Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-02 @ 3:14 PM
Study NCT ID:
NCT02602535
Status:
COMPLETED
Last Update Posted:
2025-04-22
First Post:
2015-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012657', 'term': 'Self-Help Groups'}], 'ancestors': [{'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-01', 'size': 1107673, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-31T14:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2015-10-26', 'studyFirstSubmitQcDate': '2015-11-09', 'lastUpdatePostDateStruct': {'date': '2025-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in nonreactivity', 'timeFrame': 'Change from baseline through post-treatment (8 weeks from beginning of treatment)', 'description': 'subscale on Five Facet Mindfulness Questionnaire'}, {'measure': 'Change in interoceptive awareness', 'timeFrame': 'Change from baseline through post-treatment (8 weeks from beginning of treatment)', 'description': 'Interoceptive awareness as evidenced by the Multidimensional Assessment of Interoceptive Awareness'}, {'measure': 'Change in reinterpretation of pain sensations', 'timeFrame': 'Change from baseline through post-treatment (8 weeks from beginning of treatment)', 'description': 'Reinterpretation of pain sensations subscale on the Coping Strategies Questionnaire'}, {'measure': 'Change in emotion regulation', 'timeFrame': 'Change from baseline through post-treatment (8 weeks from beginning of treatment)', 'description': 'Emotion regulation as evidenced by responses on the Emotion Regulation Task'}, {'measure': 'Change in positive emotion', 'timeFrame': 'Change from baseline through post-treatment (8 weeks from beginning of treatment)', 'description': 'Positive emotion as evidenced by the PANAS'}, {'measure': 'Change in cue-reactivity', 'timeFrame': 'Change from baseline through post-treatment (8 weeks from beginning of treatment)', 'description': 'Cue-reactivity as evidenced by attentional bias and central-autonomic responses during cue-exposure'}, {'measure': 'Change in attention to positive information', 'timeFrame': 'Change from baseline through post-treatment (8 weeks from beginning of treatment)', 'description': 'Attention to positive information as evidenced by the APNIS'}, {'measure': 'Change in anhedonia', 'timeFrame': 'Change from baseline through study completion (9 months post-treatment)', 'description': 'Anhedonia as evidenced by the Snaith Hamilton Anhedonia and Pleasure Scale (SHAPS), from 14 to 56, with lower scores meaning less anhedonia.'}], 'primaryOutcomes': [{'measure': 'Change in opioid misuse', 'timeFrame': 'Change from baseline through study completion (9 months post-treatment)', 'description': 'Opioid misuse as evidenced by triangulated aggregate of Current Opioid Misuse Measure and/or clinician assessment via Addiction Behaviors Checklist and/or urine screen'}, {'measure': 'Change in pain severity and interference', 'timeFrame': 'Change from baseline through study completion (9 months post-treatment)', 'description': 'Brief Pain Inventory'}], 'secondaryOutcomes': [{'measure': 'Change in opioid craving', 'timeFrame': 'Change from baseline through study completion (9 months post-treatment)', 'description': 'Opioid craving measure from Wasan et al. 2012'}, {'measure': 'Change in psychological distress', 'timeFrame': 'Change from baseline through study completion (9 months post-treatment)', 'description': 'Depression Anxiety Stress Scale'}, {'measure': 'Change in opioid dose', 'timeFrame': 'Change from baseline through study completion (9 months post-treatment)', 'description': 'Opioid dose converted into morphine equivalents via standardized equianalgesic tables'}]}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Opioid Use Disorders']}, 'referencesModule': {'references': [{'pmid': '40305010', 'type': 'DERIVED', 'citation': 'Garland EL, Hudak J, Hanley AW, Bernat E, Froeliger B. Positive Emotion Dysregulation in Opioid Use Disorder and Normalization by Mindfulness-Oriented Recovery Enhancement: A Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2025 Jul 1;82(7):654-662. doi: 10.1001/jamapsychiatry.2025.0569.'}, {'pmid': '35226053', 'type': 'DERIVED', 'citation': 'Garland EL, Hanley AW, Nakamura Y, Barrett JW, Baker AK, Reese SE, Riquino MR, Froeliger B, Donaldson GW. Mindfulness-Oriented Recovery Enhancement vs Supportive Group Therapy for Co-occurring Opioid Misuse and Chronic Pain in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2022 Apr 1;182(4):407-417. doi: 10.1001/jamainternmed.2022.0033.'}]}, 'descriptionModule': {'briefSummary': 'The central aim of this study is to test the efficacy of Mindfulness-Oriented Recovery Enhancement (MORE), an intervention designed to disrupt the risk chain leading from chronic pain to prescription opioid misuse and addiction. The investigators plan to conduct a full scale clinical trial to determine whether MORE (relative to a support group control condition) can reduce symptoms of chronic pain and opioid misuse among patients who are receiving pain management in primary care via long-term opioid analgesic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-60+\n* Current back pain diagnosis as determined from ICD-9 codes in claims data (including but not limited to ICD-9 diagnoses 724.x, or 847.x) or current chronic pain diagnosis determined by physician assessment (including but not limited to ICD-9 diagnoses 338.0, 338.21, 338.22, 338.28, 338.29, 338.4)\n* Current use of prescription opioid agonist or mixed agonist-antagonist analgesics for \\>90 days, and evidence of opioid misuse as indicated by the Current Opioid Misuse Measure\n* Willingness to participate in study interventions and assessments\n\nExclusion Criteria:\n\n* Prior experience with Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, or Mindfulness-Based Relapse Prevention\n* Active suicidality, schizophrenia, psychotic disorder, and/or substance dependence (other than opioid dependence)\n* Presence of clinically unstable systemic illness judged to interfere with treatment'}, 'identificationModule': {'nctId': 'NCT02602535', 'briefTitle': 'Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Mindfulness-Oriented Recovery Enhancement For Chronic Pain and Prescription Opioid Misuse in Primary Care', 'orgStudyIdInfo': {'id': '00078615'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'M.O.R.E.', 'description': 'Participants will attend a Mindfulness-Oriented Recovery Enhancement (MORE) group weekly for eight weeks.', 'interventionNames': ['Behavioral: Mindfulness-Oriented Recovery Enhancement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Support Group', 'description': 'Participants will attend a support group weekly for eight weeks.', 'interventionNames': ['Behavioral: Support Group']}], 'interventions': [{'name': 'Mindfulness-Oriented Recovery Enhancement', 'type': 'BEHAVIORAL', 'description': 'Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.', 'armGroupLabels': ['M.O.R.E.']}, {'name': 'Support Group', 'type': 'BEHAVIORAL', 'description': 'A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.', 'armGroupLabels': ['Support Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Primary Care Clinics', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Eric Garland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}