Expressive Writing for COVID-19 Resilience

Distress Due to COVID-19 Clinical Trial

Official title:

Expressive Writing for COVID-19 Resilience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04589104
• Other study ID #: Pro00105575
• Status: Completed
• Phase: N/A
• Start date: May 26, 2020
• Est. completion date: August 17, 2020

Study information

• Verified date: October 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: August 17, 2020
• Est. primary completion date: August 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distress Due to COVID-19

Intervention

Behavioral:
• 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: Week 1: Writing to expressive difficult emotions Week 2: Writing to release & integrate difficult emotions Week 3: Writing to nurture gratitude Week 4: Writing to enhance strengths & resources Week 5: Writing to cultivate positive meaning & savor goodness Week 6: Writing to invite insight, perspective, & growth

Locations

Country	Name	City	State
United States	Duke Integrative Medicine	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resilience	Connor-Davidson Resilience Scale (CD-RISC)	3 months
Secondary	Perceived stress	Perceived Stress Scale-10 (PSS10)	3 months
Secondary	Depression symptoms	Center for Epidemiologic Studies Scale - Revised (CESDR)	3 months
Secondary	Post-traumatic growth	Post Traumatic Growth Inventory (PTGI)	3 months