Post-COVID SyndromeNCT06004362
Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome After COVID-19
A study testing Complementary and Integrative Medicine online intervention, routine care and book and Routine care and book in people with Post-COVID Syndrome, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post-COVID Syndrome
- What is being tested?
- Complementary and Integrative Medicine online intervention, routine care and book and Routine care and book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 4 Sep 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- No previous care of post-covid patients
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, 14109
Miriam Rösner, Study nurse, 00493080505682, naturheilkunde.studien@immanuel.de
Andreas Michalsen, Prof. Dr.
About this study
Official title: Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome - a Randomized-controlled Mixed-methods Trial.
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.
- Conditions
- Post-COVID Syndrome
- Being tested
- Complementary and Integrative Medicine online intervention, routine care and book, Routine care and book
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complementary and Integrative Medicine online intervention, routine care and bookBehavioural
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).
Routine care and bookBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Complementary and Integrative Medicine online intervention, routine care and book | Experimental | Not described Receives: Behavioral: Complementary and Integrative Medicine online intervention, routine care and book |
| Routine care and book | Active comparator | Not described Receives: Behavioral: Routine care and book |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 10 weeks
Secondary outcomes (19)
Short Form 36 (SF-36)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
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.
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Post-COVID-Syndrom (PCS) Score
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Chalder Fatigue Scale (CFS)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
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.
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
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.
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
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.
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
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.
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Visual analog scale (VAS) headache
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Patient Health Questionnaire 9 (PHQ9)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Pittsburgh Sleep Quality Index (PSQI)
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Lifestyle questions (diet, alcohol, cigarettes, relaxation, hydrotherapie, nature stays, physical activity)
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
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.
Measured: 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.
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
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.
Measured: Week 10
Safety by recording adverse events
Measured: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Adherence to the study intervention
Asking Minutes (min.) of the last week
Measured: 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)
Measured: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 20, week 30, week 40, week 50
Continuation of the intervention
Asking Minutes (min.) of the last month
Measured: 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start4 Sep 2023
- Primary completionJul 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID SyndromeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004362
- Sponsor's protocol ID
- NHKOnline
- Status last verified
- Jan 2024
- First submitted
- 17 Aug 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary and Integrative Medicine as an Online Intervention in Patients With Post-covid Syndrome - a Randomized-controlled Mixed-methods Trial.
- ClinicalTrials.gov ID
- NCT06004362
- Acronym / sponsor ID
- NHKOnline
- Conditions
- Post-COVID Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complementary and Integrative Medicine online intervention, routine care and book | Experimental | Behavioral: Complementary and Integrative Medicine online intervention, routine care and book |
| Routine care and book | Active comparator | Behavioral: Routine care and book |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complementary and Integrative Medicine online intervention, routine care and bookThe 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). | Behavioural | Complementary and Integrative Medicine online intervention, routine care and book |
| Routine care and bookParticipants 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. | Behavioural | Routine care and book |
Primary outcome
Short Form 36 (SF-36), Physical Functioning Scale
Time frame: Baseline, 10 weeks
The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level.
19 secondary outcomes
Short Form 36 (SF-36)
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
DePaul Post-Exertional Malaise Questionnaire (DSQ-PEM)
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Post-COVID-Syndrom (PCS) Score
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Chalder Fatigue Scale (CFS)
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Quality of life (EQ-5D-5L)
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
General Self-Efficacy Scale (GSE, German version: ASKU)
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Visual analog scale (VAS) physical strength
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Visual analog scale (VAS) mental strength
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Visual analog scale (VAS) headache
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Patient Health Questionnaire 9 (PHQ9)
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Lifestyle questions (diet, alcohol, cigarettes, relaxation, hydrotherapie, nature stays, physical activity)
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Expectation regarding study intervention
Time frame: Baseline
Perceived Stress Scale (PSS 4)
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Satisfaction with the intervention
Time frame: Week 10
Safety by recording adverse events
Time frame: Baseline, 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Adherence to the study intervention
Time frame: 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)
Time frame: Week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 20, week 30, week 40, week 50
Continuation of the intervention
Time frame: 10 weeks, 20 weeks, 30 weeks, 40 weeks, 50 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complementary and Integrative Medicine online intervention, routine care and book and Routine care and book in people with Post-COVID Syndrome, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam Rösner (004980505682, naturheilkunde.studien@immanuel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form 36 (SF-36), Physical Functioning Scale (time frame: Baseline, 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024.