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

NCT04386668 | Terminated

• 1 other identifier: 15281/003
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID19

Keywords

COVID19; Coronavirus

Outcome Measures

Primary Outcomes (1)

• Kessler Psychological Distress Scale (K10)

  10-item self-report distress scale

  1 week post-intervention

Secondary Outcomes (8)

• Kessler Psychological Distress Scale (K10)

  Immediately and 8 weeks post-intervention

• Perceived Stress Scale (PSS-10)

  Immediately, 1 week and 8 weeks post-intervention

• Pittsburgh Sleep Quality Index (PSQI)

  Immediately, 1 week and 8 weeks post-intervention

• Self-compassion scale (SCS)

  Immediately, 1 week and 8 weeks post-intervention

• UCLA Loneliness Scale (UCLA LS)

  Immediately, 1 week and 8 weeks post-intervention

Study Arms (2)

LIO-C

EXPERIMENTAL

Participants receive LIO-C writing intervention

Other: Let It Out (LIO)-C

Neutral writing control

PLACEBO COMPARATOR

Participants receive neutral writing control intervention

Other: Neutral writing control

Interventions

Let It Out (LIO)-C OTHER

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

LIO-C

Neutral writing control OTHER

Participants complete three online 20-minute writing sessions in response to neutral writing prompts

Neutral writing control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London

London, Kent, TN14 6DW, United Kingdom

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nuriye Kupeli

  Marie Curie Palliative Care Research Department, UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 13, 2020
• Study Start: May 26, 2020
• Primary Completion: July 12, 2020
• Study Completion: August 31, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Open access

Locations

GB (1)