Mental WellbeingNCT04287296
A 12-week Feasibility Trial of a Mental Health Breakfast Show Wakey
A study testing Wakey! in people with Mental Wellbeing, run by Method X Studios Ltd at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Wellbeing
- What is being tested?
- Wakey!
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,993 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jan 2020to 21 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- App users who are at least 18 years old.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Providing Mental Health Support Through an Educational and Entertaining Breakfast Show in the United Kingdom - a 12-week Feasibility Trial of Wakey
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.
Read the 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!
- Conditions
- Mental Wellbeing
- Being tested
- Wakey!
- Keywords
- mental health, mental wellbeing, wellbeing, edutainment, brekfast show, feasibility study
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wakey!Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| App users | Experimental | The app users who are at least 18 years old. Receives: Behavioral: Wakey! |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall engagement
Number of episodes (livestream/archived) watched over the 12-week period.
Measured: 12 weeks; collected daily (not on weekends) throughout the trial
Secondary outcomes (4)
Change in personal well-being
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).
Measured: 12 weeks; baseline, then weekly follow-ups until the end of the trial
Change in the ease of getting up in the morning
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").
Measured: 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
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.
Measured: 12 weeks; baseline, then weekly follow-ups until the end of the trial
Entertainment value of the episode
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").
Measured: 12 weeks; daily question from Mon-Fri during the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start20 Jan 2020
- Primary completion10 Apr 2020
- Study completion21 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental WellbeingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 3,993 participants (actual)
Sponsor and investigators
- Lead sponsor
- Method X Studios Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guy's and St. Thomas' Charity
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287296
- Sponsor's protocol ID
- Wakey
- Status last verified
- Feb 2021
- First submitted
- 21 Feb 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35319468
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing Mental Health Support Through an Educational and Entertaining Breakfast Show in the United Kingdom - a 12-week Feasibility Trial of Wakey
- ClinicalTrials.gov ID
- NCT04287296
- Acronym / sponsor ID
- Wakey
- Conditions
- Mental Wellbeing
- Keywords
- mental health, mental wellbeing, wellbeing, edutainment, brekfast show, feasibility study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,993 participants (actual)
- Lead sponsor
- Method X Studios LtdIndustry (pharma, biotech, devices)
- Collaborators
- Guy's and St. Thomas' Charity
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 10 Apr 2020 (actual)
- Study completion
- 21 May 2020 (actual)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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!
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| App users | Experimental | Behavioral: Wakey!The app users who are at least 18 years old. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- App users who are at least 18 years old.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wakey!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). | Behavioural | App users |
Primary outcome
Overall engagement
Time frame: 12 weeks; collected daily (not on weekends) throughout the trial
Number of episodes (livestream/archived) watched over the 12-week period.
4 secondary outcomes
Change in personal well-being
Time frame: 12 weeks; baseline, then weekly follow-ups until the end of the trial
Change in the ease of getting up in the morning
Time frame: 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
Time frame: 12 weeks; baseline, then weekly follow-ups until the end of the trial
Entertainment value of the episode
Time frame: 12 weeks; daily question from Mon-Fri during the trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Derived from this study: PubMed 35319468Oeren 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wakey! in people with Mental Wellbeing, run by Method X Studios Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall engagement (time frame: 12 weeks; collected daily (not on weekends) throughout the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04287296, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.