Mental Training for Chronic Fatigue Syndrome (CFS/ME) Following EBV Infection in Adolescents: A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Physical activity
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Routine follow-up
Routine follow-up by the general practitioner, which is normal approach to chronic fatigue following acute EBV infection.
Mental training
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:
- Psychoeducation: Theories of CFS/ME pathophysiology and treatment rationale
- Relaxation: Bodily stress reduction, mindfulness
- Visualization: Contact with positive emotions, techniques of worrying reduction
- Experiences: Behavioral 'experiments' (individually adjusted), 'trick into action'
- Cognitive challenges: Challenging thoughts about disease process, stimulus and outcome expectancies, prognosis
Intervention: Mental training (Behavioral)
Outcomes
Primary Outcomes
Physical activity
Time Frame: 12 weeks
Mean steps/day during 7 consecutive days measured by accelerometer
Secondary Outcomes
- Number of NK-cells(64 weeks)
- Supine heart rate(64 weeks)
- Heart rate variability indices(64 weeks)
- Plasma catecholamines(64 weeks)
- Degree centrality index of cytokine network(64 weeks)
- Working memory(64 weeks)
- Cognitive inhibition(64 weeks)
- Insomnia score (KSQ)(64 weeks)
- Urine cortisol:creatinin ratio(64 weeks)
- Heart rate, blood pressure and total peripheral resistence responses to upright posture(64 weeks)
- Pain scores (Brief pain Inventory)(64 weeks)
- Pain threshold (algometry)(64 weeks)
- Disability score (FDI)(64 weeks)
- Fatigue score (Chalder fatigue questionnaire)(64 weeks)
- Quality of Life score (PedsQL)(64 weeks)
- Alexithymia score (TAS-20)(64 weeks)
- Correlation matrix indices of regions of interests (ROIs) in the brain salience network(64 weeks)
- Physical activity(64 weeks)
- Anxiety and depression score (HADS)(64 weeks)
- Side effect and unexpected events questionnaire(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)
- Side effect and unexpected events questionnaire(6 weeks)
- Side effect and unexpected events questionnaire(9 weeks)
- Working memory(12 weeks)
- Cognitive inhibition(12 weeks)
- Heart rate, blood pressure and total peripheral resistence responses to upright posture(12 weeks)
- Plasma catecholamines(12 weeks)
- Urine cortisol:creatinin ratio(12 weeks)
- Degree centrality index of cytokine network(12 weeks)
- Number of NK-cells(12 weeks)
- Supine heart rate(12 weeks)
- Heart rate variability indices(12 weeks)
- Correlation matrix indices of regions of interests (ROIs) in the brain salience network(12 weeks)
- Fatigue score (Chalder fatigue questionnaire)(12 weeks)
- Pain scores (Brief pain Inventory)(12 weeks)
- Quality of Life score (PedsQL)(12 weeks)
- Anxiety and depression score (HADS)(12 weeks)
Investigators
Vegard Wyller
Professor
University Hospital, Akershus