- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04589117
Expressive Writing for COVID-19 Resilience for Parents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In 2016, the research team piloted a 6-week intervention on expressive writing for resilience in a population of trauma survivors. Participants self-identified as having had a recent trauma or significant life upheaval, such as a divorce, major illness, job loss, or the death of a loved one. At 6 weeks, the investigators found that participants experienced significantly improved levels of resilience and lower levels of stress, rumination, and depression. These results added to a growing body of research indicating the potential for expressive writing to be a powerful healing modality for both psychological and physical well-being.
The current COVID-19 pandemic presents the potential for trauma or significant life upheaval for nearly all members of the community and the world at large. Parents of children who are at home face unique challenges during this time. Social distancing guidelines, shelter in place protocols, school and business closures, travel restrictions, high levels of job loss, loss of childcare, and the looming threat of illness have disrupted daily routines, family life, and significantly altered life plans for many. Parents and caregivers who have unexpectedly lost childcare, are having to adjust to home schooling arrangements, and/or are having to end to heightened emotional needs in their children may experience this time as particularly difficult.
Resilience is the capacity for individuals to adapt and recover in the face of trauma, adversity, or significant sources of stress. The current collective reality magnifies the need for accessible, low-cost, effective interventions to help people cultivate resilience and other dimensions of psychological well-being.
In this study, the investigators seek to further the work the research team began in 2016 with a 4-week, virtually-delivered expressive writing intervention designed to support parents in cultivating personal resilience and emotional wellness during the COVID-19 pandemic.
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:
In order to have up to 40 evaluable subjects, we plan to consent up to 45 individuals. Potential subjects will be considered eligible if they are parents or primary caregivers of children aged 0-18 who have been home with them during the COVID-19 experience. Other eligibility criteria include:
- Able to speak, read, write, and understand English
- Cognitively able to provide consent
- Ability to participate in a 4-week intervention delivered via Zoom 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 4-week study intervention will invite participants through a progression of expressive writing exercises designed to support emotional expression and enhance personal resilience. Weekly instruction writing sessions will be conducted via Zoom. The sessions will not be recorded, but participants who cannot attend the sessions live (or prefer not to, for any reason) will receive each week's instructions and prompts via email. The progression of writing exercises flows as follows:
|
The 4-week study intervention will invite participants through a progression of expressive writing exercises designed to support emotional expression and enhance personal resilience. Weekly instruction writing sessions will be conducted via Zoom. The sessions will not be recorded, but participants who cannot attend the sessions live (or prefer not to, for any reason) will receive each week's instructions and prompts via email. 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 (PSS-10)
|
3 months
|
Depression symptoms
Time Frame: 3 months
|
Center for Epidemiologic Studies Depression Scale Revised (CESDR)
|
3 months
|
Parental stress
Time Frame: 3 months
|
Internal, non-validated questionnaire re.
experience of parental stress
|
3 months
|
Collaborators and Investigators
Sponsor
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
- Pro00105586
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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Virginia Commonwealth UniversityCompleted
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