Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04287296 |
| Other study ID # |
Wakey |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 20, 2020 |
| Est. completion date |
May 21, 2020 |
Study information
| Verified date |
February 2021 |
| Source |
Method X Studios Ltd |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of Wakey! is to increase access to wellbeing support to lower socio-economic groups
who have traditionally been excluded from the design and evaluation of digital mental health
interventions. This feasibility study is designed to explore engagement, initial efficacy and
experience of using Wakey! in the underserved populations in the United Kingdom. This will be
used to further adapt and refine the intervention, so it is appealing and effective in the
target populations.
Description:
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!
