Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-25 @ 7:08 PM
Study NCT ID:
NCT04589104
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2020-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expressive Writing for COVID-19 Resilience
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': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-14', 'studyFirstSubmitDate': '2020-10-12', 'studyFirstSubmitQcDate': '2020-10-14', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resilience', 'timeFrame': '3 months', 'description': 'Connor-Davidson Resilience Scale (CD-RISC)'}], 'secondaryOutcomes': [{'measure': 'Perceived stress', 'timeFrame': '3 months', 'description': 'Perceived Stress Scale-10 (PSS10)'}, {'measure': 'Depression symptoms', 'timeFrame': '3 months', 'description': 'Center for Epidemiologic Studies Scale - Revised (CESDR)'}, {'measure': 'Post-traumatic growth', 'timeFrame': '3 months', 'description': 'Post Traumatic Growth Inventory (PTGI)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Distress Due to COVID-19']}, 'referencesModule': {'references': [{'pmid': '34332289', 'type': 'DERIVED', 'citation': 'Bechard E, Evans J, Cho E, Lin Y, Kozhumam A, Jones J, Grob S, Glass O. Feasibility, acceptability, and potential effectiveness of an online expressive writing intervention for COVID-19 resilience. Complement Ther Clin Pract. 2021 Nov;45:101460. doi: 10.1016/j.ctcp.2021.101460. Epub 2021 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the impact of a 6-week, virtually-delivered expressive writing intervention on resilience in a cohort of individuals currently navigating the COVID-19 pandemic during spring 2020.', 'detailedDescription': 'The purpose of this study is to determine the impact of a 6-week, virtually-delivered expressive writing intervention on resilience in a cohort of individuals currently navigating the COVID-19 pandemic during spring 2020.\n\nEligible subjects will be adults who are able to read and write in English and are cognitively able to provide informed consent. Potential subjects will be recruited through the Duke Health \\& Well-Being email lists. The entirely virtual 6-week expressive writing intervention will be delivered via Zoom, REDCap, and email, and subjects will complete measures at baseline, 6 weeks, and 10 weeks (1 month post-intervention). Each week of the intervention will invite participants to complete a series of expressive writing assignments designed to support emotional expression and cultivate resilience, and the assignments will take approximately 60-90 minutes each week to complete.\n\nThe primary outcome is the 25-item Connor-Davidson Resilience Scale (CD-RISC). Other measures will include a basic demographics survey, questions about COVID-19 impact, post-writing surveys collected after the writing assignments, the 10-item Perceived Stress Scale (PSS), the Center for Epidemiologic Studies Depression Scale-Revised, and the 21-item Post -Traumatic Growth Inventory (PTGI). Participants will also have the option to share the content of their writing assignments with the research team if they choose.\n\nThe risks of participation in this study are minimal and include the risk of mild sadness after the writing assignments and the risk of loss of confidentiality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPotential subjects will be considered eligible if they feel they have been personally impacted by circumstances surrounding COVID-19. Other eligibility criteria include:\n\n* Able to speak, read, write, and understand English\n* Cognitively able to provide consent\n* Ability to participate in a 6-week intervention delivered via Zoom, REDCap, and email'}, 'identificationModule': {'nctId': 'NCT04589104', 'briefTitle': 'Expressive Writing for COVID-19 Resilience', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Expressive Writing for COVID-19 Resilience', 'orgStudyIdInfo': {'id': 'Pro00105575'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Expressive writing', 'description': 'The expressive writing intervention consists of a 6-week, virtually-delivered writing program. Each week, participants meet for 90 minutes via Zoom and will be guided through writing prompts designed to encourage emotional expression and enhance personal resilience. The progression of writing exercises flows as follows:\n\n* Week 1: Writing to expressive difficult emotions\n* Week 2: Writing to release \\& integrate difficult emotions\n* Week 3: Writing to nurture gratitude\n* Week 4: Writing to enhance strengths \\& resources\n* Week 5: Writing to cultivate positive meaning \\& savor goodness\n* Week 6: Writing to invite insight, perspective, \\& growth', 'interventionNames': ['Behavioral: Expressive writing']}], 'interventions': [{'name': 'Expressive writing', 'type': 'BEHAVIORAL', 'description': 'The expressive writing intervention consists of a 6-week, virtually-delivered writing program. Each week, participants meet for 90 minutes via Zoom and will be guided through writing prompts designed to encourage emotional expression and enhance personal resilience. The progression of writing exercises flows as follows:\n\n* Week 1: Writing to expressive difficult emotions\n* Week 2: Writing to release \\& integrate difficult emotions\n* Week 3: Writing to nurture gratitude\n* Week 4: Writing to enhance strengths \\& resources\n* Week 5: Writing to cultivate positive meaning \\& savor goodness\n* Week 6: Writing to invite insight, perspective, \\& growth', 'armGroupLabels': ['Expressive writing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Integrative Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Oliver Glass, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}