Let It Out (LIO) and COVID19: Testing an Online Emotional Disclosure-based Intervention During the COVID19 Pandemic (LIO-C)
Primary Purpose
COVID19
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Let It Out (LIO)-C
Neutral writing control
Sponsored by
About this trial
This is an interventional other trial for COVID19 focused on measuring COVID19, Coronavirus
Eligibility Criteria
Inclusion Criteria:
- English speaking adults over the age of 18
- Able to read and write clearly in English
Exclusion Criteria:
- None
Sites / Locations
- University College London
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LIO-C
Neutral writing control
Arm Description
Participants receive LIO-C writing intervention
Participants receive neutral writing control intervention
Outcomes
Primary Outcome Measures
Kessler Psychological Distress Scale (K10)
10-item self-report distress scale
Secondary Outcome Measures
Kessler Psychological Distress Scale (K10)
10-item self-report distress scale
Perceived Stress Scale (PSS-10)
Self-report stress scale
Pittsburgh Sleep Quality Index (PSQI)
Self-report sleep scale
Self-compassion scale (SCS)
Self-report self-compassion scale
UCLA Loneliness Scale (UCLA LS)
Self-report loneliness scale
Uptake of existing mental health services (MHS)
Self-report measure of MHS usage
Mood and meaning
3-item, 7-point, Likert scale measuring how personal and meaningful participants' felt their writing was and their mood
Acceptability
Via an online feedback form
Full Information
NCT ID
NCT04386668
First Posted
May 12, 2020
Last Updated
October 6, 2020
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT04386668
Brief Title
Let It Out (LIO) and COVID19: Testing an Online Emotional Disclosure-based Intervention During the COVID19 Pandemic
Acronym
LIO-C
Official Title
Let It Out (LIO) and COVID19: a Randomised Controlled Trial of an Online Emotional Disclosure-based Intervention for Adults During the COVID19 Pandemic
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis indicated adaptations to intervention may be required.
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
July 12, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomised controlled trial designed to test whether an online expressive writing intervention (LIO-C) can reduce distress for English-speaking adults during the global COVID19 pandemic.
Hypothesis: LIO-C will improve distress (as measured by K10) in adults at 1 week post-intervention compared to a neutral writing control during the COVID19 pandemic.
Detailed Description
The world is currently experiencing unprecedented challenges caused by the global coronavirus (COVID19) pandemic. Many countries are enforcing measures to restrict movement of people to reduce the spread of the outbreak, including lock-downs, social distancing and self-isolation. These methods, although necessary to slow the spread of disease, will have negative effects on psychological well-being of large populations. Shortage of health care professionals and measures to restrict interpersonal contact means facilitated psychological interventions will not be feasible for many, at least during the height of the pandemic. There is therefore a need for self-directed psychological interventions that can be practically and quickly implemented online.
Emotional disclosure-based therapies, such as expressive writing (EW), hold potential as low-cost, easy to implement means of support, with minimal requirement for facilitation. In its original format, EW involved writing daily for 15-20 minutes for 3-4 days about a traumatic event. Since its development, it has been adapted in many ways, including writing about positive events and writing about stress from a compassionate stance. There is evidence that such interventions can provide significant psychological and physical benefits in healthy populations and reduce the effects of natural disasters on health and well-being. However, to our knowledge this form of psychological intervention has not been tested during a rapidly evolving crisis or pandemic.
The aim of this study is to test whether an online self-compassion and EW based intervention (LIO-C) can reduce the negative effects of the COVID19 pandemic on health and well-being. The intervention is based on an existing intervention, LIO, that we previously developed for use in advanced disease populations, in collaboration with clinical and health psychologists, and patient and public representatives. For this study, we have adapted the intervention for people living through the current COVID19 pandemic by altering the writing prompts, and translating the intervention to an online hub. As this is an unfacilitated intervention, the instructions involve writing from a compassionate stance to minimise any potential short term negative effects associated with writing about difficult experiences.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19
Keywords
COVID19, Coronavirus
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LIO-C
Arm Type
Experimental
Arm Description
Participants receive LIO-C writing intervention
Arm Title
Neutral writing control
Arm Type
Placebo Comparator
Arm Description
Participants receive neutral writing control intervention
Intervention Type
Other
Intervention Name(s)
Let It Out (LIO)-C
Other Intervention Name(s)
expressive writing, emotional disclosure, expressive disclosure, therapeutic writing
Intervention Description
Participants complete three online 20-minute writing sessions in response to prompts asking them to write about their experiences during the COVID19 pandemic from a self-compassionate perspective
Intervention Type
Other
Intervention Name(s)
Neutral writing control
Intervention Description
Participants complete three online 20-minute writing sessions in response to neutral writing prompts
Primary Outcome Measure Information:
Title
Kessler Psychological Distress Scale (K10)
Description
10-item self-report distress scale
Time Frame
1 week post-intervention
Secondary Outcome Measure Information:
Title
Kessler Psychological Distress Scale (K10)
Description
10-item self-report distress scale
Time Frame
Immediately and 8 weeks post-intervention
Title
Perceived Stress Scale (PSS-10)
Description
Self-report stress scale
Time Frame
Immediately, 1 week and 8 weeks post-intervention
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Self-report sleep scale
Time Frame
Immediately, 1 week and 8 weeks post-intervention
Title
Self-compassion scale (SCS)
Description
Self-report self-compassion scale
Time Frame
Immediately, 1 week and 8 weeks post-intervention
Title
UCLA Loneliness Scale (UCLA LS)
Description
Self-report loneliness scale
Time Frame
Immediately, 1 week and 8 weeks post-intervention
Title
Uptake of existing mental health services (MHS)
Description
Self-report measure of MHS usage
Time Frame
Immediately, 1 week and 8 weeks post-intervention
Title
Mood and meaning
Description
3-item, 7-point, Likert scale measuring how personal and meaningful participants' felt their writing was and their mood
Time Frame
Immediately after each writing session
Title
Acceptability
Description
Via an online feedback form
Time Frame
Immediately post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
English speaking adults over the age of 18
Able to read and write clearly in English
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuriye Kupeli
Organizational Affiliation
Marie Curie Palliative Care Research Department, UCL
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London
City
London
State/Province
Kent
ZIP/Postal Code
TN14 6DW
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Fully anonymised participant data will be made available open access via ESRC data repository ReShare
IPD Sharing Access Criteria
Open access
Learn more about this trial
Let It Out (LIO) and COVID19: Testing an Online Emotional Disclosure-based Intervention During the COVID19 Pandemic
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