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Psychological AdaptationNCT04151693

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

A study testing Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS) in people with Psychological Adaptation and Cognitive Change, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteFinland
Study dates
30 Nov 2019to 31 May 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
Show all 17Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Suoma Saarni, professor contact

+358440773073

suoma.saarni@paijatha.fi

Meeri Keurulainen, phd student contact

+358447195045

meeri.keurulainen@paijatha.fi

Finland1 site, 1 recruiting

  • Päijät Häme Central Hospital

    Lahti

    Meeri Keurulainen, MSci, meeri.keurulainen@paijatha.fi

    Recruiting

Other trials in Finland

About this study

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.

Read more

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.

Read the 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.
Being tested
Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
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
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT04151693
Study groupRoleWhat they receive
Research group ME/CFSExperimentalHealth 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
Receives: Behavioral: Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
Control group ME/CFSExperimentalControl group 6 sessions in 3 months n=35-40 patients Health, lifestyle and wellbeing counselling (sleep, nutrition, activities in daily life)
Receives: Behavioral: Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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.

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

Secondary outcomes (4)

  1. 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)

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

  2. 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)

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

  3. FSS (Fatigue severity scale)

    Fatigue severity scale,9 questions, scale 0-7 (I strongly disagree- I strongly agree) total score is reported.

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

  4. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2019
  2. Study start30 Nov 2019
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Masking
Single blind
Who is masked
Care provider
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04151693
Sponsor's protocol ID
D/1964/13.00.00.00/2019 Q 028
Status last verified
Apr 2024
First submitted
24 Sep 2019
Last updated
3 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37528544

Questions about this trial

What is this clinical trial studying?

A study testing Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS) in people with Psychological Adaptation and Cognitive Change, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Suoma Saarni, professor (+358440773073, suoma.saarni@paijatha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04151693, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.

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