Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Let It Out (LIO) and COVID19: Testing an Online Emotional Disclosure-based Intervention During the COVID19 Pandemic (LIO-C)

6 de octubre de 2020 actualizado por: University College, London

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

Terminado

Condiciones

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

Intervencionista

Inscripción (Actual)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Kent
      • London, Kent, Reino Unido, TN14 6DW
        • University College London

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Experimental: 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
Otros nombres:
  • escritura expresiva
  • emotional disclosure
  • expressive disclosure
  • therapeutic writing
Comparador de placebos: Neutral writing control
Participants receive neutral writing control intervention
Participants complete three online 20-minute writing sessions in response to neutral writing prompts

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Kessler Psychological Distress Scale (K10)
Periodo de tiempo: 1 week post-intervention
10-item self-report distress scale
1 week post-intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Kessler Psychological Distress Scale (K10)
Periodo de tiempo: Immediately and 8 weeks post-intervention
10-item self-report distress scale
Immediately and 8 weeks post-intervention
Perceived Stress Scale (PSS-10)
Periodo de tiempo: 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)
Periodo de tiempo: Immediately, 1 week and 8 weeks post-intervention
Self-report sleep scale
Immediately, 1 week and 8 weeks post-intervention
Self-compassion scale (SCS)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Immediately post-intervention
Via an online feedback form
Immediately post-intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Nuriye Kupeli, Marie Curie Palliative Care Research Department, UCL

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

26 de mayo de 2020

Finalización primaria (Actual)

12 de julio de 2020

Finalización del estudio (Actual)

31 de agosto de 2020

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2020

Primero enviado que cumplió con los criterios de control de calidad

12 de mayo de 2020

Publicado por primera vez (Actual)

13 de mayo de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de octubre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

6 de octubre de 2020

Última verificación

1 de octubre de 2020

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Fully anonymised participant data will be made available open access via ESRC data repository ReShare

Criterios de acceso compartido de IPD

Open access

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir