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- Registro de ensayos clínicos de EE. UU.
- Ensayo 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kent
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London, Kent, Reino Unido, TN14 6DW
- University College London
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- English speaking adults over the age of 18
- Able to read and write clearly in English
Exclusion Criteria:
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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
Otros nombres:
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Comparador de placebos: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Kessler Psychological Distress Scale (K10)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Kessler Psychological Distress Scale (K10)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 15281/003
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Criterios de acceso compartido de IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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