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NCT Number: NCT04151693

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.

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Key information

Conditions

Psychological Adaptation Adaptive Behavior Cognitive Change Fatigue Functioning Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Päijät Häme Central Hospital

Lahti, Finland

Location status: Recruiting

Location contact

Meeri Keurulainen, MSci

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

Primary outcomes

  1. WHODAS 22.0 (World Health Organization Disability Assessment Schedule) 2.0.

    Time frame: 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

    Time frame: 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 outcomes

  1. HADS (Hospital Anxiety and Depression Scale)

    Time frame: 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-14 (Sense Of Coherence)

    Time frame: Before intervention and change immediately after the intervention and 3 months follow up

    Sense of coherence, inventory, 14 questions, scale 0-7. Total score is reported/ scores are reported on subscales: (comprehensibility, manageability, meaningfulness)

  3. FSS (Fatigue severity scale)

    Time frame: 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)

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Meeri Keurulainen, phd student

CONTACT

[email protected]

+358447195045

Suoma Saarni, professor

CONTACT

[email protected]

+358440773073

Sponsors and collaborators

Lead sponsor

Joint Authority for Päijät-Häme Social and Health Care

Other

Collaborators

  • Charite-Institute of Medical Immunology
  • TheWellbeing Services County of Pirkanmaa

Registry information

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Nov 5, 2019
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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