Post-COVID-19 SyndromeNASH-POCONCT05798221
Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome
A study testing Complementary self-help strategies in addition to treatment as usual and Treatment as usual in people with Post-COVID-19 Syndrome, run by Universität Duisburg-Essen at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- Complementary self-help strategies in addition to treatment as usual and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteGermany
- Study dates
- 25 Apr 2023to 6 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Center for Integrative Medicine and Planetary Health, University Hospital Essen, University of Duisburg-Essen
Essen
About this study
Official title: Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome: A Randomized Controlled Trial
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.
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- Complementary self-help strategies in addition to treatment as usual, Treatment as usual
- Keywords
- complementary medicine, COVID-19, post-COVID-19 Syndrome, randomized controlled trial, self-help
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complementary self-help strategies in addition to treatment as usualBehavioural
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
Treatment as usualOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Complementary self-help strategies in addition to treatment as usual |
| 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. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 16
Secondary outcomes (18)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 16
Insomnia
Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia
Measured: Week 16
Insomnia
Insomnia Severity Index (ISI): self-report scale from 0 - 28 points with higher score indicating higher level of insomnia
Measured: Week 10
Cardiovascular performance
6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity
Measured: Week 10
Cardiovascular performance
6-Minute-Walking-Test (6MWT): a longer traveled distance indicates a higher level of cardiovascular/pulmonary capacity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 16
Adverse events
All adverse events in relation and unrelated to the intervention
Measured: Weeks 0 - 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start25 Apr 2023
- Primary completion25 Mar 2025
- Study completion6 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidemarie Haller, Universität Duisburg-Essen
- Investigators
- Gustav Dobos, Prof. MD, Study chair, University of Duisburg-EssenHeidemarie Haller, PhD, Principal investigator, University of Duisburg-EssenChristoph Kleinschnitz, Prof. MD, Study director, University of Duisburg-EssenMark Stettner, Prof. MD, Study director, University of Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798221
- Sponsor's protocol ID
- 22-11002-BO
- Acronym
- NASH-POCO
- Status last verified
- Nov 2025
- First submitted
- 2 Apr 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Self-help Strategies for Patients With Post-COVID-19 Syndrome: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05798221
- Acronym / sponsor ID
- NASH-POCO / 22-11002-BO
- Conditions
- Post-COVID-19 Syndrome
- Keywords
- complementary medicine, COVID-19, post-COVID-19 Syndrome, randomized controlled trial, self-help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 6 Oct 2025 (actual)
- First posted
- 4 Apr 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complementary self-help strategies in addition to treatment as usual | Experimental | Behavioral: Complementary self-help strategies in addition to treatment as usualThe 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 | Other: Treatment as usualThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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 self-help strategies in addition to treatment as usualThe 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 | Behavioural | Complementary self-help strategies in addition to treatment as usual |
| Treatment as usualThe 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 |
Primary outcome
Post-COVID-19 symptom burden
Time frame: Week 16
Somatic Symptom Scale-8 (SSS-8): self-report scale from 0 to 32 points with higher scores indicating higher level of burden
18 secondary outcomes
Post-COVID-19 symptom burden
Time frame: Week 10
Post-COVID-19 functional status (self-reported)
Time frame: Week 10
Post-COVID-19 functional status (self-reported)
Time frame: Week 16
Health-related quality of life
Time frame: Week 10
Health-related quality of life
Time frame: Week 16
Fatigue
Time frame: Week 10
Fatigue
Time frame: Week 16
Anxiety and depression
Time frame: Week 10
Anxiety and depression
Time frame: Week 16
Insomnia
Time frame: Week 16
Insomnia
Time frame: Week 10
Cardiovascular performance
Time frame: Week 10
Cardiovascular performance
Time frame: Week 16
Pulmonary performance
Time frame: Week 10
Pulmonary performance
Time frame: Week 16
Post-COVID-19 functional status (physician-reported)
Time frame: Week 10
Post-COVID-19 functional status (physician-reported)
Time frame: Week 16
Adverse events
Time frame: Weeks 0 - 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Post-COVID-19 Syndrome
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Post-Acute COVID-19 Syndrome
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Not yet recruitingPhase 2
Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
Long COVID, COVID-19 (SARS-CoV-2 Infection)
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
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.
Gustav Dobos, Prof. MD study chair
University of Duisburg-Essen
Heidemarie Haller, PhD principal investigator
University of Duisburg-Essen
Christoph Kleinschnitz, Prof. MD study director
University of Duisburg-Essen
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 self-help strategies in addition to treatment as usual and Treatment as usual in people with Post-COVID-19 Syndrome, run by Universität Duisburg-Essen 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 19 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-COVID-19 symptom burden (time frame: Week 16). 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 19 Nov 2025.