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

Cognitive Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04151693
• Other study ID #: D/1964/13.00.00.00/2019 Q 028
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2019
• Est. completion date: May 31, 2028

Study information

• Verified date: April 2024
• Source: Joint Authority for Päijät-Häme Social and Health Care
• Contact: Suoma Saarni, professor
• Phone: +358440773073
• Email: suoma.saarni[@]paijatha.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Testing and inventories before rehabilitation/ at the end of the rehabilitation and 3 months follow-up.

1. ME/CFS patients modalities of agency.The study includes five patients with chronic fatigue syndrome and examines their modalities of agency. A special focus is on the effects of the health care system on the patients' agency.The research is qualitative, the data was analyzed using theory-driven content analysis.

2. The study explores the experiences of Health Psychological group rehabilitation for patients with ME/CFS. The aim is to better overall functioning and management of illness through goal-oriented work, dealing emotions with the crisis of the illness, adopting, and implementing healthy lifestyle choices. The study is qualitative (n=10) using content analysis.

3. Randomized controlled research. n=70. Treatment/research group n=35. Control- group (35) participates on health counselling (6 sessions). Research question: is health psychological group rehabilitation clinically statistically significant. Comparison is between research- and control groups but also between patients who are diagnosed 93.3, having also objective impairment in cognitive functions or orthostatic intolerance, comparing to patients only diagnosed on G93.3.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 31, 2028
• Est. primary completion date: May 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

• Have an interest to learn health psychological approach and willingness to participate rehabilitation

Exclusion Criteria (diseases without treatment/ acute phase):

• 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

Related Conditions & MeSH terms

• Cognitive Change
• Fatigue
• Fatigue Syndrome, Chronic
• Functioning
• Psychological Adaptation

Intervention

Behavioral:
• Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
Adaptation (support own agency), rehabilitation and improvement of functional capacity.

Locations

Country	Name	City	State
Finland	Päijät Häme Central Hospital	Lahti

Sponsors (3)

Lead Sponsor	Collaborator
Joint Authority for Päijät-Häme Social and Health Care	Charite-Institute of Medical Immunology, TheWellbeing Services County of Pirkanmaa

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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)	Before intervention and change immediately after the intervention and 3 months follow up
Secondary	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
Secondary	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