Chronic Fatigue SyndromeNCT04955587
A Longitudinal Study on Longstanding Complicated Fatigue
An observational study of Chronic Fatigue Syndrome and Burnout, run by Stockholm University at 1 site in Sweden.
Trial summary
The purpose of the study is to investigate if there are common biopsychosocial vulnerability factors for developing and maintaining fatigue, regardless of the diagnosis. The investigators also believe that subgroups differ in terms of these factors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Fatigue Syndrome, Burnout, Covid19
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 24 Aug 2021to Aug 2026
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of adult patients with a diagnosis of ME/CFS, burnout syndrome or post-COVID-19-syndrome. Control groups with rheumatoid arthritis and healthy controls are also included.
Who may be able to join
- Diagnosis set within Stockholm County of ME/CFS, burnout syndrome or post-COVID-19-syndrome according to the Swedish version of the international classification of disease (ICD)-10
- Control group (rheumatic disease): Diagnosis of rheumatoid arthritis
- Control group (healthy): no diagnosis related to inflammatory disease or fatigue
Who cannot join
- Organic or neuropsychiatric disease that explain the fatigue among cases diagnosed with ME/CFS, burnout syndrome or post-COVID-19-syndrome according to the Swedish ICD-10
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska University Hospital Solna, dep medical psychology
Stockholm
About this study
Official title: A Longitudinal Study on Longstanding Complicated Fatigue: Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS), Burnout Syndrome and Post-covid Fatigue
The purpose of the study is to investigate if there are common biopsychosocial vulnerability factors for developing and maintaining fatigue, regardless of the diagnosis. The investigators also believe that subgroups differ in terms of these factors. Participating patients with ME/CFS, burnout syndrome and post-covid fatigue complete a web form at inclusion and after 1, 2, 4, 6, 12, 18 and 24 months. There is no upper limit for the number of participants in the web survey. 150 participants are asked to submit blood samples at a local laboratory in connection with the questionnaires for analysis of inflammatory markers and one urine sample for analysis of nutritional markers. Two control groups are included, 150 patients with rheumatoid arthritis and 50 healthy individuals. The longitudinal design makes it possible to investigate how inflammatory markers, nutritional status, symptom burden, health related quality of life co-vary over time and how work ability and sick leave is affected.
Read the detailed description
Fatigue is associated with impaired health and severely impaired quality of life and function and there is a need to explore similarities and differences regarding biopsychosocial vulnerability and maintenance factors and consequences in terms of work ability and sick leave in chronic fatigue syndrome (ME / CFS), burnout syndrome (BS) and post-covid fatigue to be able to improve individualized interventions for patient with persistent fatigue. The study examines inflammatory markers, nutritional status, symptom burden, neuropsychiatric conditions, work ability, and sick leave in a longitudinal cohort study over 2 years in patients with different diagnoses who all suffer from persistent fatigue. The hypothesis is that there are common biopsychosocial vulnerability factors for developing and maintaining fatigue, regardless of the diagnosis. The investigators also believe that subgroups can be identified that differ in terms of these factors. The longitudinal design makes it possible to investigate how inflammatory markers, nutritional status, symptom burden, health related quality of life co-vary over time and how work ability and sick leave is affected.
In this study participating patients with ME/CFS, BS and post-covid fatigue complete a web form at inclusion and after 1, 2, 4, 6, 12, 18 and 24 months.
Adult patients registered with a diagnosis of chronic complicated fatigue (ME/CFS or post-covid syndrome) in Take Care (medical record system in Stockholm County, Sweden) or with burnout syndrome from Stressmottagningen Stockholm, will be asked to participate in the study.
- Patients with ME/CFS will be recruited at the Department of Behavior Medicine, Karolinska University Hospital Solna or reached by advertising on social media
- Patients with Post-covid-syndrome will be recruited at Karolinska University Hospital or reached by advertising on social media
- Patients with burnout syndrome will be recruited at Stressmottagningen Stockholm
At baseline, a clinical assessment is performed at the clinic and the patient is asked to leave a venous blood sample and complete a questionnaire. The patients are asked for further blood samples and questionnaires at 1, 2, 4, 6, 12, 18, and 24 months after baseline. 150 participants, 50 in each diagnostic group, are asked to submit blood samples for biobanking at a local laboratory in connection to the questionnaire time points for analysis of inflammatory markers. C-reactive protein (CRP) is analysed at the time of blood samples. They are also asked to give one urine sample for analysis of nutritional markers and to submit a 3-day diet diary for evaluation of dietary intake by a registered dietitian. Participants that only fill out the web-based questionnaire will be included. There is no upper limit for the number of participants in the web survey.
A pilot study with 20 participants with ME/CFS started in 2018 to test and revise the design of the present study. These subjects will be counted in the group of 50 participants with ME/CFS diagnosis when available data allow.
In addition to the participants with persistent fatigue, two control groups are included in the study. 150 patients with rheumatoid arthritis (RA) recruited from the Karolinska University Hospital Rheumatology department and 50 healthy controls. The RA controls fill out the illness generic questionnaires on paper and disease information is taken from the national registry for rheumatic disease and CRP and erythrocyte sedimentation rate (ESR) data is taken from the medical record. The healthy controls follow the same procedure as the patients with persistent fatigue but only fill out the form and give blood samples at one time point.
Research questions:
- Are there differences in patient reported fatigue dimensions, symptom burden including post exertional malaise, sleep disorders, health related quality of life, or inflammatory markers, nutritional markers and dietary intake, between patients with ME/CFS, BS and post-covid fatigue, patients with RA and healthy controls?
- Are inflammatory markers and nutritional status associated with the development/recovery of fatigue and symptom burden in ME/CFS, BS and post-covid fatigue?
- Can different subtypes of patients be identified based on latent factor analysis including fatigue dimensions, symptom profile, neuropsychiatric symptoms, inflammatory markers and nutritional status?
- How does inflammatory markers, nutritional status, symptom burden and health related quality of life influence work ability and sick leave in patients with persistent fatigue over time?
The project group consists of a multidisciplinary team from Stockholm and Linköping universities as well as clinically active at clinics in the two regions who often meet patients with persistent fatigue.
- Conditions
- Chronic Fatigue Syndrome, Burnout, Covid19
- Medical subject headings
- Fatigue Syndrome, Chronic, Burnout, Psychological, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with longstanding complicated fatigue | The participants receive no intervention as part of this study. | |
| Healthy controls | The participants receive no intervention as part of this study. | |
| Controls with rheumatic disease | The participants receive no intervention as part of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue (Multidimensional Fatigue Inventory)
The Multidimensional Fatigue Inventory (MFI)-20 assesses five dimensions of fatigue. MFI-20 has an even proportion of positively and negatively worded items that are rated on a 5-point Likert scale. Subscale scores (range 4-20) are calculated as the sum of item ratings and a total fatigue score (range 20-100) is calculated as the sum of subscale scores. Higher scores indicate a higher level of fatigue. The participants completes the MFI at baseline and after 1, 2, 4, 6, 12, 18 and 24 months.
Measured: baseline and 1, 2, 4, 6, 12, 18 and 24 months
Change in symptom burden
Symptom burden is assessed with a checklist and severity rating of the symptoms in the Canada criteria for ME/CFS. The checklist consists of 25 symptoms rated as present/non present. Severity of present symptoms are rated on a 4-point scale. The total score of 0-125 points with a higher score corresponding to a higher symptom burden. The participants completes this form at baseline and after 1, 2, 4, 6, 12, 18 and 24 months.
Measured: baseline and 1, 2, 4, 6, 12, 18 and 24 months
Change in Generalized sickness behavior (Sickness questionnaire)
The sickness questionnaire assesses symptoms of sickness behavior. 10 items are rated on a 4-point Likert scale, total score ranges from 0-30, the higher the scores the more symptoms. The participants completes the the Sickness questionnaire at baseline and after 1, 2, 4, 6, 12, 18 and 24 months.
Measured: baseline and 1, 2, 4, 6, 12, 18 and 24 months
Change in health related quality of life (World health organization disability assessment scale)
The 12-item scale is summarized to a score of 0-100 and a higher score represents a worse quality of life/functioning. The participants completes WHO disability assessment scale (WHODAS) 2.0 at baseline and after 1, 2, 4, 6, 12, 18 and 24 months.
Measured: baseline and 1, 2, 4, 6, 12, 18 and 24 months
Change in Inflammatory markers
Inflammatory markers will be analysed in collaboration with Linköping University at the end of the study. State of the art methods available at study completion will be used. The participants donate blood sample at baseline and after 1, 2, 4, 6, 12, 18 and 24 months. C-reactive protein is analyzed at the time of blood sampling.
Measured: baseline and 1, 2, 4, 6, 12, 18 and 24 months
Dietary intake
The participants complete 3 day diet diaries at month 6 that are analysed by a registered dietitian.
Measured: 6 months
Nutritional status
The participants take the Organix Basic test by Nordic Laboratories at month six.
Measured: 6 months
Change in self-reported work ability
The participants report their sick leave (in %, higher % higher sick leave) and work ability (in percent, higher percent higher work ability) at baseline and after 1, 2, 4, 6, 12, 18 and 24 months
Measured: baseline and 1, 2, 4, 6, 12, 18 and 24 months
Secondary outcomes (2)
Change in insomnia score (insomnia severity index)
Insomnia severity index (ISI) is completed at baseline and after 1, 2, 4, 6, 12, 18 and 24 months. ISI consists of 7 items with a total score ranging from 0 to 28 points, where a higher score corresponds to worse symptoms.
Measured: baseline and 1, 2, 4, 6, 12, 18 and 24 months
Gastrointestinal symptom burden (gastrointestinal symptom rating scale)
The participant completes the gastrointestinal symptom rating scale (GSRS-IBS) at 6 and 18 months. The GSRS-IBS includes 13 items that measure the severity of IBS symptoms in five clusters (pain, bloating, constipation, diarrhea, and early satiety) during the last seven days. The items are scored between 1 and 7, where 1 corresponds to "no discomfort at all" and 7 to "very severe discomfort" from the symptom. Total score ranges from 13 to 91, with a higher score corresponding to a higher symptom burden.
Measured: 6 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start24 Aug 2021
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Fatigue 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Stockholm University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Karolinska Institutet, Linkoeping University
- Responsible party
- Principal investigator, Anna Andreasson, Stockholm University
- Investigators
- Anna Andreasson, A Prof, Principal investigator, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955587
- Sponsor's protocol ID
- EPN2018/1438-31
- Status last verified
- May 2025
- First submitted
- 14 Jun 2021
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- 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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study on Longstanding Complicated Fatigue: Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS), Burnout Syndrome and Post-covid Fatigue
- ClinicalTrials.gov ID
- NCT04955587
- Acronym / sponsor ID
- EPN2018/1438-31
- Conditions
- Chronic Fatigue Syndrome, Burnout, Covid19
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Karolinska Institutet, Linkoeping University
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 9 Jul 2021 (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 purpose of the study is to investigate if there are common biopsychosocial vulnerability factors for developing and maintaining fatigue, regardless of the diagnosis. The investigators also believe that subgroups differ in terms of these factors. Participating patients with ME/CFS, burnout syndrome and post-covid fatigue complete a web form at inclusion and after 1, 2, 4, 6, 12, 18 and 24 months. There is no upper limit for the number of participants in the web survey. 150 participants are asked to submit blood samples at a local laboratory in connection with the questionnaires for analysis of inflammatory markers and one urine sample for analysis of nutritional markers. Two control groups are included, 150 patients with rheumatoid arthritis and 50 healthy individuals. The longitudinal design makes it possible to investigate how inflammatory markers, nutritional status, symptom burden, health related quality of life co-vary over time and how work ability and sick leave is affected.
Detailed description
Fatigue is associated with impaired health and severely impaired quality of life and function and there is a need to explore similarities and differences regarding biopsychosocial vulnerability and maintenance factors and consequences in terms of work ability and sick leave in chronic fatigue syndrome (ME / CFS), burnout syndrome (BS) and post-covid fatigue to be able to improve individualized interventions for patient with persistent fatigue. The study examines inflammatory markers, nutritional status, symptom burden, neuropsychiatric conditions, work ability, and sick leave in a longitudinal cohort study over 2 years in patients with different diagnoses who all suffer from persistent fatigue. The hypothesis is that there are common biopsychosocial vulnerability factors for developing and maintaining fatigue, regardless of the diagnosis. The investigators also believe that subgroups can be identified that differ in terms of these factors. The longitudinal design makes it possible to investigate how inflammatory markers, nutritional status, symptom burden, health related quality of life co-vary over time and how work ability and sick leave is affected.
In this study participating patients with ME/CFS, BS and post-covid fatigue complete a web form at inclusion and after 1, 2, 4, 6, 12, 18 and 24 months.
Adult patients registered with a diagnosis of chronic complicated fatigue (ME/CFS or post-covid syndrome) in Take Care (medical record system in Stockholm County, Sweden) or with burnout syndrome from Stressmottagningen Stockholm, will be asked to participate in the study.
- Patients with ME/CFS will be recruited at the Department of Behavior Medicine, Karolinska University Hospital Solna or reached by advertising on social media
- Patients with Post-covid-syndrome will be recruited at Karolinska University Hospital or reached by advertising on social media
- Patients with burnout syndrome will be recruited at Stressmottagningen Stockholm
At baseline, a clinical assessment is performed at the clinic and the patient is asked to leave a venous blood sample and complete a questionnaire. The patients are asked for further blood samples and questionnaires at 1, 2, 4, 6, 12, 18, and 24 months after baseline. 150 participants, 50 in each diagnostic group, are asked to submit blood samples for biobanking at a local laboratory in connection to the questionnaire time points for analysis of inflammatory markers. C-reactive protein (CRP) is analysed at the time of blood samples. They are also asked to give one urine sample for analysis of nutritional markers and to submit a 3-day diet diary for evaluation of dietary intake by a registered dietitian. Participants that only fill out the web-based questionnaire will be included. There is no upper limit for the number of participants in the web survey.
A pilot study with 20 participants with ME/CFS started in 2018 to test and revise the design of the present study. These subjects will be counted in the group of 50 participants with ME/CFS diagnosis when available data allow.
In addition to the participants with persistent fatigue, two control groups are included in the study. 150 patients with rheumatoid arthritis (RA) recruited from the Karolinska University Hospital Rheumatology department and 50 healthy controls. The RA controls fill out the illness generic questionnaires on paper and disease information is taken from the national registry for rheumatic disease and CRP and erythrocyte sedimentation rate (ESR) data is taken from the medical record. The healthy controls follow the same procedure as the patients with persistent fatigue but only fill out the form and give blood samples at one time point.
Research questions:
- Are there differences in patient reported fatigue dimensions, symptom burden including post exertional malaise, sleep disorders, health related quality of life, or inflammatory markers, nutritional markers and dietary intake, between patients with ME/CFS, BS and post-covid fatigue, patients with RA and healthy controls?
- Are inflammatory markers and nutritional status associated with the development/recovery of fatigue and symptom burden in ME/CFS, BS and post-covid fatigue?
- Can different subtypes of patients be identified based on latent factor analysis including fatigue dimensions, symptom profile, neuropsychiatric symptoms, inflammatory markers and nutritional status?
- How does inflammatory markers, nutritional status, symptom burden and health related quality of life influence work ability and sick leave in patients with persistent fatigue over time?
The project group consists of a multidisciplinary team from Stockholm and Linköping universities as well as clinically active at clinics in the two regions who often meet patients with persistent fatigue.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with longstanding complicated fatigue | – | –The participants receive no intervention as part of this study. |
| Healthy controls | – | –The participants receive no intervention as part of this study. |
| Controls with rheumatic disease | – | –The participants receive no intervention as part of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients with a diagnosis of ME/CFS, burnout syndrome or post-COVID-19-syndrome. Control groups with rheumatoid arthritis and healthy controls are also included.
Key inclusion criteria (3 listed)
- Diagnosis set within Stockholm County of ME/CFS, burnout syndrome or post-COVID-19-syndrome according to the Swedish version of the international classification of disease (ICD)-10
- Control group (rheumatic disease): Diagnosis of rheumatoid arthritis
- Control group (healthy): no diagnosis related to inflammatory disease or fatigue
Key exclusion criteria (1 listed)
- Organic or neuropsychiatric disease that explain the fatigue among cases diagnosed with ME/CFS, burnout syndrome or post-COVID-19-syndrome according to the Swedish ICD-10
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in fatigue (Multidimensional Fatigue Inventory)
Time frame: baseline and 1, 2, 4, 6, 12, 18 and 24 months
The Multidimensional Fatigue Inventory (MFI)-20 assesses five dimensions of fatigue. MFI-20 has an even proportion of positively and negatively worded items that are rated on a 5-point Likert scale. Subscale scores (range 4-20) are calculated as the sum of item ratings and a total fatigue score (range 20-100) is calculated as the sum of subscale scores. Higher scores indicate a higher level of fatigue. The participants completes the MFI at baseline and after 1, 2, 4, 6, 12, 18 and 24 months.
Change in symptom burden
Time frame: baseline and 1, 2, 4, 6, 12, 18 and 24 months
Symptom burden is assessed with a checklist and severity rating of the symptoms in the Canada criteria for ME/CFS. The checklist consists of 25 symptoms rated as present/non present. Severity of present symptoms are rated on a 4-point scale. The total score of 0-125 points with a higher score corresponding to a higher symptom burden. The participants completes this form at baseline and after 1, 2, 4, 6, 12, 18 and 24 months.
Change in Generalized sickness behavior (Sickness questionnaire)
Time frame: baseline and 1, 2, 4, 6, 12, 18 and 24 months
The sickness questionnaire assesses symptoms of sickness behavior. 10 items are rated on a 4-point Likert scale, total score ranges from 0-30, the higher the scores the more symptoms. The participants completes the the Sickness questionnaire at baseline and after 1, 2, 4, 6, 12, 18 and 24 months.
Change in health related quality of life (World health organization disability assessment scale)
Time frame: baseline and 1, 2, 4, 6, 12, 18 and 24 months
The 12-item scale is summarized to a score of 0-100 and a higher score represents a worse quality of life/functioning. The participants completes WHO disability assessment scale (WHODAS) 2.0 at baseline and after 1, 2, 4, 6, 12, 18 and 24 months.
Change in Inflammatory markers
Time frame: baseline and 1, 2, 4, 6, 12, 18 and 24 months
Inflammatory markers will be analysed in collaboration with Linköping University at the end of the study. State of the art methods available at study completion will be used. The participants donate blood sample at baseline and after 1, 2, 4, 6, 12, 18 and 24 months. C-reactive protein is analyzed at the time of blood sampling.
Dietary intake
Time frame: 6 months
The participants complete 3 day diet diaries at month 6 that are analysed by a registered dietitian.
Nutritional status
Time frame: 6 months
The participants take the Organix Basic test by Nordic Laboratories at month six.
Change in self-reported work ability
Time frame: baseline and 1, 2, 4, 6, 12, 18 and 24 months
The participants report their sick leave (in %, higher % higher sick leave) and work ability (in percent, higher percent higher work ability) at baseline and after 1, 2, 4, 6, 12, 18 and 24 months
2 secondary outcomes
Change in insomnia score (insomnia severity index)
Time frame: baseline and 1, 2, 4, 6, 12, 18 and 24 months
Gastrointestinal symptom burden (gastrointestinal symptom rating scale)
Time frame: 6 and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- 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.
Anna Andreasson, A Prof principal investigator
Stockholm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Fatigue Syndrome and Burnout, run by Stockholm University at 1 site in Sweden.
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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 22 May 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in fatigue (Multidimensional Fatigue Inventory) (time frame: baseline and 1, 2, 4, 6, 12, 18 and 24 months). The study lists 8 primary outcomes in all. 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 22 May 2025.