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| Name | Class |
|---|---|
| TheWellbeing Services County of Pirkanmaa | UNKNOWN |
| Charite-Institute of Medical Immunology | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Research group ME/CFS | Experimental | 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 |
|
| Control group ME/CFS | Experimental | Control group 6 sessions in 3 months n=35-40 patients Health, lifestyle and wellbeing counselling (sleep, nutrition, activities in daily life) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS) | Behavioral | Adaptation (support own agency), rehabilitation and improvement of functional capacity. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | Before intervention and change immediately after the intervention and 3 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Before intervention and change immediately after the intervention and 3 months follow up |
| SOC-14 (Sense Of Coherence) |
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Inclusion Criteria:
Exclusion Criteria (diseases without treatment/ acute phase):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suoma Saarni, professor | Contact | +358440773073 | suoma.saarni@paijatha.fi | |
| Meeri Keurulainen, phd student | Contact | +358447195045 | meeri.keurulainen@paijatha.fi |
| Name | Affiliation | Role |
|---|---|---|
| Tuomo Nieminen | Päijät- Häme Joint Authority for Health and Wellbeing | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Päijät Häme Central Hospital | Recruiting | Lahti | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37528544 | Derived | Keurulainen M, Holma J, Wallenius E, Pankalainen M, Hintikka J, Partinen M. 'I became more aware of my actions'-A qualitative longitudinal study of a health psychological group intervention for patients with myalgic encephalomyelitis/chronic fatigue syndrome. Health Expect. 2023 Dec;26(6):2312-2324. doi: 10.1111/hex.13833. Epub 2023 Aug 1. |
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Research group, 35-40 participants (8 sessions in 4 months) Control group (health and lifestyle counselling), 35-40 participants (6 sessions in 3 months)
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Sense of coherence, inventory, 14 questions, scale 0-7. Total score is reported/ scores are reported on subscales: (comprehensibility, manageability, meaningfulness) |
| 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. | 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) | Before intervention and change immediately after the intervention and 3 months follow up |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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