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

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ClinicalTrials.gov Identifier: NCT04386668
Recruitment Status : Terminated (Interim analysis indicated adaptations to intervention may be required.)
First Posted : May 13, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
University College, London

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.


Condition or disease Intervention/treatment Phase
COVID19 Other: Let It Out (LIO)-C Other: Neutral writing control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : May 26, 2020
Actual Primary Completion Date : July 12, 2020
Actual Study Completion Date : August 31, 2020

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




Primary Outcome Measures :
  1. Kessler Psychological Distress Scale (K10) [ Time Frame: 1 week post-intervention ]
    10-item self-report distress scale


Secondary Outcome Measures :
  1. Kessler Psychological Distress Scale (K10) [ Time Frame: Immediately and 8 weeks post-intervention ]
    10-item self-report distress scale

  2. Perceived Stress Scale (PSS-10) [ Time Frame: Immediately, 1 week and 8 weeks post-intervention ]
    Self-report stress scale

  3. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Immediately, 1 week and 8 weeks post-intervention ]
    Self-report sleep scale

  4. Self-compassion scale (SCS) [ Time Frame: Immediately, 1 week and 8 weeks post-intervention ]
    Self-report self-compassion scale

  5. UCLA Loneliness Scale (UCLA LS) [ Time Frame: Immediately, 1 week and 8 weeks post-intervention ]
    Self-report loneliness scale

  6. Uptake of existing mental health services (MHS) [ Time Frame: Immediately, 1 week and 8 weeks post-intervention ]
    Self-report measure of MHS usage

  7. Mood and meaning [ Time Frame: Immediately after each writing session ]
    3-item, 7-point, Likert scale measuring how personal and meaningful participants' felt their writing was and their mood

  8. Acceptability [ Time Frame: Immediately post-intervention ]
    Via an online feedback form



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386668


Locations
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United Kingdom
University College London
London, Kent, United Kingdom, TN14 6DW
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Nuriye Kupeli Marie Curie Palliative Care Research Department, UCL
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT04386668    
Other Study ID Numbers: 15281/003
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Fully anonymised participant data will be made available open access via ESRC data repository ReShare
Access Criteria: Open access

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University College, London:
COVID19
Coronavirus