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- Ensaio Clínico 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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Kent
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London, Kent, Reino Unido, TN14 6DW
- University College London
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- English speaking adults over the age of 18
- Able to read and write clearly in English
Exclusion Criteria:
- None
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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
Outros nomes:
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Comparador de Placebo: 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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Kessler Psychological Distress Scale (K10)
Prazo: 1 week post-intervention
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10-item self-report distress scale
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1 week post-intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Kessler Psychological Distress Scale (K10)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: Immediately post-intervention
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Via an online feedback form
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Immediately post-intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Nuriye Kupeli, Marie Curie Palliative Care Research Department, UCL
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 15281/003
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
Critérios de acesso de compartilhamento IPD
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