Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Post-COVID-19 symptom burden
研究概览
简要总结
Individuals affected by SARS-CoV-2 infection may subsequently be affected by the so-called post-COVID syndrome. The aim of the present study is to investigate the effects of a multimodal 10-week group program consisting of self-help strategies based on complementary medicine approaches of TEM (Traditional European Medicine), TCM (Traditional Chinese Medicine), and TIM (Traditional Indian Medicine) in addition to treatment as usual versus treatment as usual alone (no active study intervention/waiting list). Endpoints of the study include subjective quantitative and qualitative as well as objective (physician-reported) variables.
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
- Double (Investigator, Outcomes Assessor)
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
- •Age of 18 years and older
- •Confirmed COVID-19 diagnosis by:
- •polymerase chain reaction (PCR) test or
- •physician's letter/medical certificate/quarantine order due to ICD-10-GM U07.1 G or ICD-10-GM U09.9 G
- •Sequelae symptoms, new symptoms/disabilities, or worsening of a pre-existing medical condition that occurred in the first 3 months after confirmed SARS-CoV-2 infection and persisted for more than 2 months
- •At least 8 points (moderate symptom burden) out of a possible 32 points on the Somatic Symptom Scale-8 (SSS-8)
排除标准
- •Patients who were treated with invasive ventilation during active SARS-CoV-2 infection
- •Severe comorbid mental illness (e.g. addiction diagnosis, major depression) or other severe comorbid somatic illness (e.g. cancer without remission, severe pre-existing cardiovascular disease, insufficiency of other organs such as kidney or liver, acute febrile infection, other severe neurologic disease)
- •Pregnancy or lactation
- •Current pension application
- •Simultaneous participation in other clinical/interventional trials
研究组 & 干预措施
Complementary self-help strategies in addition to treatment as usual
The experimental group consists of 10 weeks of group treatments with educative and actively practicing elements. The patients will also receive a booklet with self-help basics and descriptions of the techniques, which should facilitate the correct practice at home. Parallel treatment as usual is allowed.
干预措施: Complementary self-help strategies in addition to treatment as usual (Behavioral)
Treatment as usual
The active control group consists a 16-week waiting period, where treatment as usual is allowed. In case of acute worsening/progression of the symptoms, consultations with the study physician are offered anytime. After the waiting period, the control group will be offered the same units as in the experimental group.
干预措施: Treatment as usual (Other)
结局指标
主要结局
Post-COVID-19 symptom burden
时间窗: Week 16
Somatic Symptom Scale-8 (SSS-8): self-report scale from 0 to 32 points with higher scores indicating higher level of burden
次要结局
- Post-COVID-19 functional status (self-reported)(Week 16)
- Fatigue(Week 16)
- Post-COVID-19 symptom burden(Week 10)
- Health-related quality of life(Week 16)
- Anxiety and depression(Week 16)
- Insomnia(Week 10)
- Cardiovascular performance(Week 16)
- Pulmonary performance(Week 16)
- Post-COVID-19 functional status (physician-reported)(Week 16)
- Adverse events(Weeks 0 - 10)
- Health-related quality of life(Week 10)
- Post-COVID-19 functional status (self-reported)(Week 10)
- Fatigue(Week 10)
- Anxiety and depression(Week 10)
- Insomnia(Week 16)
- Cardiovascular performance(Week 10)
- Pulmonary performance(Week 10)
- Post-COVID-19 functional status (physician-reported)(Week 10)
研究者
Heidemarie Haller
Principal Investigator
Universität Duisburg-Essen