Clinical trial NCT04151693: Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
Official title: Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Adaptation
Cognitive Change
Adaptive Behavior
Functioning
Keywords: Psychological intervention
Cognitive Behavioral Therapy (CBT)
Accept and Commitment Therapy (ACT)
Cognitive functioning
Fatigue
Autonomic nervous system
Autonomic nervous system ganglio antibodies
Deep breathing
Relaxation
Health care system
Agency
Health psychology
Pacing
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
Collaborators: name: TheWellbeing Services County of Pirkanmaa
name: Charite-Institute of Medical Immunology
First posted: 2019-11-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Research group, 35-40 participants (8 sessions in 4 months) Control group (health and lifestyle counselling), 35-40 participants (6 sessions in 3 months)
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: WHODAS 22.0 (World Health Organization Disability Assessment Schedule) 2.0.
timeFrame: Before intervention and change immediately after the intervention and 3 months follow up
measure: COMPASS31
timeFrame: Before intervention and change immediately after the intervention and 3 months follow up
Secondary outcomes:
measure: HADS (Hospital Anxiety and Depression Scale)
timeFrame: Before intervention and change immediately after the intervention and 3 months follow up
measure: SOC-14 (Sense Of Coherence)
timeFrame: Before intervention and change immediately after the intervention and 3 months follow up
measure: FSS (Fatigue severity scale)
timeFrame: Before intervention and change immediately after the intervention and 3 months follow up
measure: PHQ-4 (patient health questionnaire)
timeFrame: Before intervention and change immediately after the intervention and 3 months follow up
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: Päijät Häme Central Hospital
Study officials:
affiliation: Päijät- Häme Joint Authority for Health and Wellbeing
name: Tuomo Nieminen
role: STUDY_CHAIR
References: