A Longitudinal Study on Longstanding Complicated Fatigue

NCT04955587 | Active Not Recruiting

• 1 other identifier: EPN2018/1438-31
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Fatigue Syndrome; Burnout; Covid19

Outcome Measures

Primary Outcomes (8)

• 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.

  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.

  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.

  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.

  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.

  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.

  6 months

• Nutritional status

  The participants take the Organix Basic test by Nordic Laboratories at month six.

  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

  baseline and 1, 2, 4, 6, 12, 18 and 24 months

Secondary Outcomes (2)

• Change in insomnia score (insomnia severity index)

  baseline and 1, 2, 4, 6, 12, 18 and 24 months

• Gastrointestinal symptom burden (gastrointestinal symptom rating scale)

  6 and 18 months

Other Outcomes (5)

• Attention deficit hyperactivity disorder (ADHD)

  baseline

• Burnout

  baseline

• Perfectionism

  baseline

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stockholm University: lead
• Karolinska University Hospital: collaborator
• Karolinska Institutet: collaborator
• Linkoeping University: collaborator

Study Sites (1)

Karolinska University Hospital Solna, dep medical psychology

Stockholm, Sweden

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Plasma Urine

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Burnout, Psychological; COVID-19

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Anna Andreasson, A Prof

  Stockholm University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 9, 2021
• Study Start: August 24, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

SE (1)