- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Kent
-
London, Kent, Zjednoczone Królestwo, TN14 6DW
- University College London
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- English speaking adults over the age of 18
- Able to read and write clearly in English
Exclusion Criteria:
- None
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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
Inne nazwy:
|
|
Komparator placebo: Neutral writing control
Participants receive neutral writing control intervention
|
Participants complete three online 20-minute writing sessions in response to neutral writing prompts
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Kessler Psychological Distress Scale (K10)
Ramy czasowe: 1 week post-intervention
|
10-item self-report distress scale
|
1 week post-intervention
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Kessler Psychological Distress Scale (K10)
Ramy czasowe: Immediately and 8 weeks post-intervention
|
10-item self-report distress scale
|
Immediately and 8 weeks post-intervention
|
|
Perceived Stress Scale (PSS-10)
Ramy czasowe: 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)
Ramy czasowe: Immediately, 1 week and 8 weeks post-intervention
|
Self-report sleep scale
|
Immediately, 1 week and 8 weeks post-intervention
|
|
Self-compassion scale (SCS)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Immediately post-intervention
|
Via an online feedback form
|
Immediately post-intervention
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Nuriye Kupeli, Marie Curie Palliative Care Research Department, UCL
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 15281/003
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Kryteria dostępu do udostępniania IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .