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

NCT04151693 | Recruiting

• 1 other identifier: D/1964/13.00.00.00/2019 Q 028
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Adaptation; Cognitive Change; Adaptive Behavior; Functioning

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

• FSS (Fatigue severity scale)

  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

Study Arms (2)

Research group ME/CFS

EXPERIMENTAL

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)

Control group ME/CFS

EXPERIMENTAL

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)

Interventions

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

Adaptation (support own agency), rehabilitation and improvement of functional capacity.

Control group ME/CFS; Research group ME/CFS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Joint Authority for Päijät-Häme Social and Health Care: lead
• TheWellbeing Services County of Pirkanmaa: collaborator
• Charite-Institute of Medical Immunology: collaborator

Study Sites (1)

Päijät Häme Central Hospital

Lahti, Finland

RECRUITING

Related Publications (1)

• Keurulainen M, Holma J, Wallenius E, Pankalainen M, Hintikka J, Partinen M. 'I became more aware of my actions'-A qualitative longitudinal study of a health psychological group intervention for patients with myalgic encephalomyelitis/chronic fatigue syndrome. Health Expect. 2023 Dec;26(6):2312-2324. doi: 10.1111/hex.13833. Epub 2023 Aug 1.

  PMID: 37528544 DERIVED

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tuomo Nieminen

  Päijät- Häme Joint Authority for Health and Wellbeing

  STUDY CHAIR

Central Study Contacts

Suoma Saarni, professor

CONTACT

+358440773073; suoma.saarni@paijatha.fi

Meeri Keurulainen, phd student

CONTACT

+358447195045; meeri.keurulainen@paijatha.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Research group, 35-40 participants (8 sessions in 4 months) Control group (health and lifestyle counselling), 35-40 participants (6 sessions in 3 months)

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: November 5, 2019
• Study Start: November 30, 2019
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)