Adaptive Behavior, Cognitive Change, Functioning, Psychological Adaptation
Conditions
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
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.
Interventions
BEHAVIORALHealth Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
Adaptation (support own agency), rehabilitation and improvement of functional capacity.
Sponsors
TheWellbeing Services County of Pirkanmaa
Charite-Institute of Medical Immunology
Joint Authority for Päijät-Häme Social and Health Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| WHODAS 22.0 (World Health Organization Disability Assessment Schedule) 2.0. | Before intervention and change immediately after the intervention and 3 months follow up | 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 |
| COMPASS31 | Before intervention and change immediately after the intervention and 3 months follow up | Autonomic nervous system/ neurological symptoms, inventory,31 questions. Subscales: different neurological symptoms, scales from 0-1 to 0-7. Score is reported on subscales. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HADS (Hospital Anxiety and Depression Scale) | Before intervention and change immediately after the intervention and 3 months follow up | Depression and anxiety, inventory,14 questions, scale 0-3. Total score is reported (0-7:normal- 8-10:borderline-11-21:abnormal) |
| SOC-14 (Sense Of Coherence) | Before intervention and change immediately after the intervention and 3 months follow up | Sense of coherence, inventory, 14 questions, scale 0-7. Total score is reported/ scores are reported on subscales: (comprehensibility, manageability, meaningfulness) |
| FSS (Fatigue severity scale) | Before intervention and change immediately after the intervention and 3 months follow up | Fatigue severity scale,9 questions, scale 0-7 (I strongly disagree- I strongly agree) total score is reported. |
| PHQ-4 (patient health questionnaire) | Before intervention and change immediately after the intervention and 3 months follow up | 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) |
Countries
Finland
Contacts
Primary ContactSuoma Saarni, professor
Backup ContactMeeri Keurulainen, phd student
Outcome results
None listed