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

Primary Purpose

Psychological Adaptation, Cognitive Change, Adaptive Behavior

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
Sponsored by
Joint Authority for Päijät-Häme Social and Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Adaptation focused on measuring 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

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • Have an interest to learn about psychological functioning and how to use this knowledge in rehabilitation or everyday life

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

Sites / Locations

  • Päijät Häme Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Research group ME/CFS

Control group ME/CFS

Arm Description

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

Control group 6 sessions in 3 months n=35-40 patients Health, lifestyle and wellbeing counselling (sleep, nutrition, activities in daily life)

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2019
Last Updated
March 28, 2023
Sponsor
Joint Authority for Päijät-Häme Social and Health Care
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1. Study Identification

Unique Protocol Identification Number
NCT04151693
Brief Title
Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
Official Title
Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2019 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joint Authority for Päijät-Häme Social and Health Care

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Research group ME/CFS
Arm Type
Experimental
Arm Description
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
Arm Title
Control group ME/CFS
Arm Type
Experimental
Arm Description
Control group 6 sessions in 3 months n=35-40 patients Health, lifestyle and wellbeing counselling (sleep, nutrition, activities in daily life)
Intervention Type
Behavioral
Intervention Name(s)
Health Psychological Group Rehabilitation for Patients With Chronic Fatigue Syndrome (ME/CFS)
Intervention Description
Adaptation (support own agency), rehabilitation and improvement of functional capacity.
Primary Outcome Measure Information:
Title
WHODAS 22.0 (World Health Organization Disability Assessment Schedule) 2.0.
Description
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
Time Frame
Before intervention and change immediately after the intervention and 3 months follow up
Title
COMPASS31
Description
Autonomic nervous system/ neurological symptoms, inventory,31 questions. Subscales: different neurological symptoms, scales from 0-1 to 0-7. Score is reported on subscales.
Time Frame
Before intervention and change immediately after the intervention and 3 months follow up
Secondary Outcome Measure Information:
Title
HADS (Hospital Anxiety and Depression Scale)
Description
Depression and anxiety, inventory,14 questions, scale 0-3. Total score is reported (0-7:normal- 8-10:borderline-11-21:abnormal)
Time Frame
Before intervention and change immediately after the intervention and 3 months follow up
Title
SOC-14 (Sense Of Coherence)
Description
Sense of coherence, inventory, 14 questions, scale 0-7. Total score is reported/ scores are reported on subscales: (comprehensibility, manageability, meaningfulness)
Time Frame
Before intervention and change immediately after the intervention and 3 months follow up
Title
FSS (Fatigue severity scale)
Description
Fatigue severity scale,9 questions, scale 0-7 (I strongly disagree- I strongly agree) total score is reported.
Time Frame
Before intervention and change immediately after the intervention and 3 months follow up
Title
PHQ-4 (patient health questionnaire)
Description
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)
Time Frame
Before intervention and change immediately after the intervention and 3 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Have an interest to learn about psychological functioning and how to use this knowledge in rehabilitation or everyday life 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jukka Hintikka, professor
Phone
+358447195119
Email
jukka.hintikka@phhyky.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Meeri Keurulainen, phd student
Phone
+358447195045
Email
meeri.keurulainen@phhyky.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuomo Nieminen, professor
Organizational Affiliation
Päijät- Häme Joint Authority for Health and Wellbeing
Official's Role
Study Chair
Facility Information:
Facility Name
Päijät Häme Central Hospital
City
Lahti
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meeri Keurulainen, MSci
Email
meeri.keurulainen@phhyky.fi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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