Expressive Writing for COVID-19 Resilience for Parents

NCT ID: NCT04589117

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-27

Study Completion Date

2020-08-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parents During COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Expressive writing

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duke University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oliver Glass, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke Integrative Medicine

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Pro00105586

Identifier Type: -

Identifier Source: org_study_id