An observational study in Chronic Fatigue Syndrome, Burnout and Covid19, sponsored by Stockholm University. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Stockholm University · Observational
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.
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.
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:
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.
246 studies on the registry are indexed under Fatigue Syndrome, Chronic; 58 are open to participants now.
This study's planned enrollment of 150 is close to the median of 150 across 71 observational studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →Stockholm University is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
The participants receive no intervention as part of this study.
The participants receive no intervention as part of this study.
The participants receive no intervention as part of this study.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Nutritional status
The participants take the Organix Basic test by Nordic Laboratories at month six.
Time frame: 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
Time frame: baseline and 1, 2, 4, 6, 12, 18 and 24 months
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.
Time frame: 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.
Time frame: 6 and 18 months
Attention deficit hyperactivity disorder (ADHD)
Adult ADHD self-report scale (ASRS). ASRS consists of 18 questions in two parts rated on a 5-point scale where a higher score corresponds to a higher symptom burden. Possible range 0-72 points.
Time frame: baseline
Burnout
Shirom-Melamed Burnout Questionnaire (SMBQ)-22 consists of 22 items rated on a 7-point rating scale where a higher total score corresponds to a higher symptom level (range 22-145).
Time frame: baseline
Perfectionism
Clinical Perfectionism Questionnaire (CPQ) consists of 12 statements rated on a 4-point Likert scale (range total score 4-48), a higher score corresponds to a higher rate of perfectionism
Time frame: baseline
Attention spectrum disorder (ASD)
Ritvo Autism and Asperger Diagnostic Scale (RAADS)-14 consists of 14 statements rated on a 4-point scale with a total score ranging from 0-42, with a higher score corresponding to more severe symptoms.
Time frame: baseline
Presence of hypermobility
Participants complete the 5 PQ questionnaire for hypermobility at one time point. The questionnaire includes 5 items answered Yes/no, where 2 or more affirmations are indicative of hypermobility.
Time frame: baseline
Plan to share: Undecided
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This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Stockholm University