- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04287296
A 12-week Feasibility Trial of a Mental Health Breakfast Show Wakey
Providing Mental Health Support Through an Educational and Entertaining Breakfast Show in the United Kingdom - a 12-week Feasibility Trial of Wakey
Descripción general del estudio
Descripción detallada
Mental health conditions are a considerable burden for patients and health services and have been shown to have social patterning in severity and incidence. Children and adults living in the lowest 20% income bracket are two to three times more likely to develop a mental health condition than those people living in the top 20% bracket. Unemployment, working in jobs with low pay and insecure work have been found to be detrimental to mental health. Mental health services are struggling to cope with demands on services, and unequal access to support is further exacerbating health inequalities.
Digital interventions have been proposed as a solution to address the high demand for mental health support in the context of the crisis in healthcare services. These interventions provide the potential to reduce health disparities, by providing personalised low-cost infinitely reusable resource that can increase access to health interventions. However, these interventions may increase inequity, where access and usability for disadvantaged groups remain barriers. To ensure health inequalities are not further exacerbated, there is a need to develop digital interventions that are appealing and accessible those from lower socioeconomic groups. These are social groups that currently look to entertainment to regulate difficult emotions and for education.
An initial pilot of the 9-minute show was trialled in the United Kingdom with a lower socio-economic group and was well received. The app was advertised through the companies that partner with Lost In TV Audience Services, who has a database of 450,000 people. In the initial pilot 43,000 people opened the email about the app. The live morning breakfast show that ran for two weeks was used by 450 participants. The findings were that 50% watched all 10 shows, 65% said that would download the app "today", 70% said it was easier to get out of bed, 53% saw an increase in life satisfaction, and 67% reported an increase in self-efficacy.
The primary objectives of the feasibility study are:
- To assess how many people download the app in the target population
- To assess participant's engagement with the app over the 12-week trial period
The secondary objectives are:
- To explore efficacy data on Office for National Statistics well-being outcomes, sleep and self-efficacy outcomes and to see if there are any changes throughout the trial
- To explore, quantitatively and qualitatively, participants' experiences of using Wakey!
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Sheffield, Reino Unido
- Method X Studios
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- App users who are at least 18 years old.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: App users
The app users who are at least 18 years old.
|
Everyone who has downloaded the app will receive a 9-minute morning show as an alternative to an alarm clock every Mon-Fri for 12 weeks.
The show is presented by a cast of presenters who appeal to the target demographic.
The intervention content is theory and evidence led, drawing on approaches from cognitive and third-wave psychotherapies, positive psychology interventions (such as those based on resilience training and growth mindset), and lifestyle mental health interventions.
Additional content will be provided on the app to support the theory and techniques that are covered in the show.
Fun content will also be posted in an ad-hoc manner that complement the shows or relate to cultural dates and aim to increase engagement.
Wakey! will avoid any polarising topics such as politics, religion and folk science.
There are several features beside the show itself: a moderated live chat between 6-9AM, feedback for users (e.g.
how many days they have seen the show, current energy levels).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall engagement
Periodo de tiempo: 12 weeks; collected daily (not on weekends) throughout the trial
|
Number of episodes (livestream/archived) watched over the 12-week period.
|
12 weeks; collected daily (not on weekends) throughout the trial
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in personal well-being
Periodo de tiempo: 12 weeks; baseline, then weekly follow-ups until the end of the trial
|
UK's national personal well-being measures (used in the Annual Population Survey) about life satisfaction, feeling the things done in life are worthwhile, happiness and anxiety.
The participants are asked to rate the four domains on a scale of 0 ("not at all") to 10 ("completely").
Higher scores indicate higher perception of wellbeing (except for anxiety, where higher scores indicate higher level of anxiety).
|
12 weeks; baseline, then weekly follow-ups until the end of the trial
|
|
Change in the ease of getting up in the morning
Periodo de tiempo: 12 weeks; baseline, then weekly follow-ups until the end of the trial; as a daily question from Mon-Fri during the trial
|
The participants are asked to rate how easy it was to get up this morning on a scale of 0 ("not at all") to 10 ("completely").
|
12 weeks; baseline, then weekly follow-ups until the end of the trial; as a daily question from Mon-Fri during the trial
|
|
Change in self-efficacy
Periodo de tiempo: 12 weeks; baseline, then weekly follow-ups until the end of the trial
|
The participants are asked to assess to what extent they agree with the statement "I can successfully overcome life's daily challenges".
The answers include: strongly agree (1), agree (2), neither agree or disagree (3), disagree (4), strongly disagree (5).
Higher scores indicate lower self-efficacy.
|
12 weeks; baseline, then weekly follow-ups until the end of the trial
|
|
Entertainment value of the episode
Periodo de tiempo: 12 weeks; daily question from Mon-Fri during the trial
|
The participants are asked to rate how entertaining did they find the current episode on a scale of 0 ("not at all") to 10 ("completely").
|
12 weeks; daily question from Mon-Fri during the trial
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
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
Otros números de identificación del estudio
- Wakey
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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.
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. .
Ensayos clínicos sobre Bienestar mental
-
Chinese University of Hong KongReclutamientoSalud Mental Bienestar 1 | Bienestar mental | Problema de salud mental | Salud mental de precisiónHong Kong
-
Neslihan LokTerminadoAdolescente | Salud mental | Cuidado de la salud mental | Condiciones de salud mentalPavo
-
Sword Health, SAInscripción por invitaciónResiliencia mental | Angustia mentalEstados Unidos
-
Sanctuary Mental Health MinistriesExcellence in Giving InsightsAún no reclutandoSalud mental | Búsqueda de ayuda de salud mental | Alfabetización en salud mentalEstados Unidos
-
Chinese University of Hong KongTerminadoBienestar mental | Alfabetización en salud mentalHong Kong
-
King's College LondonTerminadoSalud Mental Bienestar 1 | Problema de salud mentalReino Unido
-
Chinese University of Hong KongTerminadoSalud Mental Bienestar 1 | Bienestar mental | Problema de salud mentalHong Kong
-
Chinese University of Hong KongThe University of Hong Kong; The Hong Kong Polytechnic University; The Hong Kong... y otros colaboradoresReclutamientoBienestar mental | Salud Adolescente | Búsqueda de ayuda de salud mental | Alfabetización en salud mental | Dificultades escolares asociadas a problemas de salud mentalHong Kong
-
Assiut UniversityAún no reclutandoSalud mental | Comportamiento de búsqueda de ayuda | Alfabetización en salud mental | Estigma de la enfermedad mental | Salud mental adolescente
-
Norwegian Institute of Public HealthTerminadoSalud Mental Bienestar 1 | Estrés mental | Depresión mentalNoruega