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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
86
The 10-week group program consists of self-help strategies from complementary medicine approaches of TEM (Traditional European Medicine), TCM (Traditional Chinese Medicine), and TIM (Traditional Indian Medicine) in addition to 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.
Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
Essen, Germany
Post-COVID-19 symptom burden
Somatic Symptom Scale-8 (SSS-8): self-report scale from 0 to 32 points with higher scores indicating higher level of burden
Time frame: Week 16
Post-COVID-19 symptom burden
Somatic Symptom Scale-8 (SSS-8): self-report scale from 0 to 32 points with higher scores indicating higher level of burden
Time frame: Week 10
Post-COVID-19 functional status (self-reported)
Post-COVID-19 Functional Status Scale - Patient Version (PCFS): self-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Time frame: Week 10
Post-COVID-19 functional status (self-reported)
Post-COVID-19 Functional Status Scale - Patient Version (PCFS): self-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Time frame: Week 16
Health-related quality of life
Short-form Health Survey (SF-12): self-report scale from 0 - 100 with higher score indicates a better health state
Time frame: Week 10
Health-related quality of life
Short-form Health Survey (SF-12): self-report scale from 0 - 100 with higher score indicates a better health state
Time frame: Week 16
Fatigue
Chalder fatigue-scale (CFS): self-report scale from 0 - 33 points with higher scores indicating higher level of physical and mental fatigue
Time frame: Week 10
Fatigue
Chalder fatigue-scale (CFS): self-report scale from 0 - 33 points with higher scores indicating higher level of physical and mental fatigue
Time frame: Week 16
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS): self-report scale form 0 - 42 with higher scores indicating higher levels of anxiety and depression
Time frame: Week 10
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS): self-report scale form 0 - 42 with higher scores indicating higher level of anxiety and depression
Time frame: Week 16
Insomnia
Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia
Time frame: Week 16
Insomnia
Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia
Time frame: Week 10
Cardiovascular performance
6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity
Time frame: Week 10
Cardiovascular performance
6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity
Time frame: Week 16
Pulmonary performance
Borg Breathlessness Scale (Borg-CR10-Scale): scale from 0-10 with higher scores indicating higher breathlessness/dyspnea - assesed subsequent to the 6-Minute-Walking-Test
Time frame: Week 10
Pulmonary performance
Borg Breathlessness Scale (Borg-CR10-Scale): scale from 0-10 with higher scores indicating higher breathlessness/dyspnea - assesed subsequent to the 6-Minute-Walking-Test
Time frame: Week 16
Post-COVID-19 functional status (physician-reported)
Post-COVID-19 Functional Status Scale - Physician Version (PCFS): physician-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Time frame: Week 10
Post-COVID-19 functional status (physician-reported)
Post-COVID-19 Functional Status Scale - Physician Version (PCFS): physician-report scale from 0 - 4 points with 0 = no functional limitations and 4 = severe functional limitations
Time frame: Week 16
Adverse events
All adverse events in relation and unrelated to the intervention
Time frame: Weeks 0 - 10
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.