Clinical trial NCT04386668: Let It Out (LIO) and COVID19: Testing an Online Emotional Disclosure-based Intervention During the COVID19 Pandemic
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
Overall status: TERMINATED
Phase: NA
Conditions: COVID19
Keywords: COVID19
Coronavirus
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Kessler Psychological Distress Scale (K10)
timeFrame: 1 week post-intervention
Secondary outcomes:
measure: Kessler Psychological Distress Scale (K10)
timeFrame: Immediately and 8 weeks post-intervention
measure: Perceived Stress Scale (PSS-10)
timeFrame: Immediately, 1 week and 8 weeks post-intervention
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Immediately, 1 week and 8 weeks post-intervention
measure: Self-compassion scale (SCS)
timeFrame: Immediately, 1 week and 8 weeks post-intervention
measure: UCLA Loneliness Scale (UCLA LS)
timeFrame: Immediately, 1 week and 8 weeks post-intervention
measure: Uptake of existing mental health services (MHS)
timeFrame: Immediately, 1 week and 8 weeks post-intervention
measure: Mood and meaning
timeFrame: Immediately after each writing session
measure: Acceptability
timeFrame: Immediately post-intervention
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
state: Kent
Study officials:
affiliation: Marie Curie Palliative Care Research Department, UCL
name: Nuriye Kupeli
role: PRINCIPAL_INVESTIGATOR
References: