Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome After COVID-19

Study Overview
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Brief Summary
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The Post-COVID syndrome is a COVID-19 sequelae disease with high individual burden. We conduct a prospective, two-arm, randomized-controlled intervention study with embedded qualitative and physiological sub-studies in a mixed-methods design.

Official Title
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Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome - a Randomized-controlled Mixed-methods Trial.

Conditions
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Post-COVID Syndrome

Intervention / Treatment
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* Behavioral: Complementary and Integrative Medicine online intervention, routine care and book
* Behavioral: Routine care and book


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Acute SARS-CoV2 infection at least 12 weeks ago (documented by PCR test results or SARS-CoV-2 antibodies) History of chronic fatigue (after SARS-CoV-2 infection) At least 3 of 7 criteria fulfilled at the time of inclusion: sleep disturbance, headache, joint pain/muscle pain, anxiety/depression, memory impairment/concentration disturbance, postexertional malaise, dysosmia/anosmia Numerical Rating Scale (NRS, 0-10 points, 0 = not able to exercise at all; 10 = full exercise capacity) physical exercise capacity of max. 6 points (What is your physical exercise capacity on average over the last 7 days?) Short Form-36 Physical Function Subscale (SF-36 PFS) of maximum 65 points Patient are technically equipped enough to participate in the online intervention and willing to follow the study procedure to perform the online intervention at home Exclusion criteria: Fatigue already present before SARS-CoV-2 infection Presence of severe post-exertional malaise (PEM) (according to DSQ-PEM tool question 7 OR 8 with yes AND >14h condition worsening) Other underlying conditions leading to symptoms of chronic fatigue, such as unstable mental illness, oncological disease(s), MS, fibromyalgia, and substance abuse Other serious underlying medical conditions, such as severe pulmonary, cardiac, psychiatric, or infectious diseases that could interfere with study participation or affect results • Ongoing opioid therapy or opioid therapy in the week prior to study entry Regular use of cannabinoids or other illicit drugs in the month prior to or during the study Restarting or discontinuing psychotherapy during study participation in the 6 weeks prior to study entry Pregnancy or breastfeeding Participation in another clinical intervention study during study participation 1 Regular use of Complementary and Integrative Medicine self-help measures (e.g. meditation, Kneipp hydrotherapiy, etc.) within the study period Current pension procedure or planned claiming of a pension procedure due to disability Planned rehabilitation measures during study participation due to post-COVID syndrome Inclusion and exclusion criteria of the sub-study focus group interviews with physicians Inclusion criteria: Family physicians and general practitioners Regular outpatient care of patients with post-covid syndrome Willingness in principle to participate in a 2-hour interview on-site or online Exclusion criteria: • No previous care of post-covid patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complementary and Integrative Medicine online intervention, routine care and book<br> | Behavioral: Complementary and Integrative Medicine online intervention, routine care and book<br>* The online program takes place in a multiprofessionally guided online group setting once a week for up to 180 minutes (including several breaks) over a period of 10 weeks: Basic principles of a plant-based whole-food nutrition Procedures of hydrotherapy according to Kneipp Self-help strategies (e.g. teas, wraps, compresses etc.) Methods of mind-body medicine (mindfulness, meditation, breathing, yoga etc.) Methods of extended Complementary and Integrative Medicine (e.g. acupressure) It is recommended to practice a part of the taught exercises at home for about 30 minutes daily. In addition, the patients receive a book for the treatment of post-covid syndrome complaints. Group 1 additionally uses the already existing routine care (e.g. general practitioner).<br>|
| Active Comparator: Routine care and book<br> | Behavioral: Routine care and book<br>* Participants in the second study arm receive routine care, e.g. from their general practitioner. In addition, the patients receive the same book as group 1 for the treatment of post-covid syndrome complaints. The participants of the second study arm will be offered to participate in the Complementary and Integrative Medicine online intervention after 4 months within the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 36 (SF-36), Physical Functioning Scale | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form 36 (SF-36) | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM) | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| Post-COVID-Syndrom (PCS) Score | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| Chalder Fatigue Scale (CFS) | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| Quality of life (EQ-5D-5L) | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| General Self-Efficacy Scale (GSE, German version: ASKU) | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| Visual analog scale (VAS) physical strength | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| Visual analog scale (VAS) mental strength | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| Visual analog scale (VAS) headache | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| Patient Health Questionnaire 9 (PHQ9) | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| Pittsburgh Sleep Quality Index (PSQI) | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| Lifestyle questions (diet, alcohol, cigarettes, relaxation, hydrotherapie, nature stays, physical activity) |  | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| Expectation regarding study intervention | 5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level. | Baseline | 
| Perceived Stress Scale (PSS 4) | The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| Satisfaction with the intervention | 5-point likert-scale. The scale ranges from 0 to 5, where 0 is the lowest level and 5 is the highest level. | Week 10 | 
| Safety by recording adverse events |  | Baseline, 10 weeks, 4 months, 6 months, 12 months | 
| Adherence to the study intervention | Asking Minutes (min.) of the last week | Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10 | 
| Online diaries for assessing routine care (GP prescriptions/measures, especially medication and phytotherapy/nutritional supplements) |  | Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, 4 months, 6 months, 12 months | 
| Continuation of the intervention | Asking Minutes (min.) of the last month | 4 months, 6 months, 12 months |