Substance Use Disorder (SUD)MBPASANCT07483918
Mindfulness-Based Psychoeducation With Substance Use and Anxiety Disorders
An observational study of Substance Use Disorder (SUD) and Anxiety Disorder Generalized, run by Bout Me Healing at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorder (SUD), Anxiety Disorder Generalized
- What is being tested?
- Mindfulness-Based Psychoeducation Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2016to 14 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Currently enrolled in a detoxification or medical stabilization program
- Severe cognitive impairment or psychiatric instability that would prevent participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness-Based Psychoeducation for Adults With Substance Use and Anxiety Disorders
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.
Read the 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.
- Being tested
- Mindfulness-Based Psychoeducation Program
- Keywords
- mindfulness, psychoeducation, anxiety disorder, substance use, stress reduction, recovery, behavioral intervention, emotional awareness, coping skills, observational study
- Medical subject headings
- Substance-Related Disorders, Generalized Anxiety Disorder, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Psychoeducation ProgramBehavioural
Also called Mindfulness Program for Recovery, Forgiveness & Self-Awareness Training
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Time Frame: Baseline, 12 weeks, 6 months, 12 months
Secondary outcomes (1)
Maintenance of Sobriety Duration Following Mindfulness-Based Psychoeducation
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.
Measured: Up to 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start13 Mar 2016
- Primary completion5 Jun 2016
- Study completion14 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bout Me Healing
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Cice Rivera, Bout Me Healing
- Investigators
- Cice Rivera, MS, CAP, Principal investigator, Bout Me Healing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483918
- Sponsor's protocol ID
- BMH-MBPASA-OBS-002
- Acronym
- MBPASA
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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 at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Psychoeducation for Adults With Substance Use and Anxiety Disorders
- ClinicalTrials.gov ID
- NCT07483918
- Acronym / sponsor ID
- MBPASA / BMH-MBPASA-OBS-002
- Keywords
- mindfulness, psychoeducation, anxiety disorder, substance use, stress reduction, recovery, behavioral intervention, emotional awareness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Bout Me HealingIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2016 (actual)
- Primary completion
- 5 Jun 2016 (actual)
- Study completion
- 14 Mar 2017 (actual)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Currently enrolled in a detoxification or medical stabilization program
- Severe cognitive impairment or psychiatric instability that would prevent participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Psychoeducation ProgramAlso: Mindfulness Program for Recovery, Forgiveness & Self-Awareness TrainingParticipants 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. | Behavioural | – |
Primary outcome
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.
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.
1 secondary outcome
Maintenance of Sobriety Duration Following Mindfulness-Based Psychoeducation
Time frame: Up to 12 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Results publicationRivera 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cice Rivera, MS, CAP principal investigator
Bout Me Healing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Substance Use Disorder (SUD) and Anxiety Disorder Generalized, run by Bout Me Healing at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anxiety (time frame: Baseline, 12 weeks, 6 months, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07483918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.