Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT06091293
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2023-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Narrative Intervention for Long COVID-19 (NICO)
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study has one arm. All participants will receive the NICO intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-05', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Personal Health Questionnarrie- 8 item (PHQ8)', 'timeFrame': 'Baseline and 3 months', 'description': 'Measurement of depression widely used in clinical and research settings'}], 'secondaryOutcomes': [{'measure': 'Generalized Anxiety Disorder- 7 item (GAD7)', 'timeFrame': 'Baseline and 3 months', 'description': 'Measurement of anxiety widely used in clinical and research settings'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Long COVID', 'Long Covid19']}, 'descriptionModule': {'briefSummary': 'This T1 proof of concept trial is designed to test the Narrative Intervention for Long COVID-19 intervention.', 'detailedDescription': 'People living with COVID19 Long Haul Syndrome frequently experience high symptom burden and problems performing basic activities of daily living. COVID19 has impacted mental health not only for people directly affected by the pandemic, including people who are living with COVID19 Long Haul Syndrome, but also those affected indirectly, putting further strain on the mental health system, which was already under stress.\n\nUnderstanding the experience of COVID 19 Long Haul Syndrome that can inform innovative and impactful ways to improve living with COVID19. Mental health providers are in high demand with an increase in burnout. One study reported 1/3 of mental health providers have experienced severe burnout since the onset of the pandemic. There are nursing staff shortages across the US, especially in rural areas. Shortages also occur within social work staff globally. There is a need to design innovative, interdisciplinary, and less time-intensive interventions to help those living with chronic illness. More people living longer with different types of illnesses and staffing shortages make traditional talk therapy interventions more challenging to deliver to more people.\n\nThis study has two specific aims:\n\nAim 1: Establish the acceptability and feasibility of an asynchronous narrative intervention for people living with long haul COVID19.\n\nAim 2: Explore themes of illness narratives of people living with long haul COVID19'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with Long COVID\n* Have access to email weekly\n* Between the ages of 18-89 years old\n\nExclusion Criteria:\n\n* Conflicting research study'}, 'identificationModule': {'nctId': 'NCT06091293', 'acronym': 'NICO', 'briefTitle': 'Narrative Intervention for Long COVID-19 (NICO)', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Narrative Intervention for Long COVID-19 (NICO) Research Study', 'orgStudyIdInfo': {'id': '22-0701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NICO', 'description': 'The NICO intervention includes components of narrative-informed interventions, brief solution-focused therapy, and medical social work case management to examine adjustment to illness for people living with Long COVID.', 'interventionNames': ['Behavioral: Narrative Intervention for Long COVID-19 (NICO)']}], 'interventions': [{'name': 'Narrative Intervention for Long COVID-19 (NICO)', 'type': 'BEHAVIORAL', 'description': 'The NICO intervention was delivered by a licensed psychotherapist asynchronously over a 3 month time period.', 'armGroupLabels': ['NICO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Rachel Johnson, PhD, LCSW', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}