Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-29 @ 1:51 PM
Study NCT ID:
NCT05786508
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2023-02-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], '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': 'D001416', 'term': 'Back Pain'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lein0122@umn.edu', 'phone': '6126266477', 'title': 'Brent Leininger', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '9 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Partners4Pain Program', 'description': 'Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises. The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 8, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Key to Wellbeing Program', 'description': 'Keys to Wellbeing is a general health and wellbeing education program addressing topics such as keeping socially connected, finding meaning and purpose, addressing mental health, and keeping physically fit. The program was designed to control for time, attention, and many other key contextual factors (e.g., program format, materials). The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 14, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Worsening back or neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased muscle soreness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling more upset than usual when reminded of the past', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased feelings of sadness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increased feelings of anxiousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling more tired or fatigued than usual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling more isolated or lonely', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hip Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Motor Vehicle Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Recruitment Feasibility: # of Enrolled Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Participants', 'description': 'Individuals enrolled into the randomized trial'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months', 'description': 'Demonstrate the ability to recruit and retain subjects in the clinical study as follows: Randomize at least 30 participants', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Recruitment Feasibility: % of Enrolled Participants From NIH-defined Racial or Ethnic Disparity Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Participants', 'description': 'Individuals enrolled into the randomized trial'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months', 'description': 'Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 75% or more of randomized participants are from NIH-defined racial/ethnic health disparity groups;', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Participant Retention Feasibility: Primary Outcome Measurement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Enrolled Participants', 'description': 'Individuals enrolled into the randomized trial'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months', 'description': 'Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 80% or more of randomized participants are retained for primary outcome measurement at the end of the study (2 month follow up) regardless of adherence to the intervention', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intervention Delivery Feasibility: Participant Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Partners4Pain Program', 'description': 'Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises. 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The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks'}], 'classes': [{'title': 'Engage in 1 or more sessions', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Engage in 6 or more sessions', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 weeks', 'description': 'Demonstrate that the delivery of the intervention(s) and the control intervention(s) under study can be delivered consistently, as defined by: 85% or more of randomized participants engage in 1 or more sessions; 75% or more of randomized participants engage in at least 6 of 9 sessions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Intervention Fidelity: Facilitator Delivery of Required Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}, {'units': 'Sessions', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Partners4Pain Program', 'description': 'Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises. 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The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '9 weeks', 'description': 'Demonstrate the fidelity of the intervention(s) used in the study by: Program facilitators deliver 90% of session activities during at least 90% of sessions', 'unitOfMeasure': 'Sessions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Sessions', 'denomUnitsSelected': 'Sessions'}, {'type': 'PRIMARY', 'title': 'Data Collection Feasibility: Completion of Self-reported Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Partners4Pain Program', 'description': 'Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises. 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The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '2 months', 'description': 'Demonstrate the ability to collect study data by: 80% or more of randomized participants complete follow up at 2 months (end of the study)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Partners4Pain Program', 'description': 'Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises. 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The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 weeks', 'description': 'Demonstrate the safety and tolerability of the intervention(s) used in the study by: 75% or more of randomized participants are satisfied with assigned program', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Partners4Pain Program', 'description': 'Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises. The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks'}, {'id': 'FG001', 'title': 'Key to Wellbeing Program', 'description': 'Keys to Wellbeing is a general health and wellbeing education program addressing topics such as keeping socially connected, finding meaning and purpose, addressing mental health, and keeping physically fit. The program was designed to control for time, attention, and many other key contextual factors (e.g., program format, materials). The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Partners4Pain Program', 'description': 'Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises. The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks'}, {'id': 'BG001', 'title': 'Key to Wellbeing Program', 'description': 'Keys to Wellbeing is a general health and wellbeing education program addressing topics such as keeping socially connected, finding meaning and purpose, addressing mental health, and keeping physically fit. The program was designed to control for time, attention, and many other key contextual factors (e.g., program format, materials). The intervention program included nine, 90-minute group sessions that occurred weekly for 9 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'spread': '13.5', 'groupId': 'BG000'}, {'value': '57', 'spread': '15.9', 'groupId': 'BG001'}, {'value': '56', 'spread': '14.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'No Hispanic, Latino, or Spanish origin', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Mexican, Mexican American, Chicano', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Another Hispanic, Latino, or Spanish origin (e.g. Savadorian, Dominican, Columbian, Guatemalan, etc)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Ethnicity using 2020 U.S. census questionnaire', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African American (African American, Jamaican, Haitian, Nigerian, Ethiopian, Somali, etc.)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'White (German, Irish, English, Italian, Lebanese, Egyptian, etc.)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Chinese', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Asian Indian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other Asian (Pakistani, Cambodian, Hmong, etc.)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other Race (Mestizo)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other Race (Mexican)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'More Than One Race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Race using 2020 U.S. census questionnaire', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pain, Enjoyment of Life and General Activity (PEG)', 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'spread': '2.2', 'groupId': 'BG000'}, {'value': '6.4', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '6.5', 'spread': '2.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "Three questions about the past week's pain. One question asks about pain severity and two questions ask about pain interference. Each item is rated on a 0-10 scale. Responses are added together and divided by three to get a final score ranging from 0 to 10. A higher score indicates more severe pain and pain-related interference with life and activities.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-23', 'size': 1053510, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-04T12:58', 'hasProtocol': True}, {'date': '2023-05-08', 'size': 325998, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-03T12:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2023-02-15', 'resultsFirstSubmitDate': '2024-09-20', 'studyFirstSubmitQcDate': '2023-03-24', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-05', 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment Feasibility: # of Enrolled Participants', 'timeFrame': '2 months', 'description': 'Demonstrate the ability to recruit and retain subjects in the clinical study as follows: Randomize at least 30 participants'}, {'measure': 'Recruitment Feasibility: % of Enrolled Participants From NIH-defined Racial or Ethnic Disparity Groups', 'timeFrame': '2 months', 'description': 'Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 75% or more of randomized participants are from NIH-defined racial/ethnic health disparity groups;'}, {'measure': 'Participant Retention Feasibility: Primary Outcome Measurement', 'timeFrame': '2 months', 'description': 'Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 80% or more of randomized participants are retained for primary outcome measurement at the end of the study (2 month follow up) regardless of adherence to the intervention'}, {'measure': 'Intervention Delivery Feasibility: Participant Engagement', 'timeFrame': '9 weeks', 'description': 'Demonstrate that the delivery of the intervention(s) and the control intervention(s) under study can be delivered consistently, as defined by: 85% or more of randomized participants engage in 1 or more sessions; 75% or more of randomized participants engage in at least 6 of 9 sessions'}, {'measure': 'Intervention Fidelity: Facilitator Delivery of Required Activities', 'timeFrame': '9 weeks', 'description': 'Demonstrate the fidelity of the intervention(s) used in the study by: Program facilitators deliver 90% of session activities during at least 90% of sessions'}, {'measure': 'Data Collection Feasibility: Completion of Self-reported Outcomes', 'timeFrame': '2 months', 'description': 'Demonstrate the ability to collect study data by: 80% or more of randomized participants complete follow up at 2 months (end of the study)'}, {'measure': 'Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events', 'timeFrame': '9 weeks', 'description': 'Demonstrate the safety and tolerability of the intervention(s) used in the study by: 5% or less of randomized participants experience a severe or serious adverse event related to the interventions'}, {'measure': 'Safety and Tolerability of the Interventions: Satisfaction With Program', 'timeFrame': '9 weeks', 'description': 'Demonstrate the safety and tolerability of the intervention(s) used in the study by: 75% or more of randomized participants are satisfied with assigned program'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Pain', 'Low Back Pain', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'The focus of this project is on developing and optimizing community-based programs for the self-management of back or neck pain for individuals from populations that experience health disparities (BP-PEHD). Community-engaged research approach will be used to conduct quality improvement activities that involves gathering feedback from multiple stakeholders to inform development of the study interventions and materials which will be followed by a randomized pilot study to evaluate feasibility.\n\nSupported by the National Center for Complementary and Integrative Health through the National Institutes of Health\'s HEAL initiative (https://heal.nih.gov/)"'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide a signed and dated informed consent form\n* State willingness to comply with all study procedures outlined in the consent form\n* Be 18 years of age or older\n* Have self-reported chronic back pain (defined as pain in the low or mid back, or neck pain) which has lasted for 3 months or longer\n* Have a score of 3 or higher on the self-reported Pain, Enjoyment of Life and General Activity (PEG) scale (0 to 10)\n* Be a member of one or more of the following NIH-designated health disparity populations: American Indian/Alaska Native, Asian, Black/African American, Hispanic/Latino, Native Hawaiian/Pacific Islanders, Socioeconomically disadvantaged (annual household income less than $50,000)\n\nExclusion Criteria:\n\n* Hospitalization for severe mental illness in past six months because the mindfulness and behavioral mind-body practices (e.g., meditation, progressive muscle relaxation, etc.) in the experimental intervention may aggravate symptoms of severe mental illness\n* Active psychotic symptoms, suicidal ideation, or manic episodes in the past three months for the same reasons noted in #1\n* Self-reported cancer with active treatment involving radiation or chemotherapy due to the potential for complications of their back or neck pain and impact on health outcomes\n* Dementia - Mini Mental State Exam score of 23 or lower for those with suspicion of cognitive impairment due to safety risks (e.g., not being able to follow directions for safe physical exercise)\n* Self-reported pregnancy due to the fact that back pain is often associated with pregnancy and differs from non-pregnancy related back pain and thus might have different impacts on health outcomes\n* Children under the age of 18'}, 'identificationModule': {'nctId': 'NCT05786508', 'briefTitle': 'Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain', 'orgStudyIdInfo': {'id': '1R61AT012309', 'link': 'https://reporter.nih.gov/quickSearch/1R61AT012309', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': '1R61AT012309', 'link': 'https://reporter.nih.gov/quickSearch/1R61AT012309', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Partners4Pain program', 'description': 'adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status', 'interventionNames': ['Other: Partners4Pain program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Key to Wellbeing program', 'description': 'adults with chronic neck or back pain from populations that experience health disparities due to race/ethnicity or socioeconomic status', 'interventionNames': ['Other: Key to Wellbeing program']}], 'interventions': [{'name': 'Partners4Pain program', 'type': 'OTHER', 'description': 'Partners4Pain is a self-management program of evidence based complementary and integrative health approaches for pain including pain education, mindfulness, cognitive behavioral approaches, and neck/back specific exercises.\n\nThe intervention program will include nine, 90-minute group sessions that occur weekly for 9 weeks', 'armGroupLabels': ['Partners4Pain program']}, {'name': 'Key to Wellbeing program', 'type': 'OTHER', 'description': 'Keys to Wellbeing is a general health and wellbeing education program addressing topics such as keeping socially connected, finding meaning and purpose, addressing mental health, and keeping physically fit. The program was designed to control for time, attention, and many other key contextual factors (e.g., program format, materials).\n\nThe intervention program will include nine, 90-minute group sessions that occur weekly for 9 weeks', 'armGroupLabels': ['Key to Wellbeing program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Roni Evans, PhD, DC,MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}, {'name': 'Brent Leininger, PhD, DC, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}