NCT07417579

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2016

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 11, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

mindfulnessmeditationrelapse preventionsubstance usebehavioral healthaddiction recovery

Outcome Measures

Primary Outcomes (1)

  • Change in Perceived Stress and Mindfulness Following Mindfulness-Based Relapse Prevention Program

    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.

    Baseline (pre-intervention) to end of the eight-week program

Study Arms (1)

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.

Behavioral: Mindfulness and Meditation-Based Relapse Prevention Program

Interventions

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.

Mindfulness-Based Relapse Prevention Case Series

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of three de-identified adults with a history of substance use disorders who participated in an eight-week mindfulness and meditation based relapse prevention program. Participants included two females and one male, ranging in age from 30 to 51 years. All participants engaged in weekly guided sessions, daily home practice, and group discussions. The population was selected from individuals already enrolled in the program and willing to participate in data collection for observational purposes. No restrictions were placed on sex beyond adult eligibility, and participants had varying substance use histories and prior treatment experiences.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bout Me Healing

Boca Raton, Florida, 33496, United States

Location

Related Publications (1)

  • 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

    RESULT

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Cice Rivera, MS, CAP

    Bout Me Healing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

January 15, 2015

Primary Completion

March 11, 2015

Study Completion

March 11, 2016

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) from this study, including de-identified perceived stress scores, mindfulness scores, and relapse observations, will be made available upon reasonable request to qualified researchers. All data will be fully de-identified to protect participant privacy. Data requests should include a research proposal and data use agreement. The data will be available for three years following publication of the study results. The study dataset is small (three participants) and observational in nature; requests will be reviewed to ensure ethical use and protection of participant confidentiality.

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
The individual participant data (IPD) and supporting documents will be available starting from the date the study record becomes publicly accessible on ClinicalTrials.gov and will remain available for three years following publication.
Access Criteria
IPD will be accessible to qualified researchers who submit a request with a research proposal and agree to a data use agreement. Available materials include de-identified participant data (stress scores, mindfulness scores, relapse observations), the study protocol, and the clinical study report. Data access will be granted following review to ensure ethical use and confidentiality protection.
More information

Available IPD Datasets

Study Protocol Access
Clinical Study Report (MMRP_SUD_IPD_2025)Access

Locations