Viewing Study NCT04589104


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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: Duke University
Organization:

Study Overview

Official Title: Expressive Writing for COVID-19 Resilience
Status: COMPLETED
Status Verified Date: 2020-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.
Detailed Description: 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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: