Distress Due to COVID-19NCT04589104
Expressive Writing for COVID-19 Resilience
A study testing Expressive writing in people with Distress Due to COVID-19, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Distress Due to COVID-19
- What is being tested?
- Expressive writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2020to 17 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Integrative Medicine
Durham, North Carolina, 27705
About this study
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.
Read the 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.
- Conditions
- Distress Due to COVID-19
- Being tested
- Expressive writing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Expressive writing | Experimental | 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 Receives: Behavioral: Expressive writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience
Connor-Davidson Resilience Scale (CD-RISC)
Measured: 3 months
Secondary outcomes (3)
Perceived stress
Perceived Stress Scale-10 (PSS10)
Measured: 3 months
Depression symptoms
Center for Epidemiologic Studies Scale - Revised (CESDR)
Measured: 3 months
Post-traumatic growth
Post Traumatic Growth Inventory (PTGI)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start26 May 2020
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distress Due to COVID-19Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Glass, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589104
- Sponsor's protocol ID
- Pro00105575
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34332289
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expressive Writing for COVID-19 Resilience
- ClinicalTrials.gov ID
- NCT04589104
- Acronym / sponsor ID
- Pro00105575
- Conditions
- Distress Due to COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expressive writing | Experimental | Behavioral: Expressive writingThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive writingThe 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 | Behavioural | Expressive writing |
Primary outcome
Resilience
Time frame: 3 months
Connor-Davidson Resilience Scale (CD-RISC)
3 secondary outcomes
Perceived stress
Time frame: 3 months
Depression symptoms
Time frame: 3 months
Post-traumatic growth
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 34332289Bechard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Glass, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive writing in people with Distress Due to COVID-19, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04589104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.