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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Change; Psychological Adaptation; Adaptive Behavior; Functioning
• Intervention / Treatment: Behavioral: Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Suoma Saarni, professor; Phone Number: +358440773073; Email: suoma.saarni@paijatha.fi
• Study Contact Backup: Name: Meeri Keurulainen, phd student; Phone Number: +358447195045; Email: meeri.keurulainen@paijatha.fi

Study Locations

• Finland
  • Lahti, Finland
    • Recruiting
    • Päijät Häme Central Hospital
    • Contact: Meeri Keurulainen, MSci; Email: meeri.keurulainen@paijatha.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Research group ME/CFS; 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); Adaptation (support own agency), rehabilitation and improvement of functional capacity.
Experimental: Control group ME/CFS; 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); Adaptation (support own agency), rehabilitation and improvement of functional capacity.

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Joint Authority for Päijät-Häme Social and Health Care
• Collaborators: TheWellbeing Services County of Pirkanmaa; Charite-Institute of Medical Immunology
• Investigators: Study Chair: Tuomo Nieminen, Päijät- Häme Joint Authority for Health and Wellbeing

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2019
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Fatigue; Relaxation; Autonomic nervous system; Pacing; Cognitive Behavioral Therapy (CBT); Cognitive functioning; Psychological intervention; Accept and Commitment Therapy (ACT); Autonomic nervous system ganglio antibodies; Deep breathing; Health psychology; Health care system; Agency
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Encephalomyelitis; Chronic Disease; Neuroinflammatory Diseases; Fatigue; Fatigue Syndrome, Chronic
• Other Study ID Numbers: D/1964/13.00.00.00/2019 Q 028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No