NCT07483918

Brief Summary

This observational study evaluated a structured mindfulness-based psychoeducation program focused on emotional awareness, forgiveness, and self-awareness to reduce anxiety and support recovery from substance use in adults. Participants completed the program to assess its feasibility and impact on stress levels and coping skills.

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 Mar 2016

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2017

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 8, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

mindfulnesspsychoeducationanxiety disordersubstance usestress reductionrecoverybehavioral interventionemotional awarenesscoping skillsobservational study

Outcome Measures

Primary Outcomes (2)

  • Change in Anxiety

    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.

    Baseline, 12 weeks, 6 months, and 12 months

  • Change in Perceived Stress

    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 Outcomes (1)

  • Maintenance of Sobriety Duration Following Mindfulness-Based Psychoeducation

    Up to 12 months after baseline

Interventions

Participants engaged in a structured 12-week mindfulness-based psychoeducation program designed to improve emotional awareness, coping strategies, and long-term recovery from substance use and anxiety disorders. 12 weeks, with follow-ups at 6 months and 12 months to evaluate outcomes related to anxiety reduction, stress management, and sobriety maintenance.

Also known as: Mindfulness Program for Recovery, Forgiveness & Self-Awareness Training

Eligibility Criteria

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

Participants include adults aged 18 years and older with a history of substance use and co-occurring anxiety symptoms who participated in mindfulness-based psychoeducation as part of routine behavioral health support. The observational cohort consists of individuals who engaged in mindfulness practices and psychoeducational discussions focused on emotional regulation, stress awareness, and recovery maintenance. Data were retrospectively observed to evaluate patterns of anxiety reduction, perceived stress levels, and maintenance of sobriety over time.

You may qualify if:

  • 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

You may not qualify if:

  • Currently enrolled in a detoxification or medical stabilization program
  • Severe cognitive impairment or psychiatric instability that would prevent participation in the 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 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.

    RESULT

MeSH Terms

Conditions

Substance-Related DisordersGeneralized Anxiety DisorderAnxiety Disorders

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Cice Rivera, MS, CAP

    Bout Me Healing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 19, 2026

Study Start

March 13, 2016

Primary Completion

June 5, 2016

Study Completion

March 14, 2017

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The study does not plan to share individual participant data because the dataset is small 3 participants and contains sensitive personal health information, making it impossible to de-identify without risk of participant identification.

Available IPD Datasets

The published article summarizes the study: no participant-level data are shared (https://doi.org/10.6084/m9.fig)Access

Locations