Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT06251518
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-18
First Post:
2024-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Investigating the Effectiveness of Vimida
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Fatigue symptom severity', 'timeFrame': '6 months', 'description': 'Chalder Fatigue Scale (CFQ-11). Total score ranging from 0-33; higher scores mean higher fatigue symptoms (worse outcome).'}, {'measure': 'Depressive symptoms', 'timeFrame': '6 months', 'description': 'Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome).'}, {'measure': 'Health-related quality of life', 'timeFrame': '6 months', 'description': 'Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores mean higher quality of life (better outcome).'}, {'measure': 'Functioning', 'timeFrame': '6 months', 'description': 'Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).'}, {'measure': 'Somatic symptoms', 'timeFrame': '6 months', 'description': 'Patient Health Questionnaire - 15 item version (PHQ-15). Total score ranging from 0-30; higher scores mean higher somatic symptoms (worse outcome).'}, {'measure': 'Anxiety', 'timeFrame': '6 months', 'description': 'Generalized Anxiety Disorder Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety symptoms (worse outcome).'}], 'primaryOutcomes': [{'measure': 'Fatigue symptom severity', 'timeFrame': '3 months', 'description': 'Chalder Fatigue Scale (CFQ-11). Total score ranging from 0-33; higher scores mean higher fatigue symptoms (worse outcome).'}], 'secondaryOutcomes': [{'measure': 'Depressive symptoms', 'timeFrame': '3 months', 'description': 'Patient Health Questionnaire - 9 item version (PHQ-9). Total score ranging from 0-27; higher scores mean higher depressive symptoms (worse outcome).'}, {'measure': 'Health-related quality of life', 'timeFrame': '3 months', 'description': 'Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores mean higher quality of life (better outcome).'}, {'measure': 'Functioning', 'timeFrame': '3 months', 'description': 'Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).'}, {'measure': 'Somatic symptoms', 'timeFrame': '3 months', 'description': 'Patient Health Questionnaire - 15 item version (PHQ-15). Total score ranging from 0-30; higher scores mean higher somatic symptoms (worse outcome).'}, {'measure': 'Anxiety', 'timeFrame': '3 months', 'description': 'Generalized Anxiety Disorder Assessment (GAD-7). Total score ranging from 0-21; higher scores mean higher anxiety symptoms (worse outcome).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Long COVID', 'Post COVID-19 Condition']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial (RCT) with 160 patients suffering from fatigue after COVID-19 infection aims to investigate the effectiveness of the unguided digital therapeutic vimida for reducing post-COVID-19 fatigue. Inclusion criteria are: male, female or non-binary, age ≥18 years, diagnosis of post-COVID-19 fatigue, ≥3 months since the last infection with COVID-19, fatigue severity score (cut-off) of ≥ 16 on the Chalder Fatigue Scale (CFQ-11), consent to participation, and sufficient German language skills. Exclusion criteria are a known psychiatric or somatic condition that can explain the fatigue and current participation in a multidisciplinary rehabilitation program aimed to ameliorate the consequences of COVID-19.\n\nPatients will be randomized and allocated to either an intervention group, in which they will receive access to vimida in addition to treatment as usual (TAU; n=80), or to a control group, in which they will receive access to TAU only (n=80).\n\nThe primary endpoint will be fatigue symptoms with three months post-allocation (T1) being the primary time point for assessment of effectiveness. Six months post-allocation (T2) will be used as follow-up assessment of endpoints. Secondary endpoints will be depressive symptoms, mental health-related quality of life, work/social functioning, somatic symptoms, and anxiety symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male, female or non-binary\n* age ≥ 18\n* diagnosis of post-COVID-19 fatigue (ICD-10 U08.9, or U09.9 in conjunction with G93.3), secured via a telemedical visit\n* ≥ 3 months since COVID-19 infection that preceded fatigue symptoms\n* elevated levels of fatigue: cut-off of ≥ 16 on the CFQ-11\n* consent to participation\n* sufficient knowledge of the German language\n\nExclusion Criteria:\n\n* known somatic or psychiatric condition that can explain the fatigue (e.g., cancer, multiple sclerosis, severe depression)\n* current participation in a multidisciplinary rehabilitation program aimed at ameliorating the consequences of COVID-19'}, 'identificationModule': {'nctId': 'NCT06251518', 'acronym': 'InvidiCO', 'briefTitle': 'Investigating the Effectiveness of Vimida', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gaia AG'}, 'officialTitle': 'Investigating the Effectiveness of Vimida, a Digital Intervention for People Suffering From Post-viral Chronic Fatigue After COVID-19 Infection', 'orgStudyIdInfo': {'id': 'vimida RCT 2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'vimida + TAU', 'description': 'Participants allocated to the intervention group will receive access to vimida in addition to treatment as usual (TAU).\n\nvimida is a digital health application designed for individuals with post-Covid conditions who suffer from fatigue, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by vimida are psychoeducation, activity and recovery, attention, stress management, sleep management, cognitive restructuring, and social resources.\n\nThe program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivational text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.', 'interventionNames': ['Behavioral: vimida']}, {'type': 'NO_INTERVENTION', 'label': 'TAU', 'description': 'Participants allocated to the control group will receive access to treatment as usual (TAU).'}], 'interventions': [{'name': 'vimida', 'type': 'BEHAVIORAL', 'description': 'Participants will receive access to the digital health intervention vimida in addition to TAU.', 'armGroupLabels': ['vimida + TAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22085', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'GAIA', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Johanna Schröder, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical School Hamburg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gaia AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medical School Hamburg', 'class': 'OTHER'}, {'name': 'Institut Long-Covid Rostock', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}