Clinical trial NCT04589104: Expressive Writing for COVID-19 Resilience
Official title: Expressive Writing for COVID-19 Resilience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distress Due to COVID-19
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Resilience
timeFrame: 3 months
Secondary outcomes:
measure: Perceived stress
timeFrame: 3 months
measure: Depression symptoms
timeFrame: 3 months
measure: Post-traumatic growth
timeFrame: 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Integrative Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: Oliver Glass, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bechard E, Evans J, Cho E, Lin Y, Kozhumam A, Jones J, Grob S, Glass O. Feasibility, acceptability, and potential effectiveness of an online expressive writing intervention for COVID-19 resilience. Complement Ther Clin Pract. 2021 Nov;45:101460. doi: 10.1016/j.ctcp.2021.101460. Epub 2021 Jul 27.