Post-COVID-19 Syndrome
Conditions
Keywords
complementary medicine, COVID-19, post-COVID-19 Syndrome, randomized controlled trial, self-help
Brief summary
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.
Interventions
BEHAVIORALComplementary self-help strategies in addition to treatment as usual
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
OTHERTreatment 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.
Sponsors
Universität Duisburg-Essen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age of 18 years and older * Confirmed COVID-19 diagnosis by: 1. polymerase chain reaction (PCR) test or 2. 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-COVID-19 symptom burden | Week 16 | Somatic Symptom Scale-8 (SSS-8): self-report scale from 0 to 32 points with higher scores indicating higher level of burden |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | Week 10 | Chalder fatigue-scale (CFS): self-report scale from 0 - 33 points with higher scores indicating higher level of physical and mental fatigue |
| Insomnia | Week 16 | Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia |
| Cardiovascular performance | Week 10 | 6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity |
| Pulmonary performance | Week 10 | 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 |
| Post-COVID-19 functional status (physician-reported) | Week 10 | 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 |
| Adverse events | Weeks 0 - 10 | All adverse events in relation and unrelated to the intervention |
| Post-COVID-19 symptom burden | Week 10 | Somatic Symptom Scale-8 (SSS-8): self-report scale from 0 to 32 points with higher scores indicating higher level of burden |
| Post-COVID-19 functional status (self-reported) | Week 10 | 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 |
| Health-related quality of life | Week 10 | Short-form Health Survey (SF-12): self-report scale from 0 - 100 with higher score indicates a better health state |
| Anxiety and depression | Week 10 | Hospital Anxiety and Depression Scale (HADS): self-report scale form 0 - 42 with higher scores indicating higher levels of anxiety and depression |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment Expectation | Week 0 | Treatment Credibility Scale (TCS): expectation about the treatment effectiveness measured from 0 = no effectiveness to 10 = highest possible effectiveness |
| Self-efficacy | Week 10 | Arthritis Self-Efficacy Scale (ASES): the scale ranges from 1 to 10 with higher scores indicating more perceived efficacy |
| Stress | Week 10 | Perceived Stress Scale (PSS): 10-item scale, summed to create a psychological stress score of maximal 40 points with higher scores indicating greater psychological stress |
| Loneliness | Week 10 | UCLA Loneliness Scale (UCLA-LS): the short form of the UCLA-LS constsis of 12 items, ranges from 0 to 36 points, with higher higher scores indicating greater loneliness |
| Flourishing | Week 10 | Flourishing-Scale (FS): the scale ranges from 8 (lowest possible value) to 56 (highest possible value) with higher values correspond to a person with many psychological resources and strengths |
Countries
Germany
Outcome results
None listed