Prototypes' Pomona Women's Center
Pomona, California, 91767, United States
NCT Number: NCT02977988
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.
Looking for future studies?
Notify Me18 year–65 year
Female
Interventional
Not applicable
Pomona, California, 91767, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for parent study:
Exclusion criteria
for parent study:
Additional exclusion criteria for brain imaging sub-study:
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.
Other names: Mindfulness-Based Relapse Prevention-Women (MBRP-W)
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.
Time frame: 5 month follow period
Number of women being designated by the site clinic as a completer during a discharge event.
Time frame: 8.5 months
Days of any drug use to include multiple drug types from study intervention end date to follow-up
Time frame: 8.5 months
Five Facet Mindfulness Questionnaire (FFMQ): higher scores indicate better mindfulness qualities (better outcome).
Perceived Stress Scale (PSS): higher scores indicate greater perceived stress (worse outcome).
Depression Anxiety Stress Scale (DASS): higher scores indicate greater depression, anxiety, and stress (worse outcome).
Distress Tolerance Scale (DTS): higher scores indicate greater distress tolerance (better outcome).
Difficulties in Emotion Regulation Scale (DERS): higher scores indicate greater difficulties in emotion regulation (worse outcome).
Penn Craving Scale (PCS): higher scores indicate greater craving (worse outcome).
Positive and Negative Affect Schedule (PANAS) - Negative Affect subscale: higher scores indicate greater negative affect (worse outcome).
Minimum and maximum values are not standardized.
University of Southern California
Other
Neural Mechanisms in Women's Treatment and Early Recovery
Acronym: MBRP-W
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05998005
Behavior, Behavior, Addictive
Bonners Ferry, Idaho, United States
View Trial DetailsNCT07590154
Addiction, Behavior
Ajijic, Jalisco, Mexico
View Trial DetailsNCT03606759
Addictive Behavior, Behavior
Bordeaux, France
View Trial DetailsNCT07395700
Behavior, Behavior, Addictive
Ajijic, Jalisco, Mexico
View Trial Details