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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04589117
Other study ID # Pro00105586
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 27, 2020
Est. completion date August 2, 2020

Study information

Verified date November 2021
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the impact of a 4-week, virtually-delivered expressive writing intervention on resilience in a cohort of parents and caregivers currently navigating the COVID-19 pandemic during spring & summer of 2020.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date August 2, 2020
Est. primary completion date August 2, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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: Week 1: Writing to expressive difficult emotions Week 2: Writing to cultivate compassion & forgiveness Week 3: Writing to nurture positive emotions Week 4: 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 (PSS-10) 3 months
Secondary Depression symptoms Center for Epidemiologic Studies Depression Scale Revised (CESDR) 3 months
Secondary Parental stress Internal, non-validated questionnaire re. experience of parental stress 3 months