Let It Out (LIO) and COVID19: Testing an Online Emotional Disclosure-based Intervention During the COVID19 Pandemic

Study Overview
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Brief Summary
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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
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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.

Official Title
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Let It Out (LIO) and COVID19: a Randomised Controlled Trial of an Online Emotional Disclosure-based Intervention for Adults During the COVID19 Pandemic

Conditions
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COVID19

Intervention / Treatment
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* Other: Let It Out (LIO)-C
* Other: Neutral writing control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking adults over the age of 18 Able to read and write clearly in English Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIO-C<br>Participants receive LIO-C writing intervention | Other: Let It Out (LIO)-C<br>* 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<br>* Other names: therapeutic writing;|
| Placebo Comparator: Neutral writing control<br>Participants receive neutral writing control intervention | Other: Neutral writing control<br>* Participants complete three online 20-minute writing sessions in response to neutral writing prompts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kessler Psychological Distress Scale (K10) | 10-item self-report distress scale | 1 week post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kessler Psychological Distress Scale (K10) | 10-item self-report distress scale | Immediately and 8 weeks post-intervention | 
| Perceived Stress Scale (PSS-10) | Self-report stress scale | Immediately, 1 week and 8 weeks post-intervention | 
| Pittsburgh Sleep Quality Index (PSQI) | Self-report sleep scale | Immediately, 1 week and 8 weeks post-intervention | 
| Self-compassion scale (SCS) | Self-report self-compassion scale | Immediately, 1 week and 8 weeks post-intervention | 
| UCLA Loneliness Scale (UCLA LS) | Self-report loneliness scale | Immediately, 1 week and 8 weeks post-intervention | 
| Uptake of existing mental health services (MHS) | Self-report measure of MHS usage | Immediately, 1 week and 8 weeks post-intervention | 
| Mood and meaning | 3-item, 7-point, Likert scale measuring how personal and meaningful participants' felt their writing was and their mood | Immediately after each writing session | 
| Acceptability | Via an online feedback form | Immediately post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, Coronavirus