- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04589104
Expressive Writing for COVID-19 Resilience
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Eligible 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.
The 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.
The 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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North Carolina
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Durham, North Carolina, Forenede Stater, 27705
- Duke Integrative Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Potential subjects will be considered eligible if they feel they have been personally impacted by circumstances surrounding COVID-19. Other eligibility criteria include:
- Able to speak, read, write, and understand English
- Cognitively able to provide consent
- Ability to participate in a 6-week intervention delivered via Zoom, REDCap, and email
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Expressive writing
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:
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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:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Modstandsdygtighed
Tidsramme: 3 måneder
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Connor-Davidson Resilience Scale (CD-RISC)
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3 måneder
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Perceived stress
Tidsramme: 3 months
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Perceived Stress Scale-10 (PSS10)
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3 months
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Depression symptoms
Tidsramme: 3 months
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Center for Epidemiologic Studies Scale - Revised (CESDR)
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3 months
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Post-traumatic growth
Tidsramme: 3 months
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Post Traumatic Growth Inventory (PTGI)
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3 months
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00105575
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Distress Due to COVID-19
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Szeged UniversityAfsluttetHåndteringsevne | Humør | Covid-19-pandemi | Psykologisk stress | Subjektiv helbredsklage | Spørgeskemadesign | To-item skala for generaliseret angstlidelse | Patientsundhedsspørgeskema Angst- og depressionsskala | SundhedsstatusindeksUngarn
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PfizerAktiv, ikke rekrutterendeCOVID-19 | Coronavirus sygdom 2019 (COVID-19) | Covid-19-infektion | Vacciner mod covid-19 | SARS-CoV-2-infektion, COVID19 | COVID-19-vaccination | SARS-CoV-2-infektion, COVID-19 | COVID-19 (Coronavirus sygdom 2019) | COVID-19 SARS-CoV-2-infektionForenede Stater
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PfizerRekrutteringLuftvejssygdomme | COVID-19 | Lungebetændelse | Lungesygdomme | Coronavirussygdom 2019 | Coronavirus sygdom 2019 (COVID-19) | Covid-19-infektion | Øvre luftvejsinfektioner | Luftvejsinfektion | COVID-19 (Coronavirus sygdom 2019) | COVID-19 SARS-CoV-2-infektionBelgien
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Shanghai Public Health Clinical CenterIkke rekrutterer endnu
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Duke UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Afsluttet
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Eggensberger OHGBavarian Health and Food Safety Authority (LGL)RekrutteringTilstand efter COVID-19 | Efter COVID-19 | Post COVID-19 syndrom | Langt COVID-19 syndrom | Post COVID-19 tilstand (PCC)Tyskland
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Yang I. PachankisAktiv, ikke rekrutterendeCOVID-19 luftvejsinfektion | COVID-19 stresssyndrom | COVID-19-vaccinebivirkning | COVID-19-associeret tromboembolisme | COVID-19 Post-Intensive Care Syndrome | COVID-19-associeret slagtilfældeKina
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University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico og andre samarbejdspartnereAfsluttetPostakutte følgesygdomme af COVID-19 | Tilstand efter COVID-19 | Langtids-COVID | Kronisk COVID-19 syndromItalien
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University of Missouri, Kansas CityNational Institute on Minority Health and Health Disparities (NIMHD)Aktiv, ikke rekrutterendeCovid-19 testadfærdForenede Stater
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Lawson Research Institute of St. Joseph'sCanadian Institutes of Health Research (CIHR); Western University, CanadaRekrutteringTræthed | Post-COVID-19 syndrom | Tilstand efter COVID-19 | Post-COVID syndrom | Lang COVID-19 | Langtids-COVID | Post-COVID tilstandCanada
Kliniske forsøg med Expressive writing
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Black Hills State UniversityNational Institute of General Medical Sciences (NIGMS)AfsluttetAkut smerte | Følelser | Positiv tænkningForenede Stater
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Duke UniversityAfsluttetModstandsdygtighedForenede Stater