyas.12998. Epub 2016 Jan 21.

  PMID: 26799456 BACKGROUND

• Galla BM, O'Reilly GA, Kitil MJ, Smalley SL, Black DS. Community-Based Mindfulness Program for Disease Prevention and Health Promotion: Targeting Stress Reduction. Am J Health Promot. 2015 Sep-Oct;30(1):36-41. doi: 10.4278/ajhp.131107-QUAN-567. Epub 2014 Aug 27.

  PMID: 25162319 BACKGROUND

• Garland EL, Black DS. Mindfulness for chronic pain and prescription opioid misuse: novel mechanisms and unresolved issues. Subst Use Misuse. 2014 Apr;49(5):608-11. doi: 10.3109/10826084.2014.852801. No abstract available.

  PMID: 24611857 BACKGROUND

• Peltz L, Black DS. The thinking mind as addiction: mindfulness as antidote. Subst Use Misuse. 2014 Apr;49(5):605-7. doi: 10.3109/10826084.2014.852803. No abstract available.

  PMID: 24611856 BACKGROUND

• Witkiewitz K, Black DS. Unresolved issues in the application of mindfulness-based interventions for substance use disorders. Subst Use Misuse. 2014 Apr;49(5):601-4. doi: 10.3109/10826084.2014.852797. No abstract available.

  PMID: 24611855 BACKGROUND

• Black DS. Mindfulness-based interventions: an antidote to suffering in the context of substance use, misuse, and addiction. Subst Use Misuse. 2014 Apr;49(5):487-91. doi: 10.3109/10826084.2014.860749.

  PMID: 24611846 BACKGROUND

• Black DS. Mindfulness and substance use intervention. Subst Use Misuse. 2012 Feb;47(3):199-201. doi: 10.3109/10826084.2011.635461. No abstract available.

  PMID: 22217122 BACKGROUND

• Amaro H, Black DS. Mindfulness-Based Intervention Effects on Substance Use and Relapse Among Women in Residential Treatment: A Randomized Controlled Trial With 8.5-Month Follow-Up Period From the Moment-by-Moment in Women's Recovery Project. Psychosom Med. 2021 Jul-Aug 01;83(6):528-538. doi: 10.1097/PSY.0000000000000907.

  PMID: 34213858 BACKGROUND

• Amaro H, Black DS. Moment-by-Moment in Women's Recovery: Randomized controlled trial protocol to test the efficacy of a mindfulness-based intervention on treatment retention and relapse prevention among women in residential treatment for substance use disorder. Contemp Clin Trials. 2017 Nov;62:146-152. doi: 10.1016/j.cct.2017.09.004. Epub 2017 Sep 14.

  PMID: 28918120 RESULT

• Black DS, Amaro H. Moment-by-Moment in Women's Recovery (MMWR): Mindfulness-based intervention effects on residential substance use disorder treatment retention in a randomized controlled trial. Behav Res Ther. 2019 Sep;120:103437. doi: 10.1016/j.brat.2019.103437. Epub 2019 Jul 7.

  PMID: 31419610 RESULT

• Kechter A, Amaro H, Black DS. Reporting of Treatment Fidelity in Mindfulness-Based Intervention Trials: A Review and New Tool using NIH Behavior Change Consortium Guidelines. Mindfulness (N Y). 2019 Feb;10(2):215-233. doi: 10.1007/s12671-018-0974-4. Epub 2018 Jun 22.

  PMID: 30854147 RESULT

• Rivera D, Dueker D, Amaro H. Examination of referral source and retention among women in residential substance use disorder treatment: a prospective follow-up study. Subst Abuse Treat Prev Policy. 2021 Mar 2;16(1):21. doi: 10.1186/s13011-021-00357-y.

  PMID: 33653374 DERIVED

Related Links

• American Mindfulness Research Association

MeSH Terms

Conditions

Substance-Related Disorders; Behavior, Addictive

Interventions

Mindfulness; Salvage Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Therapeutics

Results Point of Contact

• Title: David Black
• Organization: University of Southern California

davidbla@usc.edu

8184260733

Study Officials

• David S Black, PhD, MPH

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Public Health Sciences

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: November 30, 2016
• Study Start: October 15, 2015
• Primary Completion: August 17, 2018
• Study Completion: June 30, 2019
• Last Updated: January 13, 2026
• Results First Posted: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data available from 2021 and for 5 years after contacting davidbla@usc.edu for shared files.
• Access Criteria: Contact davidbla@usc.edu

Locations

US (1)