You Are Not Alone: a Mobile Application to Reduce Psychosocial Stress
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in subjective depression symptoms severity
研究概览
简要总结
The purpose of this research study is to test the efectivness of the remote solution for psychosocial stress in pregnant women and postpartum women. Based on the connection of know-how in the field of social sciences and humanities (psychology, volunteer community and peer work with target group) and technological know-how (software design and development), investigators developed an interactive intervention software (Kogito app) to reduce psychosocial stress in the target group.
详细描述
This study examine the potential of Kogito app in the delivery of mental and social support care to pregnant and postpartum women using psychometric methods.
A) Clinical efficacy of Kogito app in a clinical cohort. Sample: pregnant or postpartum women with who are being treated in the psychiatric perinatal outpatient clinic of the National Institute of Mental Health, Czech Republic. The app will be tested as a add-on method of care.
Intervention group: Kogito app is added to the usual care Control group: usual care Randomization: 1:1
Participants in the intervention group will be asked to do following things:
- complete survey questions at entrance into the study
- use the kogito app
- complete survey questions one month after study entrance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age 18 or older
- •pregnant women to 1 year after childbirth
- •speak, read, and understand Czech
- •signing of informed consent to the study and the GDPR form
- •participant owns a smart phone and has access to the internet access plus for the clinical group:
- •participant is undergoing the usual psychiatric care of the perinatal outpatient clinic of the National Institute of Mental Health, Czechia.
排除标准
- 未提供
结局指标
主要结局
Change in subjective depression symptoms severity
时间窗: Baseline to 1 month after study enrollment
measured by the Edinburgh Perinatal Depression Scale
次要结局
- Change in subjective anxiety symptoms severity(Baseline to 1 month after study enrollment)
- Change in subjective loneliness severity(Baseline to 1 month after study enrollment)
- Change in subjective health related quality of life(Baseline to 1 month after study enrollment)