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

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

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.

Study Overview

• Status: Terminated
• Conditions: COVID19
• Intervention / Treatment: Other: Let It Out (LIO)-C; Other: Neutral writing control

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • London, Kent, United Kingdom, TN14 6DW
      • University College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• English speaking adults over the age of 18
• Able to read and write clearly in English

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LIO-C; Participants receive LIO-C writing 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; Other Names: expressive writing; emotional disclosure; expressive disclosure; therapeutic writing
Placebo Comparator: Neutral writing control; Participants receive neutral writing control intervention	Other: Neutral writing control; Participants complete three online 20-minute writing sessions in response to neutral writing prompts

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University College, London
• Investigators: Principal Investigator: Nuriye Kupeli, Marie Curie Palliative Care Research Department, UCL

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2020
• Primary Completion (Actual): July 12, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Coronavirus; COVID19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 15281/003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Fully anonymised participant data will be made available open access via ESRC data repository ReShare
• IPD Sharing Access Criteria: Open access

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No