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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJoint Authority for Päijät-Häme Social and Health Care

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

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

    Behavioral

    Adaptation (support own agency), rehabilitation and improvement of functional capacity.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Research group ME/CFSExperimental treatment 1 intervention
Group B: Control group ME/CFSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Joint Authority for Päijät-Häme Social and Health Care

Lead sponsor

TheWellbeing Services County of Pirkanmaa

Collaborator

Charite-Institute of Medical Immunology

Collaborator