NCT04589117

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

2 months

First QC Date

October 12, 2020

Last Update Submit

November 16, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Resilience

    Connor-Davidson Resilience Scale (CD-RISC)

    3 months

Secondary Outcomes (3)

  • Perceived stress

    3 months

  • Depression symptoms

    3 months

  • Parental stress

    3 months

Study Arms (1)

Expressive writing

EXPERIMENTAL

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

Behavioral: Expressive writing

Interventions

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

Expressive writing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Integrative Medicine

Durham, North Carolina, 27705, United States

Location

Study Officials

  • Oliver Glass, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 19, 2020

Study Start

May 27, 2020

Primary Completion

August 2, 2020

Study Completion

August 2, 2020

Last Updated

November 24, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations