Substance-related Disorders Clinical Trial
— MBRP-WOfficial title:
Neural Mechanisms in Women's Treatment and Early Recovery
Verified date | October 2019 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | June 30, 2019 |
Est. primary completion date | August 17, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Prototypes' Pomona Women's Center | Pomona | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | National Institute on Drug Abuse (NIDA) |
United States,
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 dis — View Citation
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. — View Citation
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.201 — View Citation
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. — View Citation
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. Review. — View Citation
Black DS. Mindfulness and substance use intervention. Subst Use Misuse. 2012 Feb;47(3):199-201. doi: 10.3109/10826084.2011.635461. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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 — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Days in residential treatment | Days in residential treatment confirmed by residential clinic archival records | 11 month interval | |
Primary | 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 | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05054738 -
CRP and S&A for Inpatient Veterans
|
N/A | |
Recruiting |
NCT04157062 -
An Open-Label Trial of Repetitive Transcranial Magnetic Stimulation for Opioid Use Disorder
|
N/A | |
Completed |
NCT02233738 -
Group Motivational Interviewing (GMI) For Homeless Veterans In VA Services
|
N/A | |
Enrolling by invitation |
NCT06084221 -
Fatal Overdose Review Teams - Research to Enhance Surveillance Systems
|
N/A | |
Completed |
NCT02907944 -
Working With HIV Clinics to Adopt Addiction Treatments Using Implementation Facilitation
|
N/A | |
Completed |
NCT02829970 -
Helping College Students With ADHD Lead Healthier Lifestyles
|
N/A | |
Completed |
NCT02570360 -
Exercise and Treatment-as-usual in Substance Use Treatment Outcomes
|
N/A | |
Completed |
NCT02715557 -
Arise: An Online Relapse Prevention Tool for Adolescent Substance Abusers
|
N/A | |
Completed |
NCT02125539 -
Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment
|
Phase 2 | |
Completed |
NCT02945371 -
Tailored Inhibitory Control Training to Reverse EA-linked Deficits in Mid-life
|
N/A | |
Completed |
NCT02388243 -
The Computer-based Drug and Alcohol Training Assessment in Kenya
|
N/A | |
Completed |
NCT02218970 -
The Effect of Muscular Strength Training in Patients With Drug Addiction
|
N/A | |
Completed |
NCT01633138 -
Performance-based Reinforcement to Enhance Cognitive Remediation Therapy
|
N/A | |
Completed |
NCT01591239 -
Home-Based Program to Help Parents of Drug Abusing Adolescents
|
N/A | |
Active, not recruiting |
NCT01539525 -
Screening to Augment Referral to Treatment- Project START
|
Phase 2 | |
Withdrawn |
NCT01224002 -
A Comparative Feasibility Study to Assess the Prevalence and Severity of Dental Caries in Incarcerated People Who Abuse Methamphetamine
|
N/A | |
Withdrawn |
NCT00891631 -
Primary Care iSBIRT to Reduce Serious Teen Health Risks
|
Phase 1/Phase 2 | |
Completed |
NCT01365247 -
Concurrent Treatment for Substance Dependent Individuals With Post-Traumatic Stress Disorder (PTSD)
|
N/A | |
Completed |
NCT00970372 -
Dual-Diagnosis and Compulsory Treatment
|
N/A | |
Completed |
NCT00419029 -
Motivational Interviewing to Engage Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) Veterans in Mental Health Treatment
|
N/A |