Life With Covid Since 2020: a Randomized Control Trial of a Real-time Data Collection Smartphone-based App Assessing and Treating the Covid-19 Psychological Impacts
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Superiority of the VieCovid2020 smartphone app
研究概览
简要总结
The COVID-19 pandemic and more specifically the confinement is an unpleasant experience for those who undergo it. Separation from loved ones, the loss of freedom, uncertainty over disease status, and boredom can, on occasion, create dramatic effects.
In fact, the pandemic and its consequences are inducing a considerable degree of fear, worry and concern in the population at large and among certain groups in particular, such as older adults, care providers and people with underlying health conditions.
If we refer back to former pandemics (SARS-CoV-1, MERS, Ebola), suicide, post-traumatic stress disorder (PTSD) and adjustment disorders have been reported, anger generated, and lawsuits brought.
The current COVID-19 pandemic is an epidemiological and psychological crisis. The enormity of living in isolation, changes in our daily lives, job loss, financial hardship and grief over the death of loved ones has the potential to affect the mental health and well-being of many.
Given the developing situation with Covid-19, policy makers urgently need evidence synthesis to produce guidance for the public and patients suffering from mental disorders such as PTSD and adjustment disorders. Therefore, it seems crucial to assess and manage the signs of anxiety, panic attacks, depression and suicide easily and at the national scale using fast, efficient and cutting-edge techniques.
Objectives :
To assess the superiority of the VieCovid2020 smartphone app, in add-on to usual care in patients suffering from PTSD or adjustment disorders within the context of COVID-19, on the rate of responders at 6 months using the PCL-5 (PTSD Checklist for DSM-5)
The VieCovid2020 smartphone application provides lifestyle and educational advices, as well as, a real-time data collection targeted the emotional state of the user.
It will be used during 3 months in add-on to usual psychiatric intervention and psychiatric evaluations.
详细描述
Design of the study :
Multicentric randomized controlled superiority trial with 2 parallel arms. The randomization will be a various-sized block randomization, stratified by centre and by co-treatment (=usual psychiatric intervention) prescribed at baseline before randomisation: selective serotonin reuptake inhibitors (SSRI) alone or SSRI in combination to eye movement desensitization and reprocessing (EMDR), cognitive behavioural therapy (CBT) or reconsolidation blockade.
Objectives :
To assess the superiority of the VieCovid2020 smartphone app, in add-on to usual care in patients suffering from PTSD or adjustment disorders within the context of COVID-19, on the rate of responders at 6 months using the PCL-5 (PTSD Checklist for DSM-5)
Every patient will be randomized between:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Superiority of the VieCovid2020 smartphone app
时间窗: 6 MONTHS
To assess the superiority of the VieCovid2020 smartphone app, in add-on to usual care in patients suffering from adjustments disorders or PTSD within the context of COVID-19, on the rate of responders at 6 months on the PCL-5.
次要结局
- User adherence of the VieCovid app(3 months)
- Impact of co-treatments(3 months)
- Economic Impact(6 months)