Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-28 @ 3:17 PM
Study NCT ID:
NCT06597032
Status:
COMPLETED
Last Update Posted:
2025-05-07
First Post:
2024-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Resilience Challenge: Fostering Emotional Resilience During a Time of National Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11659}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2024-09-11', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PROMIS Positive Affect CAT', 'timeFrame': 'At baseline, after completion of 6-8 week intervention, and 4 weeks later'}], 'secondaryOutcomes': [{'measure': 'PROMIS Depression CAT', 'timeFrame': 'At baseline, after completion of 6-8 week intervention, and 4 weeks later'}, {'measure': 'PROMIS Anxiety CAT', 'timeFrame': 'At baseline, after completion of 6-8 week intervention, and 4 weeks later'}, {'measure': 'PROMIS Meaning and Purpose CAT', 'timeFrame': 'At baseline, after completion of 6-8 week intervention, and 4 weeks later'}, {'measure': 'PROMIS Social Isolation CAT', 'timeFrame': 'At baseline, after completion of 6-8 week intervention, and 4 weeks later'}, {'measure': 'PROMIS Sleep Disturbance CAT', 'timeFrame': 'At baseline, after completion of 6-8 week intervention, and 4 weeks later'}, {'measure': 'PROMIS General Self-Efficacy CAT', 'timeFrame': 'At baseline, after completion of 6-8 week intervention, and 4 weeks later'}, {'measure': 'PROMIS General Life Satisfaction CAT', 'timeFrame': 'At baseline, after completion of 6-8 week intervention, and 4 weeks later'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positive Affect', 'Resilience Challenge', 'Positive Psychology', 'Stress'], 'conditions': ['Stress', 'Positive Affect']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to examine the effects of an online positive psychological intervention on positive emotion, anxiety, depression, feelings of social isolation, sleep disturbance and a sense of meaning and purpose in the general public. The main question it aims to answer is:\n\nWill the practice of positive emotion skills via a self-guided online platform reduce feelings of anxiety, depression, social isolation, and sleep disturbance, as well as increase well-being, positive emotion, a sense of meaning and purpose, life satisfaction, and general self-efficacy?\n\nParticipants will take part in an online positive psychological skill learning intervention for 6-8 weeks. Prior to beginning, immediately after, and 4 weeks after, participants will fill out measures of their wellbeing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years old, Access to device connected to the internet\n\nExclusion Criteria:\n\n* Under 18 years old'}, 'identificationModule': {'nctId': 'NCT06597032', 'acronym': 'FERN', 'briefTitle': 'The Resilience Challenge: Fostering Emotional Resilience During a Time of National Stress', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'The Resilience Challenge: FERN (Fostering Emotional Resilience During a Time of National Stress)', 'orgStudyIdInfo': {'id': 'STU00222090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Resilience Challenge', 'description': 'The Resilience Challenge Study is an online program containing a series of positive emotion skills for individuals experiencing stress and distress during their everyday life. The online program specifically targets positive emotion and offers an array of skills in a self-guided online delivery platform. Participants will, over the course of 6-8 weeks, access weekly skill lessons, daily homework, and daily emotion reporting. The skill lessons will include: positive events, savoring, gratitude, everyday mindfulness, mindfulness meditation, positive reappraisal, self-compassion, personal strengths, and attainable goals.', 'interventionNames': ['Behavioral: Resilience Challenge']}], 'interventions': [{'name': 'Resilience Challenge', 'type': 'BEHAVIORAL', 'description': 'We previously have tested this online program in people facing health- and work-related stressors (e.g., dementia caregivers, healthcare workers), and in 2020 we enrolled adults in a test of the online program to support coping with the stress of the COVID pandemic. This intervention has been tailored for a widespread, public audience (e.g., we have added a few other safety measures including limits on public forum posting and have clarified wording on some of the intervention content to make it clearer and easier to understand).', 'armGroupLabels': ['Resilience Challenge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06011', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Judith T Moskowitz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medical Social Sciences', 'investigatorFullName': 'Judith Moskowitz', 'investigatorAffiliation': 'Northwestern University'}}}}