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CBT Based Group Therapy for Patients With Chronic Fatigue Syndrome (CFS)

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Вход / Регистрация
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СъстояниеВсе още не набира
Спонсори
Joint Authority for Päijät-Häme Social and Health Care

Ключови думи

Резюме

Chronic fatigue syndrome 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 psychological, cognitive behavioral therapy (CBT) based group intervention for CFS- patients.
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 ortostathic 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.

Описание

Testing and inventories before treatment/ at the end of the treatment and 3 months follow-up:

Inventories: PHQ-4, HADS, BDQ,CFQ, PRMQ, FSS, WHODAS 2.0, SOC- 29, YSQ L3a, Compass31, Pichot, Promis (general health v 1.2 and fatique 7a) and PARKSLEEP.

1. Manual and patients experience. n =6-8 patients. Goal is to collect patients' personal experiences about CBT- treatment. Analysis included inventories, laboratory measurements and transcribed interviews. Mixed methods (comparing statistical data and qualitative content analysis/ agency speech transformation).

2. Therapeutic interventions and agency-speech transformation in CBT-therapy sessions. CBT- sessions are taped and transcribed. Research method: qualitative approach with discourse analysis (agency speech transformation during the intervention, therapeutical interventions in the group therapy)

3. Randomized controlled research. n=70. Treatment/research group n=35. Control- group (35) participates on health counselling (6 sessions). Research question: is CBT-treatment clinically statistically significance. 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.

Дати

Последна проверка: 08/31/2019
Първо изпратено: 09/23/2019
Очаквано записване подадено: 11/03/2019
Първо публикувано: 11/04/2019
Изпратена последна актуализация: 11/03/2019
Последна актуализация публикувана: 11/04/2019
Действителна начална дата на проучването: 10/30/2019
Приблизителна дата на първично завършване: 12/30/2024
Очаквана дата на завършване на проучването: 12/30/2024

Състояние или заболяване

Psychological Adaptation
Cognitive Change

Интервенция / лечение

Behavioral: CBT-based group therapy for patients with chronic fatigue syndrome (CFS)

Фаза

-

Групи за ръце

ArmИнтервенция / лечение
Experimental: Research group CFS
Research treatment for patients with CFS (diagnosed G 93.3). CBT- based group therapy 8 sessions in 4 months. n=35-40 patients Special focus on autonomic nervous system and how it affects the individual (hyperarousal, cognitive disabilities) Psychoeducation and tasks (for example abdominal respiration and mindfulness) learning new coping skills Stress management in every day life
Experimental: Control group CFS
Control group 6 sessions in 3 months n=35-40 patients Health, lifestyle and wellbeing counselling (sleep, nutrition, performance)

Критерии за допустимост

Възрасти, отговарящи на условията за проучване 18 Years Да се 18 Years
Полове, допустими за проучванеAll
Приема здрави доброволциДа
Критерии

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

Резултат

Първични изходни мерки

1. 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

2. 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.

Вторични изходни мерки

1. 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)

2. SOC-29 (Sense Of Coherence) [Before intervention and change immediately after the intervention and 3 months follow up]

Sense of coherence, inventory, 29 questions, scale 0-7. Total score is reported/ scores are reported on subscales: (comprehensibility, manageability, meaningfulness)

3. 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.

4. 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)

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