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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mental training | Experimental | The intervention consists of one introductory session (patients and their parents/next-of-kin), followed by 9 individual therapy sessions (one each week) of 1.5 hours duration and related home-work, combining elements from cognitive behavioural therapy and music therapy: Important elements of the mental training program are:
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| Routine follow-up | No Intervention | Routine follow-up by the general practitioner, which is normal approach to chronic fatigue following acute EBV infection. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mental training | Behavioral |
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| Measure | Description | Time Frame |
|---|---|---|
| Physical activity | Mean steps/day during 7 consecutive days measured by accelerometer | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma catecholamines | 12 weeks | |
| Plasma catecholamines | 64 weeks | |
| Urine cortisol:creatinin ratio |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vegard Bruun Wyller, PhD | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. of Pediatrics, Akershus University Hospital | Lørenskog | Akershus | N-1478 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33117895 | Derived | Malik S, Asprusten TT, Pedersen M, Mangersnes J, Trondalen G, van Roy B, Skovlund E, Wyller VB. Cognitive-behavioural therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a randomised controlled trial. BMJ Paediatr Open. 2020 Oct 21;4(1):e000797. doi: 10.1136/bmjpo-2020-000797. eCollection 2020. | |
| 32342016 |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| D020031 | Epstein-Barr Virus Infections |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| 12 weeks |
| Urine cortisol:creatinin ratio | 64 weeks |
| Degree centrality index of cytokine network | An index of node centrality, based upon network analyses | 12 weeks |
| Degree centrality index of cytokine network | An index of node centrality, based upon network analyses | 64 weeks |
| Number of NK-cells | 12 weeks |
| Number of NK-cells | 64 weeks |
| Supine heart rate | 12 weeks |
| Supine heart rate | 64 weeks |
| Heart rate variability indices | 12 weeks |
| Heart rate variability indices | 64 weeks |
| Heart rate, blood pressure and total peripheral resistence responses to upright posture | 12 weeks |
| Heart rate, blood pressure and total peripheral resistence responses to upright posture | 64 weeks |
| Working memory | Digit span forward and backward test | 12 weeks |
| Working memory | Digit span forward and backward test | 64 weeks |
| Cognitive inhibition | Color-word interference test from the D-KEFS instrument | 12 weeks |
| Cognitive inhibition | Color-word interference test from the D-KEFS instrument | 64 weeks |
| Correlation matrix indices of regions of interests (ROIs) in the brain salience network | Functional connectivity analyses from resting state brain fMRI | 12 weeks |
| Correlation matrix indices of regions of interests (ROIs) in the brain salience network | Functional connectivity analyses from resting state brain fMRI | 64 weeks |
| Fatigue score (Chalder fatigue questionnaire) | 12 weeks |
| Fatigue score (Chalder fatigue questionnaire) | 64 weeks |
| Pain scores (Brief pain Inventory) | 12 weeks |
| Pain scores (Brief pain Inventory) | 64 weeks |
| Quality of Life score (PedsQL) | 12 weeks |
| Quality of Life score (PedsQL) | 64 weeks |
| Anxiety and depression score (HADS) | 12 weeks |
| Anxiety and depression score (HADS) | 64 weeks |
| Alexithymia score (TAS-20) | 12 weeks |
| Alexithymia score (TAS-20) | 64 weeks |
| Insomnia score (KSQ) | 12 weeks |
| Insomnia score (KSQ) | 64 weeks |
| Pain threshold (algometry) | 12 weeks |
| Pain threshold (algometry) | 64 weeks |
| Disability score (FDI) | 12 weeks |
| Disability score (FDI) | 64 weeks |
| Side effect and unexpected events questionnaire | 3 weeks |
| Side effect and unexpected events questionnaire | 6 weeks |
| Side effect and unexpected events questionnaire | 9 weeks |
| Side effect and unexpected events questionnaire | 12 weeks |
| Physical activity | Mean steps/day during 7 consecutive days measured by accelerometer | 64 weeks |
| Malik S, Asprusten TT, Pedersen M, Mangersnes J, Trondalen G, van Roy B, Skovlund E, Wyller VB. Cognitive-behavioural therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a feasibility study. BMJ Paediatr Open. 2020 Apr 9;4(1):e000620. doi: 10.1136/bmjpo-2019-000620. eCollection 2020. |
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| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |