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

Sponsor

Joint Authority for Päijät-Häme Social and Health Care (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04151693

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Psychological Adaptation Cognitive Change	Behavioral: CBT-based group therapy for patients with chronic fatigue syndrome (CFS)	N/A

Detailed Description

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.

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).
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)
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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)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 (Outcomes Assessor)

Masking Description:

Laboratory measurements autonomic nervous system ganglio antibodies.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 31, 2019

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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	Behavioral: CBT-based group therapy for patients with chronic fatigue syndrome (CFS) Goal is to relief patients anxiety and offer to learn better coping skills in situation where patients functioning in everyday life is difficult.
Experimental: Control group CFS Control group 6 sessions in 3 months n=35-40 patients Health, lifestyle and wellbeing counselling (sleep, nutrition, performance)	Behavioral: CBT-based group therapy for patients with chronic fatigue syndrome (CFS) Goal is to relief patients anxiety and offer to learn better coping skills in situation where patients functioning in everyday life is difficult.

Arm

Intervention/Treatment

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

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

Goal is to relief patients anxiety and offer to learn better coping skills in situation where patients functioning in everyday life is difficult.

Experimental: Control group CFS

Control group 6 sessions in 3 months n=35-40 patients Health, lifestyle and wellbeing counselling (sleep, nutrition, performance)

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

Goal is to relief patients anxiety and offer to learn better coping skills in situation where patients functioning in everyday life is difficult.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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-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)
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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