Investigating the Effectiveness of Vimida, a Digital Intervention for People Suffering From Post-viral Chronic Fatigue After COVID-19 Infection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Gaia AG
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Fatigue symptom severity
研究概览
简要总结
This randomized controlled trial (RCT) with 160 patients suffering from fatigue after COVID-19 infection aims to investigate the effectiveness of the unguided digital therapeutic vimida for reducing post-COVID-19 fatigue. Inclusion criteria are: male, female or non-binary, age ≥18 years, diagnosis of post-COVID-19 fatigue, ≥3 months since the last infection with COVID-19, fatigue severity score (cut-off) of ≥ 16 on the Chalder Fatigue Scale (CFQ-11), consent to participation, and sufficient German language skills. Exclusion criteria are a known psychiatric or somatic condition that can explain the fatigue and current participation in a multidisciplinary rehabilitation program aimed to ameliorate the consequences of COVID-19.
Patients will be randomized and allocated to either an intervention group, in which they will receive access to vimida in addition to treatment as usual (TAU; n=80), or to a control group, in which they will receive access to TAU only (n=80).
The primary endpoint will be fatigue symptoms with three months post-allocation (T1) being the primary time point for assessment of effectiveness. Six months post-allocation (T2) will be used as follow-up assessment of endpoints. Secondary endpoints will be depressive symptoms, mental health-related quality of life, work/social functioning, somatic symptoms, and anxiety symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •male, female or non-binary
- •diagnosis of post-COVID-19 fatigue (ICD-10 U08.9, or U09.9 in conjunction with G93.3), secured via a telemedical visit
- •≥ 3 months since COVID-19 infection that preceded fatigue symptoms
- •elevated levels of fatigue: cut-off of ≥ 16 on the CFQ-11
- •consent to participation
- •sufficient knowledge of the German language
排除标准
- •known somatic or psychiatric condition that can explain the fatigue (e.g., cancer, multiple sclerosis, severe depression)
- •current participation in a multidisciplinary rehabilitation program aimed at ameliorating the consequences of COVID-19
研究组 & 干预措施
vimida + TAU
Participants allocated to the intervention group will receive access to vimida in addition to treatment as usual (TAU).
vimida is a digital health application designed for individuals with post-Covid conditions who suffer from fatigue, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by vimida are psychoeducation, activity and recovery, attention, stress management, sleep management, cognitive restructuring, and social resources.
The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivational text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.
干预措施: vimida (Behavioral)
TAU
Participants allocated to the control group will receive access to treatment as usual (TAU).
结局指标
主要结局
Fatigue symptom severity
时间窗: 3 months
Chalder Fatigue Scale (CFQ-11). Total score ranging from 0-33; higher scores mean higher fatigue symptoms (worse outcome).
次要结局
- Depressive symptoms(3 months)
- Health-related quality of life(3 months)
- Functioning(3 months)
- Somatic symptoms(3 months)
- Anxiety(3 months)