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

Study Overview
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Brief Summary
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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.

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

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

Conditions
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Psychological Adaptation, Cognitive Change, Adaptive Behavior, Functioning

Intervention / Treatment
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* Behavioral: Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)


Participation Criteria
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Eligibility Criteria
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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 Have an interest to learn about psychological functioning and how to use this knowledge in rehabilitation or everyday life 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Research group ME/CFS<br>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 | Behavioral: Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)<br>* Adaptation (support own agency), rehabilitation and improvement of functional capacity.<br>|
| Experimental: Control group ME/CFS<br>Control group 6 sessions in 3 months n=35-40 patients Health, lifestyle and wellbeing counselling (sleep, nutrition, activities in daily life) | Behavioral: Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)<br>* Adaptation (support own agency), rehabilitation and improvement of functional capacity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep breathing, Psychological intervention, Cognitive Behavioral Therapy (CBT), Accept and Commitment Therapy (ACT), Cognitive functioning, Fatigue, Autonomic nervous system, Autonomic nervous system ganglio antibodies, Relaxation, Health care system, Agency, Health psychology, Pacing