Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
NCT04151693 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2024-04-03
Summary
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.
Conditions
- Psychological Adaptation
- Cognitive Change
- Adaptive Behavior
- Functioning
Interventions
- BEHAVIORAL
-
Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
Adaptation (support own agency), rehabilitation and improvement of functional capacity.
Sponsors & Collaborators
-
TheWellbeing Services County of Pirkanmaa
collaborator UNKNOWN -
Charite-Institute of Medical Immunology
collaborator UNKNOWN -
Joint Authority for Päijät-Häme Social and Health Care
lead OTHER
Principal Investigators
-
Tuomo Nieminen · Päijät- Häme Joint Authority for Health and Wellbeing
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-11-30
- Primary Completion
- 2028-05-31
- Completion
- 2028-05-31
Countries
- Finland
Study Locations
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