Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT05005351
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2021-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia
Sponsor:
Organization:
Raw JSON
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their non-pharmacological and pharmacological treatment as usual.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 7, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Digital Symptom Tracker Arm', 'description': 'Digital Symptom Tracker: Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 3, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis in Face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post COVID-19 Vaccination Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Broken Foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Worsening Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of Gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Exacerbation of Fibromyalgia Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left Side Rib Contusions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Acceptance and Commitment Therapy (ACT) Arm', 'description': 'Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.'}, {'id': 'OG001', 'title': 'Digital Symptom Tracker Arm', 'description': 'Digital Symptom Tracker: Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.7', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '-3.0', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement", 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital Acceptance and Commitment Therapy (ACT) Arm', 'description': 'Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.'}, {'id': 'OG001', 'title': 'Digital Symptom Tracker Arm', 'description': 'Digital Symptom Tracker: Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': 'PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Digital Acceptance and Commitment Therapy (ACT) Arm', 'description': 'Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.'}, {'id': 'FG001', 'title': 'Digital Symptom Tracker Arm', 'description': 'Digital Symptom Tracker: Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Digital Acceptance and Commitment Therapy (ACT)', 'description': 'Digital ACT: Participants in Digital ACT complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.'}, {'id': 'BG001', 'title': 'Digital Symptom Tracker Arm', 'description': 'Digital Symptom Tracker: Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.2', 'spread': '10.5', 'groupId': 'BG000'}, {'value': '53.6', 'spread': '10.1', 'groupId': 'BG001'}, {'value': '52.8', 'spread': '10.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2021-01-10', 'size': 192727, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-12T18:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-12', 'studyFirstSubmitDate': '2021-08-10', 'resultsFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2021-08-10', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-12', 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Revised Fibromyalgia Impact Questionnaire (FIQ-R) Total Score', 'timeFrame': 'Baseline to Week 12', 'description': 'FIQ-R total score ranges between 0-100 with a reduction in score indicating reduced fibromyalgia severity.'}], 'secondaryOutcomes': [{'measure': "Key Secondary Endpoint of This Clinical Trial - Rate of Patient's Global Impression of Change (PGIC) Responders at Week 12 - Any Improvement", 'timeFrame': 'Week 12', 'description': 'PGIC scores included are: Very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Fibromyalgia']}, 'referencesModule': {'references': [{'pmid': '37382794', 'type': 'RESULT', 'citation': 'Catella S, Gendreau RM, Kraus AC, Vega N, Rosenbluth MJ, Soefje S, Malhotra S, Luciano JV, McCracken LM, Williams DA, Arnold LM. Self-guided digital acceptance and commitment therapy for fibromyalgia management: results of a randomized, active-controlled, phase II pilot clinical trial. J Behav Med. 2024 Feb;47(1):27-42. doi: 10.1007/s10865-023-00429-3. Epub 2023 Jun 29.'}], 'seeAlsoLinks': [{'url': 'https://www.swingtherapeutics.com/', 'label': 'Swing Therapeutics Website'}]}, 'descriptionModule': {'briefSummary': 'This is a non-significant risk, multi-center, randomized, active-controlled study to compare the effectiveness of two digital therapies in the management of fibromyalgia over 12 weeks. The primary endpoint is mean change from baseline to Week 12 in the weekly revised Fibromyalgia Impact Questionnaire (FIQ-R) total score.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Subject is 22 to 75 years of age, inclusive\n2. Subject has a diagnosis of primary FM as defined by the 2016 American College of Rheumatology Preliminary Diagnostic Criteria for FM, which requires satisfaction of the following criteria:\n\n 1. Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5, OR WPI 4-6 and SS scale score ≥9;\n 2. Symptoms have been present at a similar level for at least 3 months;\n 3. Pain must be present in at least 4 out of 5 body regions\n3. Subject with ongoing treatments should be on stable therapy for 30 days prior to screening appointment.\n4. Subject is capable of reading and understanding English and has provided written informed consent to participate.\n\nKey Exclusion Criteria:\n\n1. Lifetime history of bipolar disorder as assessed by the MINI.\n2. Current, untreated, major depressive episode and/or anxiety disorders as assessed by the MINI.\n3. Subject has a BDI-II total score \\> 25 at either the Screening appointment or Baseline appointment.\n4. The subject is at increased risk of suicide on the basis of the investigator\'s judgment, a response \\> 1 to BDI item #9, or the results of the Columbia-Suicide Severity Rating Scale ("C-SSRS") conducted at Screening or Baseline (i.e., any suicidal behavior during the preceding year or C-SSRS Type 3, 4, or 5 suicidal ideation during the preceding year).\n5. Subject has any other disease or medical condition that, in the opinion of the Investigator or Sponsor, could endanger the subject, interfere with the evaluation of the study device\'s efficacy or safety, or compromise the subject\'s ability to comply with/complete the study.'}, 'identificationModule': {'nctId': 'NCT05005351', 'acronym': 'SMART-FM', 'briefTitle': '"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia', 'organization': {'class': 'OTHER', 'fullName': 'Swing Therapeutics, Inc.'}, 'officialTitle': '"SMART-FM": Smart-Phone Based Digital Therapeutic for Management of Fibromyalgia', 'orgStudyIdInfo': {'id': 'Swing-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Digital Acceptance and Commitment Therapy (ACT)', 'interventionNames': ['Device: Digital ACT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Digital Symptom Tracker', 'interventionNames': ['Device: Digital Symptom Tracker']}], 'interventions': [{'name': 'Digital ACT', 'type': 'DEVICE', 'description': 'Participants in Digital ACT arm complete daily ACT lessons and activities and continue their non-pharmacological and pharmacological treatment as usual.', 'armGroupLabels': ['Digital Acceptance and Commitment Therapy (ACT)']}, {'name': 'Digital Symptom Tracker', 'type': 'DEVICE', 'description': 'Participants in the Digital Symptom Tracker arm complete daily symptom and function tracking, have access to digital fibromyalgia and health education, and continue their non-pharmacological and pharmacological treatment as usual.', 'armGroupLabels': ['Digital Symptom Tracker']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'Excell Research, Inc.', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '95831', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Superior Research LLC', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Neuroscience Solutions, Inc.', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '14221', 'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': 'Upstate Clinical Research Associates LLC', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Physicians Company, LLC', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44720', 'city': 'North Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neuro-Behavioral Clinical Research, Inc.', 'geoPoint': {'lat': 40.87589, 'lon': -81.40234}}, {'zip': '18104', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Center for Clinical Research', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}], 'overallOfficials': [{'name': 'Michael Gendreau, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Consulting Chief Medical Officer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swing Therapeutics, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}