The general aim of this study is to investigate the effect of an individually tailored mental training program in adolescents developing chronic fatigue syndrome (CFS) after an acute Epstein Barr-virus (EBV) infection. Endpoints include physical activity (primary endpoint), symptoms (fatigue, pain, insomnia), cognitive function (executive functions) and markers of disease mechanisms (autonomic, endocrine, and immune responses).
EBV-infection is a well-known trigger of CFS. A closely related research project (Chronic fatigue following acute Epstein-Barr virus infection in Adolescents; ClinicalTrials ID:NCT02335437) is a combined prospective and cross-sectional study of 200 adolescents suffering from acute EBV infection. The primary aim of that study is to identify factors that predispose to CFS 6 months after the acute infection. Thus, that project will provide a sample of thoroughly characterized CFS patients, all having the same precipitation factor (EBV-infection). The present project is an intervention trial in the subgroup of patients that actually did develop CFS 6 months after the acute EBV infection. Patients will be randomised 1:1 to either a mental training program (10 sessions) combining elements from cognitive behavioral therapy and music therapy, or routine follow-up from the general practitioner. By its nature, treatment group allocation cannot be blinded; however, both patients and therapists will be blinded for end-point evaluation. An extensive investigational program will be carried out at three time points: Prior to the intervention, immediately after the intervention, and 1 year after the intervention. The program includes: Clinical examination; Pain threshold assessment; Cardiovascular assessment; Cognitive assessment; Sampling of biological material (blood and urine); Questionnaire; Brain fMRI; Qualitative interview; Monitoring of physical activity (accelerometer)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Dept. of Pediatrics, Akershus University Hospital
Lørenskog, Akershus, Norway
Physical activity
Mean steps/day during 7 consecutive days measured by accelerometer
Time frame: 12 weeks
Plasma catecholamines
Time frame: 12 weeks
Plasma catecholamines
Time frame: 64 weeks
Urine cortisol:creatinin ratio
Time frame: 12 weeks
Urine cortisol:creatinin ratio
Time frame: 64 weeks
Degree centrality index of cytokine network
An index of node centrality, based upon network analyses
Time frame: 12 weeks
Degree centrality index of cytokine network
An index of node centrality, based upon network analyses
Time frame: 64 weeks
Number of NK-cells
Time frame: 12 weeks
Number of NK-cells
Time frame: 64 weeks
Supine heart rate
Time frame: 12 weeks
Supine heart rate
Time frame: 64 weeks
Heart rate variability indices
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Time frame: 12 weeks
Heart rate variability indices
Time frame: 64 weeks
Heart rate, blood pressure and total peripheral resistence responses to upright posture
Time frame: 12 weeks
Heart rate, blood pressure and total peripheral resistence responses to upright posture
Time frame: 64 weeks
Working memory
Digit span forward and backward test
Time frame: 12 weeks
Working memory
Digit span forward and backward test
Time frame: 64 weeks
Cognitive inhibition
Color-word interference test from the D-KEFS instrument
Time frame: 12 weeks
Cognitive inhibition
Color-word interference test from the D-KEFS instrument
Time frame: 64 weeks
Correlation matrix indices of regions of interests (ROIs) in the brain salience network
Functional connectivity analyses from resting state brain fMRI
Time frame: 12 weeks
Correlation matrix indices of regions of interests (ROIs) in the brain salience network
Functional connectivity analyses from resting state brain fMRI
Time frame: 64 weeks
Fatigue score (Chalder fatigue questionnaire)
Time frame: 12 weeks
Fatigue score (Chalder fatigue questionnaire)
Time frame: 64 weeks
Pain scores (Brief pain Inventory)
Time frame: 12 weeks
Pain scores (Brief pain Inventory)
Time frame: 64 weeks
Quality of Life score (PedsQL)
Time frame: 12 weeks
Quality of Life score (PedsQL)
Time frame: 64 weeks
Anxiety and depression score (HADS)
Time frame: 12 weeks
Anxiety and depression score (HADS)
Time frame: 64 weeks
Alexithymia score (TAS-20)
Time frame: 12 weeks
Alexithymia score (TAS-20)
Time frame: 64 weeks
Insomnia score (KSQ)
Time frame: 12 weeks
Insomnia score (KSQ)
Time frame: 64 weeks
Pain threshold (algometry)
Time frame: 12 weeks
Pain threshold (algometry)
Time frame: 64 weeks
Disability score (FDI)
Time frame: 12 weeks
Disability score (FDI)
Time frame: 64 weeks
Side effect and unexpected events questionnaire
Time frame: 3 weeks
Side effect and unexpected events questionnaire
Time frame: 6 weeks
Side effect and unexpected events questionnaire
Time frame: 9 weeks
Side effect and unexpected events questionnaire
Time frame: 12 weeks
Physical activity
Mean steps/day during 7 consecutive days measured by accelerometer
Time frame: 64 weeks