- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07483918
Mindfulness-Based Psychoeducation With Substance Use and Anxiety Disorders (MBPASA)
Mindfulness-Based Psychoeducation for Adults With Substance Use and Anxiety Disorders
Study Overview
Status
Intervention / Treatment
Detailed Description
This study aimed to examine the effects of a mindfulness-based psychoeducation program on adults with co-occurring substance use and anxiety disorders. The program included structured sessions on mindfulness, emotional awareness, forgiveness, and self-awareness, designed to help participants manage stress, improve coping skills, and support long-term recovery. Participants engaged in guided exercises, group discussions, and reflective practices to reinforce these skills.
The study employed an observational, single-group design with open-label procedures. Three adult participants were enrolled, all meeting criteria for a diagnosis of substance use disorder and an anxiety disorder, excluding individuals currently in detoxification. The primary outcomes measured were reductions in stress and anxiety levels, as well as improvements in coping strategies related to substance use recovery. Secondary outcomes included participant engagement, self-reported mindfulness skills, and perceived emotional well-being.
Participants engaged in a 12-week structured mindfulness-based psychoeducation program designed to improve emotional awareness, coping strategies, and long-term recovery. The intervention incorporated guided mindfulness exercises, forgiveness practices, and self-awareness training to help participants manage anxiety and substance use. Assessments were conducted at baseline, program completion (12 weeks), and follow-up at 6 months and 12 months to measure outcomes related to stress, anxiety, and sobriety maintenance.
The study was conducted in Boca Raton, FL, and has been completed. Data from this pilot program provides preliminary insights into the feasibility and potential benefits of mindfulness-based psychoeducation for supporting recovery and mental health in adults with dual diagnoses.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
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Boca Raton, Florida, United States, 33496
- Bout Me Healing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults 18 years or older
- Diagnosed with a substance use disorder
- Diagnosed with an anxiety disorder
- Able and willing to participate in mindfulness-based psychoeducation sessions
Exclusion Criteria:
- Currently enrolled in a detoxification or medical stabilization program
- Severe cognitive impairment or psychiatric instability that would prevent participation in the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Anxiety
Time Frame: Baseline, 12 weeks, 6 months, and 12 months
|
Measure: State-Trait Anxiety Inventory (STAI) Description: Participants' anxiety levels will be assessed using the validated State-Trait Anxiety Inventory (STAI).
Changes in STAI scores will be observed across assessment intervals to evaluate patterns of anxiety reduction associated with mindfulness-based psychoeducation.
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Baseline, 12 weeks, 6 months, and 12 months
|
|
Change in Perceived Stress
Time Frame: Time Frame: Baseline, 12 weeks, 6 months, 12 months
|
Measure: Perceived Stress Scale (PSS) Description: Participants' perceived stress levels will be assessed using the validated Perceived Stress Scale (PSS).
Changes in PSS scores will be observed across assessment intervals to evaluate patterns of stress reduction associated with mindfulness-based psychoeducation.
|
Time Frame: Baseline, 12 weeks, 6 months, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maintenance of Sobriety Duration Following Mindfulness-Based Psychoeducation
Time Frame: Up to 12 months after baseline
|
Maintenance of sobriety will be evaluated through participant self-report of continued abstinence from substances following participation in mindfulness-based psychoeducation.
Duration of sobriety will be documented at follow-up intervals to observe patterns of sustained recovery, emotional stability, and relapse prevention associated with mindfulness-based behavioral support.
|
Up to 12 months after baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Cice Rivera, MS, CAP, Bout Me Healing
Publications and helpful links
General Publications
- Rivera C. Mindfulness-Based Psychoeducation to Reduce Anxiety and Support Recovery in Adults with Substance Use Disorders: A Pilot Observational Study. Journal of Psychology, Recovery & Forensic Research. 2026 March. doi: 10.6084/m9.figshare.31567039.
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-MBPASA-OBS-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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The published article summarizes the study: no participant-level data are shared
Information identifier: https://doi.org/10.6084/m9.figInformation comments: The published article summarizes the study methodology and results. No individual participant- level data are shared due to confidentiality. The article provides all information needed.
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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