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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complementary self-help strategies in addition to treatment as usual | Experimental | 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. |
|
| Treatment as usual | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complementary self-help strategies in addition to treatment as usual | Behavioral | 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 |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Expectation | Treatment Credibility Scale (TCS): expectation about the treatment effectiveness measured from 0 = no effectiveness to 10 = highest possible effectiveness | Week 0 |
| Self-efficacy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gustav Dobos, Prof. MD | University of Duisburg-Essen | Study Chair |
| Heidemarie Haller, PhD | University of Duisburg-Essen | Principal Investigator |
| Christoph Kleinschnitz, Prof. MD | University of Duisburg-Essen | Study Director |
| Mark Stettner, Prof. MD | University of Duisburg-Essen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen | Essen | Germany |
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| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
| Treatment as usual | Other | 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. |
|
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 |
Arthritis Self-Efficacy Scale (ASES): the scale ranges from 1 to 10 with higher scores indicating more perceived efficacy
| Week 10 |
| Self-efficacy | Arthritis Self-Efficacy Scale (ASES): the scale ranges from 1 to 10 with higher scores indicating more perceived efficacy | Week 16 |
| Stress | 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 | Week 10 |
| Stress | 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 | Week 16 |
| Flourishing | 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 | Week 10 |
| Flourishing | 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 | Week 16 |
| Loneliness | 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 | Week 10 |
| Loneliness | 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 | Week 16 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |