Can mental health apps work in the real world? A feasibility pilot study

描述（由申请人提供）：美国有超过200万人将健康应用程序下载到他们的智能手机和平板电脑上，目的是提高他们的生活质量。尽管这些应用程序被广泛使用，但有关应用程序用户访问（用户是否下载健康应用程序并多次使用它们）、应用程序用户参与度（用户是否遵守应用程序协议）以及应用程序对情绪、认知和日常功能的影响的信息相对较少。我们的长期目标是开展一项未来随机对照试验，调查两种类型的心理健康应用程序的使用、参与和影响，一种是基于循证治疗原则的应用程序（即：问题解决疗法），另一种是基于抑郁症认知神经科学原则的应用程序(即：我们的目的是完全在移动设备上进行这项研究，以便以一种生态有效的方式调查访问、参与度和影响。本初步研究的目的是测试我们未来进行随机对照试验的可行性，比较三种移动心理健康应用程序对18岁及以上人群抑郁情绪的管理、认知控制的改善和日常生活活动的改善。招募、同意、随机化、应用程序使用和结果评估将完全在移动设备上进行。我们将通过四种不同的招募途径招募150人，以确定哪种途径在我们的目标人群（18岁及以上有抑郁症症状并影响其生活质量的人）中最具代表性的样本。我们还将确定需要招募的人数，以获得150人的最终样本，他们愿意随机分配到这三款应用中，完成一项为期12周的研究，研究应用对情绪、认知和功能的影响。该试点将提供以这种方式进行的研究数据的完整性信息，并揭示我们在使用移动设备收集数据时可能面临的任何其他挑战，以及我们是否会发现应用类型之间的差异退出（例如：是否会有更多的人过早地停止使用仅提供信息的应用程序？）虽然我们没有足够的统计能力来回答有关应用程序之间比较有效性的问题，但我们计划探索样本人口统计学、应用程序使用和认知控制改善对情绪和功能的改善之间的关系。

DESCRIPTION (provided by applicant): Over two million people in the US download health apps onto their smartphones and tablets, with the intent of improving their quality of life. Despit widespread use of these apps, there is relatively little information regarding app user access (do users download health apps and use them more than once), app user engagement (do users follow the app protocols) and app impact on mood, cognition and daily functioning. Our long-term goal is to conduct a future randomized controlled trial investigating access, engagement and impact of two types of mental health apps, apps based on evidence-based therapeutic principles (i.e.: Problem Solving Therapy) and apps based on cognitive neuroscience principles of depression (i.e.: a cognitive training game called Evolution) and compare both to an information only app. Our intent is to conduct this study entirely on mobile devices, in order to investigate access, engagement, and impact in an ecologically valid manner. The purpose of this pilot study is to test the feasibility of conducting our future randomized controlled trial comparing three mobile mental health apps for the management of depressed mood, improvement of cognitive control, and improvement in activities of daily living in people aged 18 and older. Recruitment, consent, randomization, app use and outcome assessment will be conducted entirely on mobile devices. We will recruit 150 people through four different recruitment avenues to determine which avenue results in the most representative sample of our target population (people 18 and older who have symptoms of depression that are interfering with their quality of life). We will also determine the number we need to recruit to have a final sample of 150 people willing to be randomized between the 3 apps and complete an 12-week study of app impact on mood, cognition and function. This pilot will provide information on the completeness of data from a study conducted in this manner, and uncover any other challenges we may face by using mobile devices for data collection, and if we will find differential drop out between app type (e.g.: will more people stop using of the information only app prematurely?). Although we will not have sufficient statistical power to answer questions about comparative effectiveness between the apps, we plan to explore relationships between sample demographics, app use, and improvement in cognitive control on improvements in mood and function.