Clinical trial NCT04287296: A 12-week Feasibility Trial of a Mental Health Breakfast Show Wakey
Official title: Providing Mental Health Support Through an Educational and Entertaining Breakfast Show in the United Kingdom - a 12-week Feasibility Trial of Wakey
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Wellbeing
Keywords: mental health
mental wellbeing
wellbeing
edutainment
brekfast show
feasibility study
Lead sponsor: Method X Studios Ltd
Sponsor class: INDUSTRY
Collaborators: name: Guy's and St. Thomas' Charity
First posted: 2020-02-27
Enrollment: 3993
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A non-randomised feasibility trial with all participants receiving the intervention (the breakfast show) via app that is available for free to download on iOS and Android operating systems.
Primary purpose: PREVENTION

Brief 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.

Detailed 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!

Eligibility criteria: Inclusion Criteria:

* App users who are at least 18 years old.

Primary outcomes:
measure: Overall engagement
timeFrame: 12 weeks; collected daily (not on weekends) throughout the trial
Secondary outcomes:
measure: Change in personal well-being
timeFrame: 12 weeks; baseline, then weekly follow-ups until the end of the trial
measure: Change in the ease of getting up in the morning
timeFrame: 12 weeks; baseline, then weekly follow-ups until the end of the trial; as a daily question from Mon-Fri during the trial
measure: Change in self-efficacy
timeFrame: 12 weeks; baseline, then weekly follow-ups until the end of the trial
measure: Entertainment value of the episode
timeFrame: 12 weeks; daily question from Mon-Fri during the trial
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Method X Studios
Study officials:
References:
citation: Oeren M, Jordan I, Coughlin D, Turnbull S. Improving Access to Behavioral Strategies to Improve Mental Well-being With an Entertaining Breakfast Show App: Feasibility Evaluation Study. JMIR Form Res. 2022 Mar 23;6(3):e25715. doi: 10.2196/25715.