An interventional study of Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS) in Psychological Adaptation, Cognitive Change and Adaptive Behavior, sponsored by Joint Authority for Päijät-Häme Social and Health Care. Recruiting at 1 site in Finland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-04-03.
Sponsored by Joint Authority for Päijät-Häme Social and Health Care · Not applicable, Interventional, and Treatment
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.
Testing and inventories before rehabilitation/ at the end of the rehabilitation and 3 months follow-up.
1,912 studies on the registry are indexed under Fatigue; 381 are open to participants now.
This study's planned enrollment of 80 is above the median of 53 across 1,479 interventional studies indexed under Fatigue.
Browse Fatigue studies →Joint Authority for Päijät-Häme Social and Health Care is the lead sponsor of 19 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria (diseases without treatment/ acute phase):
Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS) 8 sessions in 4 months. n=35-40 patients ME/CFS -Current knowledge Smart goals Stress management in every day life Pacing Psychological effects of illness and adaptation Coping strategies Emotional support Focus on autonomic nervous system (hyperarousal, cognitive disabilities) Focus on health
Behavioral: Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
Control group 6 sessions in 3 months n=35-40 patients Health, lifestyle and wellbeing counselling (sleep, nutrition, activities in daily life)
Behavioral: Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
Adaptation (support own agency), rehabilitation and improvement of functional capacity.
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
Time frame: Before intervention and change immediately after the intervention and 3 months follow up
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.
Time frame: Before intervention and change immediately after the intervention and 3 months follow up
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)
Time frame: Before intervention and change immediately after the intervention and 3 months follow up
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)
Time frame: Before intervention and change immediately after the intervention and 3 months follow up
FSS (Fatigue severity scale)
Fatigue severity scale,9 questions, scale 0-7 (I strongly disagree- I strongly agree) total score is reported.
Time frame: Before intervention and change immediately after the intervention and 3 months follow up
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)
Time frame: Before intervention and change immediately after the intervention and 3 months follow up
Plan to share: No
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Joint Authority for Päijät-Häme Social and Health Care