- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04589104
Expressive Writing for COVID-19 Resilience
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
North Carolina
-
Durham, North Carolina, Förenta staterna, 27705
- Duke Integrative Medicine
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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:
|
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:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Elasticitet
Tidsram: 3 månader
|
Connor-Davidson Resilience Scale (CD-RISC)
|
3 månader
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Perceived stress
Tidsram: 3 months
|
Perceived Stress Scale-10 (PSS10)
|
3 months
|
|
Depression symptoms
Tidsram: 3 months
|
Center for Epidemiologic Studies Scale - Revised (CESDR)
|
3 months
|
|
Post-traumatic growth
Tidsram: 3 months
|
Post Traumatic Growth Inventory (PTGI)
|
3 months
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00105575
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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