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.
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
- Conditions the study is for
- Psychological Adaptation, Cognitive Change, Adaptive Behavior
- What is being tested?
- Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
Finland1 site, 1 recruiting
- Recruiting
Päijät Häme Central Hospital
Lahti
Meeri Keurulainen, MSci, meeri.keurulainen@paijatha.fi
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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) 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.
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
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)
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
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
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
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.
- First posted5 Nov 2019
- Study start30 Nov 2019
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological AdaptationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- TheWellbeing Services County of Pirkanmaa, Charite-Institute of Medical Immunology
- Responsible party
- Sponsor
- Investigators
- Tuomo Nieminen, Study chair, Päijät- Häme Joint Authority for Health and Wellbeing
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