- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04386668
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Kent
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London, Kent, Det Forenede Kongerige, TN14 6DW
- University College London
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- English speaking adults over the age of 18
- Able to read and write clearly in English
Exclusion Criteria:
- None
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: LIO-C
Participants receive LIO-C writing intervention
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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
Andre navne:
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Placebo komparator: Neutral writing control
Participants receive neutral writing control intervention
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Participants complete three online 20-minute writing sessions in response to neutral writing prompts
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Kessler Psychological Distress Scale (K10)
Tidsramme: 1 week post-intervention
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10-item self-report distress scale
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1 week post-intervention
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Kessler Psychological Distress Scale (K10)
Tidsramme: Immediately and 8 weeks post-intervention
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10-item self-report distress scale
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Immediately and 8 weeks post-intervention
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Perceived Stress Scale (PSS-10)
Tidsramme: Immediately, 1 week and 8 weeks post-intervention
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Self-report stress scale
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Immediately, 1 week and 8 weeks post-intervention
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Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: Immediately, 1 week and 8 weeks post-intervention
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Self-report sleep scale
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Immediately, 1 week and 8 weeks post-intervention
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Self-compassion scale (SCS)
Tidsramme: Immediately, 1 week and 8 weeks post-intervention
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Self-report self-compassion scale
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Immediately, 1 week and 8 weeks post-intervention
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UCLA Loneliness Scale (UCLA LS)
Tidsramme: Immediately, 1 week and 8 weeks post-intervention
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Self-report loneliness scale
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Immediately, 1 week and 8 weeks post-intervention
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Uptake of existing mental health services (MHS)
Tidsramme: Immediately, 1 week and 8 weeks post-intervention
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Self-report measure of MHS usage
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Immediately, 1 week and 8 weeks post-intervention
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Mood and meaning
Tidsramme: Immediately after each writing session
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3-item, 7-point, Likert scale measuring how personal and meaningful participants' felt their writing was and their mood
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Immediately after each writing session
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Acceptability
Tidsramme: Immediately post-intervention
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Via an online feedback form
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Immediately post-intervention
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Nuriye Kupeli, Marie Curie Palliative Care Research Department, UCL
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15281/003
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingsadgangskriterier
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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