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NCT04151693Recruiting

Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)

Source: ClinicalTrials.gov · Last updated 3 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Chronic fatigue syndrome (ME/CFS) is a severe medical condition. It is characterized by long term fatique and other persisted symptoms, such as a cognitive disabilities and orthostatic intolerance. Symptoms limit a persons ability to carry out ordinary daily activities. In ICD- 10, disease is known as G93.3, postviral fatigue syndrome. The purpose of this research (doctoral study) is to produce a health psychological group intervention for patients with ME/CFS. Research protocol: 70-80 patients with diagnosis G 93.3. Psychological and psychiatric evaluation for patients (SCID I and parts from SCID II). Depression diagnosis is allowed (on remission). Medication for depression is also allowed. Measurements for ortostatic intolerance (Somnotouch nimbTM) and laboratory measurements: complete blood count, CRP, alkaline phosphatase, GT, ALAT, CK, bilirubin, kidney and thyroid (TSH, T4V) function tests, serum ferritin, glucose, electrolytes and daily urine sodium excretion. Autonomic nervous system ganglio antibodies: Anti-AT1R- Antibodies, Anti- ETAR- Antibodies, anti alpha-1 adrenergic Receptor Antibodies, anti alpha 2 adrenergic Receptor Antibodies, anti beta-1 adrenergic Receptor Antibodies, anti beta-2-adrenergic Receptor Antibodies, anti- Muscarinic Cholinergic Receptor 1 (M1)- Antibodies, anti- Muscarinic Cholinergic Receptor 2 (M2)- Antibodies, anti- Muscarinic Cholinergic Receptor 3 (M3)- Antibodies, anti- Muscarinic Cholinergic Receptor 4 (M4)- Antibodies, anti- Muscarinic Cholinergic Receptor 5 (M5)- Antibodies.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
24 Sept 2019
Start date
30 Nov 2019
Primary completion date
31 May 2028
Lead sponsor
Joint Authority for Päijät-Häme Social and Health Care
NCT number
NCT04151693

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 30 Nov 2019 to the primary completion date, 31 May 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • major depressive disorders, bipolar affective disorders, schizophrenia
  • eating disorders
  • cancer
  • autoimmune disease
  • hormonal disorders
  • subacute infections

Other

  • hypothyroidism
  • sleep apnea or narcolepsy
  • obesity
  • alcohol or substance abuse
  • vitamin D deficiency

Who the study is looking for

  • Clinical diagnosis of Chronic fatigue syndrome, G 93.3
  • Must be able to sit two hours and do homework tasks
  • Must be motivated to co-operate with other patients
  • Goal oritentation
  • Have an interest to learn health psychological approach and willingness to participate rehabilitation

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Päijät-Häme Central Hospital
Coordinator of this site? Confirm its status
LahtiFinlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.