Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome: A Randomized Controlled Trial

Conditions
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Post-COVID-19 Syndrome

Intervention / Treatment
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* Behavioral: Complementary self-help strategies in addition to treatment as usual
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complementary self-help strategies in addition to treatment as usual<br>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. | Behavioral: Complementary self-help strategies in addition to treatment as usual<br>* 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<br>|
| Active Comparator: Treatment as usual<br>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. | Other: Treatment as usual<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Week 16 | 
| Insomnia | Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia | Week 16 | 
| Insomnia | Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia | Week 10 | 
| Cardiovascular performance | 6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity | Week 10 | 
| Cardiovascular performance | 6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity | 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 | 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 | 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 | 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 | Week 16 | 
| Adverse events | All adverse events in relation and unrelated to the intervention | Weeks 0 - 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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complementary medicine, COVID-19, post-COVID-19 Syndrome, randomized controlled trial, self-help