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

COVID19 Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04386668
• Other study ID #: 15281/003
• Status: Terminated
• Phase: N/A
• Start date: May 26, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: August 31, 2020
• Est. primary completion date: July 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English speaking adults over the age of 18

• Able to read and write clearly in English

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• COVID19

Intervention

Other:
• Let It Out (LIO)-C
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
• Neutral writing control
Participants complete three online 20-minute writing sessions in response to neutral writing prompts

Locations

Country	Name	City	State
United Kingdom	University College London	London	Kent

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kessler Psychological Distress Scale (K10)	10-item self-report distress scale	1 week post-intervention
Secondary	Kessler Psychological Distress Scale (K10)	10-item self-report distress scale	Immediately and 8 weeks post-intervention
Secondary	Perceived Stress Scale (PSS-10)	Self-report stress scale	Immediately, 1 week and 8 weeks post-intervention
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Self-report sleep scale	Immediately, 1 week and 8 weeks post-intervention
Secondary	Self-compassion scale (SCS)	Self-report self-compassion scale	Immediately, 1 week and 8 weeks post-intervention
Secondary	UCLA Loneliness Scale (UCLA LS)	Self-report loneliness scale	Immediately, 1 week and 8 weeks post-intervention
Secondary	Uptake of existing mental health services (MHS)	Self-report measure of MHS usage	Immediately, 1 week and 8 weeks post-intervention
Secondary	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
Secondary	Acceptability	Via an online feedback form	Immediately post-intervention