Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:36 AM
Study NCT ID:
NCT07483918
Status:
COMPLETED
Last Update Posted:
2026-03-19
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness-Based Psychoeducation With Substance Use and Anxiety Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D000098647', 'term': 'Generalized Anxiety Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016879', 'term': 'Salvage Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Anxiety', 'timeFrame': 'Baseline, 12 weeks, 6 months, and 12 months', 'description': "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."}, {'measure': 'Change in Perceived Stress', 'timeFrame': 'Time Frame: Baseline, 12 weeks, 6 months, 12 months', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Maintenance of Sobriety Duration Following Mindfulness-Based Psychoeducation', 'timeFrame': 'Up to 12 months after baseline', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mindfulness', 'psychoeducation', 'anxiety disorder', 'substance use', 'stress reduction', 'recovery', 'behavioral intervention', 'emotional awareness', 'coping skills', 'observational study'], 'conditions': ['Substance Use Disorder (SUD)', 'Anxiety Disorder Generalized']}, 'referencesModule': {'availIpds': [{'id': 'https://doi.org/10.6084/m9.fig', 'url': 'https://bout-me-healing.com/2026/03/08/mindfulness-based-psychoeducation-observational-study/', 'type': 'The published article summarizes the study: no participant-level data are shared', 'comment': '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.'}], 'references': [{'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nParticipants 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18 years or older\n* Diagnosed with a substance use disorder\n* Diagnosed with an anxiety disorder\n* Able and willing to participate in mindfulness-based psychoeducation sessions\n\nExclusion Criteria:\n\n* Currently enrolled in a detoxification or medical stabilization program\n* Severe cognitive impairment or psychiatric instability that would prevent participation in the study'}, 'identificationModule': {'nctId': 'NCT07483918', 'acronym': 'MBPASA', 'briefTitle': 'Mindfulness-Based Psychoeducation With Substance Use and Anxiety Disorders', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bout Me Healing'}, 'officialTitle': 'Mindfulness-Based Psychoeducation for Adults With Substance Use and Anxiety Disorders', 'orgStudyIdInfo': {'id': 'BMH-MBPASA-OBS-002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mindfulness-Based Psychoeducation Program', 'type': 'BEHAVIORAL', 'otherNames': ['Mindfulness Program for Recovery', 'Forgiveness & Self-Awareness Training'], 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33496', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Bout Me Healing', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}], 'overallOfficials': [{'name': 'Cice Rivera, MS, CAP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bout Me Healing'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bout Me Healing', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cice Rivera', 'investigatorAffiliation': 'Bout Me Healing'}}}}