Monocentric Study for Development of a Smartphone Application for Patients With Depressive
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 主要终点
- Patient Health Questionnaire - for depression (PHQ-9)
研究概览
简要总结
The objective of this study is two fold, first to explore the potential of context sensitive intervention delivery to provide in-situ support for people with depressive symptoms, second to explore the detection of daily-life behavior based on smart phone sensor information to identify subjects with a clinically meaningful depression level.
详细描述
To conduct a very first pilot trial, a monocentric, single-arm clinical study is conducted. The study is approved by the local ethics committee of the Canton of Zurich in Switzerland and the Swiss Agency for Therapeutic Products. It is conducted in full accordance with the Declaration of Helsinki, with all subjects providing their electronic informed consent prior to participation. As the main interest lies in a proof of concept of the proposed MOSS app, emphasis is put on real life conditions. A range of different recruitment channels is used to attract subjects from the general public; they include physical flyers, online posts on relevant online bulletin boards and the Google Play Store.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self-declaration of depressive symptoms
- •app runs on Android 4.0 and higher
- •germen speaking
排除标准
- •psychotic symptoms
- •bipolar symptoms
- •drug or alcohol dependency
研究组 & 干预措施
Mobile Sensing
This phase of the study is designed to develop the app. due to algorithms the app should lern to detect depressive symptoms
干预措施: Mobile sensing (Device)
结局指标
主要结局
Patient Health Questionnaire - for depression (PHQ-9)
时间窗: baseline
subjective depressive symptoms to compare the detected symptoms measured by the app This outcome is needed for the sensing part of the study
次要结局
- Client Satisfaction Questionnaire (ZUF-8)- measures client satisfaction with the app(at post (at least 6 weeks after baseline) however some participants will use the app longer than 6 weeks, maximum 6 months)