COVID19LIO-CNCT04386668
Let It Out (LIO) and COVID19: Testing an Online Emotional Disclosure-based Intervention During the COVID19 Pandemic
A study testing Let It Out (LIO)-C in people with COVID19, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID19
- What is being tested?
- Let It Out (LIO)-C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 May 2020to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking adults over the age of 18
- Able to read and write clearly in English
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- COVID19
- Being tested
- Let It Out (LIO)-C, Neutral writing control
- Keywords
- COVID19, Coronavirus
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Let It Out (LIO)-COther
Also called expressive writing, emotional disclosure, expressive disclosure, therapeutic writing
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 controlOther
Participants complete three online 20-minute writing sessions in response to neutral writing prompts
| Study group | Role | What they receive |
|---|---|---|
| LIO-C | Experimental | Participants receive LIO-C writing intervention Receives: Other: Let It Out (LIO)-C |
| Neutral writing control | Placebo comparator | Participants receive neutral writing control intervention Receives: Other: Neutral writing control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kessler Psychological Distress Scale (K10)
10-item self-report distress scale
Measured: 1 week post-intervention
Secondary outcomes (8)
Kessler Psychological Distress Scale (K10)
10-item self-report distress scale
Measured: Immediately and 8 weeks post-intervention
Perceived Stress Scale (PSS-10)
Self-report stress scale
Measured: Immediately, 1 week and 8 weeks post-intervention
Pittsburgh Sleep Quality Index (PSQI)
Self-report sleep scale
Measured: Immediately, 1 week and 8 weeks post-intervention
Self-compassion scale (SCS)
Self-report self-compassion scale
Measured: Immediately, 1 week and 8 weeks post-intervention
UCLA Loneliness Scale (UCLA LS)
Self-report loneliness scale
Measured: Immediately, 1 week and 8 weeks post-intervention
Uptake of existing mental health services (MHS)
Self-report measure of MHS usage
Measured: 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
Measured: Immediately after each writing session
Acceptability
Via an online feedback form
Measured: Immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start26 May 2020
- Primary completion12 Jul 2020
- Study completion31 Aug 2020
Why it stopped: Interim analysis indicated adaptations to intervention may be required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nuriye Kupeli, Principal investigator, Marie Curie Palliative Care Research Department, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386668
- Sponsor's protocol ID
- 15281/003
- Acronym
- LIO-C
- Status last verified
- Oct 2020
- First submitted
- 12 May 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Fully anonymised participant data will be made available open access via ESRC data repository ReShare
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04386668
- Acronym / sponsor ID
- LIO-C / 15281/003
- Conditions
- COVID19
- Keywords
- COVID19, Coronavirus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis indicated adaptations to intervention may be required.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 12 Jul 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIO-C | Experimental | Other: Let It Out (LIO)-CParticipants receive LIO-C writing intervention |
| Neutral writing control | Placebo comparator | Other: Neutral writing controlParticipants receive neutral writing control intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking adults over the age of 18
- Able to read and write clearly in English
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Let It Out (LIO)-CAlso: expressive writing, emotional disclosure, expressive disclosure, therapeutic writingParticipants 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 | LIO-C |
| Neutral writing controlParticipants complete three online 20-minute writing sessions in response to neutral writing prompts | Other | Neutral writing control |
Primary outcome
Kessler Psychological Distress Scale (K10)
Time frame: 1 week post-intervention
10-item self-report distress scale
8 secondary outcomes
Kessler Psychological Distress Scale (K10)
Time frame: Immediately and 8 weeks post-intervention
Perceived Stress Scale (PSS-10)
Time frame: Immediately, 1 week and 8 weeks post-intervention
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Immediately, 1 week and 8 weeks post-intervention
Self-compassion scale (SCS)
Time frame: Immediately, 1 week and 8 weeks post-intervention
UCLA Loneliness Scale (UCLA LS)
Time frame: Immediately, 1 week and 8 weeks post-intervention
Uptake of existing mental health services (MHS)
Time frame: Immediately, 1 week and 8 weeks post-intervention
Mood and meaning
Time frame: Immediately after each writing session
Acceptability
Time frame: Immediately post-intervention
Results and safety
The study was stopped early (reason given: Interim analysis indicated adaptations to intervention may be required.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Yes. Fully anonymised participant data will be made available open access via ESRC data repository ReShare
Related trials for COVID19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuriye Kupeli principal investigator
Marie Curie Palliative Care Research Department, UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Let It Out (LIO)-C in people with COVID19, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Interim analysis indicated adaptations to intervention may be required.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kessler Psychological Distress Scale (K10) (time frame: 1 week post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.