Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- COMPASS31
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •(diseases without treatment/ acute phase):
- •hypothyroidism
- •sleep apnea or narcolepsy
- •major depressive disorders, bipolar affective disorders, schizophrenia
- •eating disorders
- •autoimmune disease
- •hormonal disorders
- •subacute infections
- •alcohol or substance abuse
- •vitamin D deficiency
结局指标
主要结局
COMPASS31
时间窗: 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.
WHODAS 22.0 (World Health Organization Disability Assessment Schedule) 2.0.
时间窗: 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
次要结局
- HADS (Hospital Anxiety and Depression Scale)(Before intervention and change immediately after the intervention and 3 months follow up)
- SOC-14 (Sense Of Coherence)(Before intervention and change immediately after the intervention and 3 months follow up)
- PHQ-4 (patient health questionnaire)(Before intervention and change immediately after the intervention and 3 months follow up)
- FSS (Fatigue severity scale)(Before intervention and change immediately after the intervention and 3 months follow up)