About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
hypothyroidism
sleep apnea or narcolepsy
major depressive disorders, bipolar affective disorders, schizophrenia
eating disorders
Trial design
Parallel
Treatments tested in this trial
Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
BehavioralAdaptation (support own agency), rehabilitation and improvement of functional capacity.
Treatment groups
Trial outcomes
Primary outcomes
WHODAS 22.0 (World Health Organization Disability Assessment Schedule) 2.0.
36 questions, scale 0-5 (not difficult at all-very difficult) Subscales: 1)communication with other people 2) Mobility/ movement in everyday activities 3)Daily functions and taking care of oneself 4) Relationships 5) Daily routines 6) Disabilities in last 30 days 7)Participating on community
COMPASS31
Autonomic nervous system/ neurological symptoms, inventory,31 questions. Subscales: different neurological symptoms, scales from 0-1 to 0-7. Score is reported on subscales.
Secondary outcomes
HADS (Hospital Anxiety and Depression Scale)
Depression and anxiety, inventory,14 questions, scale 0-3. Total score is reported (0-7:normal- 8-10:borderline-11-21:abnormal)
SOC-14 (Sense Of Coherence)
Sense of coherence, inventory, 14 questions, scale 0-7. Total score is reported/ scores are reported on subscales: (comprehensibility, manageability, meaningfulness)
FSS (Fatigue severity scale)
Fatigue severity scale,9 questions, scale 0-7 (I strongly disagree- I strongly agree) total score is reported.
PHQ-4 (patient health questionnaire)
Depression and anxiety, inventory, 4 guestions. Subscales: anxiety and depression. Total score is reported ( 0-1 none,3-5 mild, 6-8 moderate, 10-12 severe)
Sponsors and contacts
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Joint Authority for Päijät-Häme Social and Health Care
Lead sponsor
TheWellbeing Services County of Pirkanmaa
Collaborator
Charite-Institute of Medical Immunology
Collaborator