NCT04287296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,993

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2020

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

February 21, 2020

Last Update Submit

February 22, 2021

Conditions

Keywords

mental healthmental wellbeingwellbeingedutainmentbrekfast showfeasibility study

Outcome Measures

Primary Outcomes (1)

  • Overall engagement

    Number of episodes (livestream/archived) watched over the 12-week period.

    12 weeks; collected daily (not on weekends) throughout the trial

Secondary Outcomes (4)

  • Change in personal well-being

    12 weeks; baseline, then weekly follow-ups until the end of the trial

  • Change in the ease of getting up in the morning

    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

    12 weeks; baseline, then weekly follow-ups until the end of the trial

  • Entertainment value of the episode

    12 weeks; daily question from Mon-Fri during the trial

Study Arms (1)

App users

EXPERIMENTAL

The app users who are at least 18 years old.

Behavioral: Wakey!

Interventions

Wakey!BEHAVIORAL

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).

App users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • App users who are at least 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Method X Studios

Sheffield, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 27, 2020

Study Start

January 20, 2020

Primary Completion

April 10, 2020

Study Completion

May 21, 2020

Last Updated

February 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations