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Expressive Writing for COVID-19 Resilience

Primary Purpose

Distress Due to COVID-19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expressive writing
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Distress Due to COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Duke Integrative Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Expressive writing

Arm Description

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

Outcomes

Primary Outcome Measures

Resilience
Connor-Davidson Resilience Scale (CD-RISC)

Secondary Outcome Measures

Perceived stress
Perceived Stress Scale-10 (PSS10)
Depression symptoms
Center for Epidemiologic Studies Scale - Revised (CESDR)
Post-traumatic growth
Post Traumatic Growth Inventory (PTGI)

Full Information

First Posted
October 12, 2020
Last Updated
October 14, 2020
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04589104
Brief Title
Expressive Writing for COVID-19 Resilience
Official Title
Expressive Writing for COVID-19 Resilience
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
August 17, 2020 (Actual)
Study Completion Date
August 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distress Due to COVID-19

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expressive writing
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Expressive writing
Intervention Description
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
Primary Outcome Measure Information:
Title
Resilience
Description
Connor-Davidson Resilience Scale (CD-RISC)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Perceived stress
Description
Perceived Stress Scale-10 (PSS10)
Time Frame
3 months
Title
Depression symptoms
Description
Center for Epidemiologic Studies Scale - Revised (CESDR)
Time Frame
3 months
Title
Post-traumatic growth
Description
Post Traumatic Growth Inventory (PTGI)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Glass, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Integrative Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34332289
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.
Results Reference
derived

Learn more about this trial

Expressive Writing for COVID-19 Resilience

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