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A 12-week Feasibility Trial of a Mental Health Breakfast Show Wakey

2021年2月22日 更新者:Method X Studios Ltd

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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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!

研究类型

介入性

注册 (实际的)

3993

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Sheffield、英国
        • Method X Studios

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • App users who are at least 18 years old.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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).

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Overall engagement
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Change in personal well-being
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年1月20日

初级完成 (实际的)

2020年4月10日

研究完成 (实际的)

2020年5月21日

研究注册日期

首次提交

2020年2月21日

首先提交符合 QC 标准的

2020年2月26日

首次发布 (实际的)

2020年2月27日

研究记录更新

最后更新发布 (实际的)

2021年2月23日

上次提交的符合 QC 标准的更新

2021年2月22日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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