Clinical trial NCT02499302: Mental Training for CFS Following EBV Infection in Adolescents
Official title: Mental Training for Chronic Fatigue Syndrome (CFS/ME) Following EBV Infection in Adolescents: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue Syndrome, Chronic
Epstein-Barr Virus Infection
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Physical activity
timeFrame: 12 weeks
Secondary outcomes:
measure: Plasma catecholamines
timeFrame: 12 weeks
measure: Plasma catecholamines
timeFrame: 64 weeks
measure: Urine cortisol:creatinin ratio
timeFrame: 12 weeks
measure: Urine cortisol:creatinin ratio
timeFrame: 64 weeks
measure: Degree centrality index of cytokine network
timeFrame: 12 weeks
measure: Degree centrality index of cytokine network
timeFrame: 64 weeks
measure: Number of NK-cells
timeFrame: 12 weeks
measure: Number of NK-cells
timeFrame: 64 weeks
measure: Supine heart rate
timeFrame: 12 weeks
measure: Supine heart rate
timeFrame: 64 weeks
measure: Heart rate variability indices
timeFrame: 12 weeks
measure: Heart rate variability indices
timeFrame: 64 weeks
measure: Heart rate, blood pressure and total peripheral resistence responses to upright posture
timeFrame: 12 weeks
measure: Heart rate, blood pressure and total peripheral resistence responses to upright posture
timeFrame: 64 weeks
measure: Working memory
timeFrame: 12 weeks
measure: Working memory
timeFrame: 64 weeks
measure: Cognitive inhibition
timeFrame: 12 weeks
measure: Cognitive inhibition
timeFrame: 64 weeks
measure: Correlation matrix indices of regions of interests (ROIs) in the brain salience network
timeFrame: 12 weeks
measure: Correlation matrix indices of regions of interests (ROIs) in the brain salience network
timeFrame: 64 weeks
measure: Fatigue score (Chalder fatigue questionnaire)
timeFrame: 12 weeks
measure: Fatigue score (Chalder fatigue questionnaire)
timeFrame: 64 weeks
measure: Pain scores (Brief pain Inventory)
timeFrame: 12 weeks
measure: Pain scores (Brief pain Inventory)
timeFrame: 64 weeks
measure: Quality of Life score (PedsQL)
timeFrame: 12 weeks
measure: Quality of Life score (PedsQL)
timeFrame: 64 weeks
measure: Anxiety and depression score (HADS)
timeFrame: 12 weeks
measure: Anxiety and depression score (HADS)
timeFrame: 64 weeks
measure: Alexithymia score (TAS-20)
timeFrame: 12 weeks
measure: Alexithymia score (TAS-20)
timeFrame: 64 weeks
measure: Insomnia score (KSQ)
timeFrame: 12 weeks
measure: Insomnia score (KSQ)
timeFrame: 64 weeks
measure: Pain threshold (algometry)
timeFrame: 12 weeks
measure: Pain threshold (algometry)
timeFrame: 64 weeks
measure: Disability score (FDI)
timeFrame: 12 weeks
measure: Disability score (FDI)
timeFrame: 64 weeks
measure: Side effect and unexpected events questionnaire
timeFrame: 3 weeks
measure: Side effect and unexpected events questionnaire
timeFrame: 6 weeks
measure: Side effect and unexpected events questionnaire
timeFrame: 9 weeks
measure: Side effect and unexpected events questionnaire
timeFrame: 12 weeks
measure: Physical activity
timeFrame: 64 weeks
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Dept. of Pediatrics, Akershus University Hospital
state: Akershus
Study officials:
affiliation: University Hospital, Akershus
name: Vegard Bruun Wyller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.