- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04589104
Expressive Writing for COVID-19 Resilience
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke Integrative Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resilience
Time Frame: 3 months
|
Connor-Davidson Resilience Scale (CD-RISC)
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived stress
Time Frame: 3 months
|
Perceived Stress Scale-10 (PSS10)
|
3 months
|
Depression symptoms
Time Frame: 3 months
|
Center for Epidemiologic Studies Scale - Revised (CESDR)
|
3 months
|
Post-traumatic growth
Time Frame: 3 months
|
Post Traumatic Growth Inventory (PTGI)
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00105575
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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