- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
Kent
-
London, Kent, Spojené království, TN14 6DW
- University College London
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- English speaking adults over the age of 18
- Able to read and write clearly in English
Exclusion Criteria:
- None
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: LIO-C
Participants receive LIO-C writing intervention
|
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
Ostatní jména:
|
|
Komparátor placeba: Neutral writing control
Participants receive neutral writing control intervention
|
Participants complete three online 20-minute writing sessions in response to neutral writing prompts
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Kessler Psychological Distress Scale (K10)
Časové okno: 1 week post-intervention
|
10-item self-report distress scale
|
1 week post-intervention
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Kessler Psychological Distress Scale (K10)
Časové okno: Immediately and 8 weeks post-intervention
|
10-item self-report distress scale
|
Immediately and 8 weeks post-intervention
|
|
Perceived Stress Scale (PSS-10)
Časové okno: Immediately, 1 week and 8 weeks post-intervention
|
Self-report stress scale
|
Immediately, 1 week and 8 weeks post-intervention
|
|
Pittsburgh Sleep Quality Index (PSQI)
Časové okno: Immediately, 1 week and 8 weeks post-intervention
|
Self-report sleep scale
|
Immediately, 1 week and 8 weeks post-intervention
|
|
Self-compassion scale (SCS)
Časové okno: Immediately, 1 week and 8 weeks post-intervention
|
Self-report self-compassion scale
|
Immediately, 1 week and 8 weeks post-intervention
|
|
UCLA Loneliness Scale (UCLA LS)
Časové okno: Immediately, 1 week and 8 weeks post-intervention
|
Self-report loneliness scale
|
Immediately, 1 week and 8 weeks post-intervention
|
|
Uptake of existing mental health services (MHS)
Časové okno: Immediately, 1 week and 8 weeks post-intervention
|
Self-report measure of MHS usage
|
Immediately, 1 week and 8 weeks post-intervention
|
|
Mood and meaning
Časové okno: Immediately after each writing session
|
3-item, 7-point, Likert scale measuring how personal and meaningful participants' felt their writing was and their mood
|
Immediately after each writing session
|
|
Acceptability
Časové okno: Immediately post-intervention
|
Via an online feedback form
|
Immediately post-intervention
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Nuriye Kupeli, Marie Curie Palliative Care Research Department, UCL
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 15281/003
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Kritéria přístupu pro sdílení IPD
Informace o lécích a zařízeních, studijní dokumenty
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