Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT04151693

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

Led by Joint Authority for Päijät-Häme Social and Health Care · Updated on 2024-04-03

80

Participants Needed

1

Research Sites

443 weeks

Total Duration

On this page

Sponsors

J

Joint Authority for Päijät-Häme Social and Health Care

Lead Sponsor

T

TheWellbeing Services County of Pirkanmaa

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 orientation
  • Have an interest to learn health psychological approach and willingness to participate in rehabilitation
Not Eligible

You will not qualify if you...

  • Hypothyroidism
  • Sleep apnea or narcolepsy
  • Major depressive disorders, bipolar affective disorders, schizophrenia
  • Eating disorders
  • Cancer
  • Autoimmune disease
  • Hormonal disorders
  • Subacute infections
  • Obesity
  • Alcohol or substance abuse
  • Vitamin D deficiency

AI-Screening

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Trial Site Locations

Total: 1 location

1

Päijät Häme Central Hospital

Lahti, Finland

Actively Recruiting

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Research Team

S

Suoma Saarni, professor

CONTACT

M

Meeri Keurulainen, phd student

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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