- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07417579
Mindfulness and Meditation-Based Relapse Prevention for Substance Use Disorders (MBRP-SUD)
Observational Case Series of Mindfulness- and Meditation-Based Relapse Prevention for Substance Use Disorders (MBRP-SUD)
Mindfulness and meditation based relapse prevention has been proposed as an adjunctive approach for individuals with substance use disorders (SUDs). This completed pilot observational case series describes outcomes from three de-identified participants who completed an eight-week mindfulness and meditation program designed to reduce stress, enhance coping skills, and support sustained recovery.
Participants demonstrated improvements in perceived stress and mindfulness following the intervention. Two participants experienced relapse within 10-12 months, while one participant maintained long-term sobriety. This small case series provides descriptive clinical insights and supports the feasibility of mindfulness-based interventions in real-world treatment settings.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This pilot observational case series evaluated an eight-week mindfulness and meditation-based relapse prevention program delivered to three de-identified adults with substance use disorders. The intervention included weekly guided mindfulness sessions, daily home practice, and group discussions focused on awareness of cravings, emotional regulation, and relapse prevention strategies.
Outcomes were assessed using self-reported perceived stress and mindfulness measures, along with qualitative clinical interviews and participant journals to monitor relapse behavior. All participants demonstrated improvements in perceived stress and mindfulness. Relapse occurred in two participants within one year, while one participant maintained long-term sobriety.
This study was exploratory and descriptive in nature, with a small sample size. Ethics review was not required as all participants were de-identified and the study was conducted as a clinical case series. Findings are intended to inform future research and larger-scale studies of mindfulness-based relapse prevention interventions.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Florida
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Boca Raton, Florida, United States, 33496
- Bout Me Healing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 years or older
- History of substance use disorder (any substance)
- Enrolled in or referred to an eight-week mindfulness and meditation-based relapse prevention program
- Willing and able to participate in weekly guided sessions, daily home practice, and group discussions
- Able to provide self-reported information on stress, mindfulness, and relapse experiences
Exclusion Criteria:
- Individuals under 18 years of age
- Inability or unwillingness to participate in mindfulness or meditation exercises
- Severe cognitive impairment or psychiatric condition preventing participation in group or home practice
- Participation in concurrent structured relapse prevention programs outside of this study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Mindfulness-Based Relapse Prevention Case Series
This cohort includes three adult participants with histories of substance use disorders who completed an eight-week mindfulness and meditation-based relapse prevention program delivered as part of routine clinical practice.
Participants engaged in guided mindfulness meditation sessions, daily home practice, and group discussions focused on stress awareness, emotional regulation, craving management, and relapse prevention skills.
Outcomes were assessed descriptively using self-reported stress and mindfulness measures, participant journals, and clinical interviews.
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The mindfulness and meditation-based relapse prevention program consisted of an eight-week structured intervention delivered as part of routine clinical practice.
Participants engaged in weekly guided mindfulness meditation sessions, daily individual home practice, and facilitated group discussions.
The intervention focused on developing awareness of thoughts, emotions, cravings, and stress responses, with an emphasis on nonjudgmental observation and emotional regulation.
Sessions included mindfulness exercises, breathing techniques, body awareness practices, and reflective discussion related to relapse prevention and coping strategies.
The program was not designed as a randomized or controlled intervention and was implemented uniformly across participants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Perceived Stress and Mindfulness Following Mindfulness-Based Relapse Prevention Program
Time Frame: Baseline (pre-intervention) to end of the eight-week program
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The primary outcome is the change in perceived stress and mindfulness levels in participants completing an eight-week mindfulness and meditation-based relapse prevention program.
Stress was assessed using the Perceived Stress Scale and mindfulness using the Five Facet Mindfulness Questionnaire.
Observations were collected through participant journals and clinical interviews, comparing baseline to post-intervention outcomes.
This outcome reflects the feasibility and potential impact of mindfulness-based practices in supporting emotional regulation and coping strategies for individuals with substance use disorders.
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Baseline (pre-intervention) to end of the eight-week program
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cice Rivera, MS, CAP, Bout Me Healing
Publications and helpful links
General Publications
- Rivera, Cice (2026). Mindfulness and Meditation-Based Relapse Prevention for Substance Use Disorders: Research Case Series of Three Participants. figshare. Journal contribution. https://doi.org/10.6084/m9.figshare.31302370.v1
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMH-MBRP-OBS-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Study Data/Documents
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Study Protocol
Information comments: https://bout-me-healing.com/ipdsharingplan/
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Clinical Study Report
Information identifier: MMRP_SUD_IPD_2025Information comments: Qualified researchers may request access to de-identified participant data, the study protocol, and the clinical study report. Requests will be reviewed and granted to support replication, meta-analyses, or related research. Data will be available for 3 years following publication. Requests should be submitted via the corresponding author's contact page or designated website. No identifying information will be shared, ensuring full confidentiality for participants.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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