Fatigue Syndrome, Chronic, Epstein-Barr Virus Infection
Conditions
Brief summary
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).
Detailed description
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)
Interventions
BEHAVIORALMental training
Sponsors
University Hospital, Akershus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* Participant in the research project CEBA (Chronic fatigue following acute Epstein-Barr virus infection in adolescents, NCT02335437) * Chronic fatigue at 6 months (a sum score of dichotomized responses ≥ 4 on the Chalder Fatigue questionnaire)
Exclusion criteria
* Other illnesses that might explain the fatigue * Bedridden
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity | 12 weeks | Mean steps/day during 7 consecutive days measured by accelerometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine cortisol:creatinin ratio | 12 weeks | — |
| Degree centrality index of cytokine network | 12 weeks | An index of node centrality, based upon network analyses |
| Number of NK-cells | 12 weeks | — |
| Supine heart rate | 12 weeks | — |
| Heart rate variability indices | 12 weeks | — |
| Heart rate, blood pressure and total peripheral resistence responses to upright posture | 12 weeks | — |
| Working memory | 12 weeks | Digit span forward and backward test |
| Cognitive inhibition | 12 weeks | Color-word interference test from the D-KEFS instrument |
| Correlation matrix indices of regions of interests (ROIs) in the brain salience network | 12 weeks | Functional connectivity analyses from resting state brain fMRI |
| Plasma catecholamines | 12 weeks | — |
| Pain scores (Brief pain Inventory) | 12 weeks | — |
| Quality of Life score (PedsQL) | 12 weeks | — |
| Anxiety and depression score (HADS) | 12 weeks | — |
| Alexithymia score (TAS-20) | 12 weeks | — |
| Insomnia score (KSQ) | 12 weeks | — |
| Pain threshold (algometry) | 12 weeks | — |
| Disability score (FDI) | 12 weeks | — |
| Side effect and unexpected events questionnaire | 3 weeks | — |
| Physical activity | 64 weeks | Mean steps/day during 7 consecutive days measured by accelerometer |
| Fatigue score (Chalder fatigue questionnaire) | 12 weeks | — |
Countries
Norway
Outcome results
None listed