An interventional study of Let It Out (LIO)-C and Neutral writing control in COVID19, sponsored by University College, London. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by University College, London · Not applicable, Interventional, and Other
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 80 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive LIO-C writing intervention
Other: Let It Out (LIO)-C
Participants receive neutral writing control intervention
Other: Neutral writing control
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
Also known as: expressive writing, emotional disclosure, expressive disclosure, therapeutic writing
Participants complete three online 20-minute writing sessions in response to neutral writing prompts
Kessler Psychological Distress Scale (K10)
10-item self-report distress scale
Time frame: 1 week post-intervention
Kessler Psychological Distress Scale (K10)
10-item self-report distress scale
Time frame: Immediately and 8 weeks post-intervention
Perceived Stress Scale (PSS-10)
Self-report stress scale
Time frame: Immediately, 1 week and 8 weeks post-intervention
Pittsburgh Sleep Quality Index (PSQI)
Self-report sleep scale
Time frame: Immediately, 1 week and 8 weeks post-intervention
Self-compassion scale (SCS)
Self-report self-compassion scale
Time frame: Immediately, 1 week and 8 weeks post-intervention
UCLA Loneliness Scale (UCLA LS)
Self-report loneliness scale
Time frame: Immediately, 1 week and 8 weeks post-intervention
Uptake of existing mental health services (MHS)
Self-report measure of MHS usage
Time frame: 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
Time frame: Immediately after each writing session
Acceptability
Via an online feedback form
Time frame: Immediately post-intervention
Plan to share: Yes — Fully anonymised participant data will be made available open access via ESRC data repository ReShare
No publications or documents are linked to this record.
This study is terminated, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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University College, London