Mental Training for CFS Following EBV Infection in Adolescents

Not Applicable

Completed

• Conditions: Epstein-Barr Virus Infection; Fatigue Syndrome, Chronic
• Interventions: Behavioral: Mental training

• Registration Number: NCT02499302
• Lead Sponsor: University Hospital, Akershus

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 Timeline

• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Study Start: 2015-10
• Primary Completion: 2017-10
• Study Completion: 2018-10
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mental training	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

Primary Outcome Measures

Name	Time	Method
Physical activity	12 weeks	Mean steps/day during 7 consecutive days measured by accelerometer

Secondary Outcome Measures

Name	Time	Method
Plasma catecholamines	64 weeks
Urine cortisol:creatinin ratio	64 weeks
Fatigue score (Chalder fatigue questionnaire)	64 weeks
Heart rate, blood pressure and total peripheral resistence responses to upright posture	64 weeks
Number of NK-cells	64 weeks
Heart rate variability indices	64 weeks
Degree centrality index of cytokine network	64 weeks	An index of node centrality, based upon network analyses
Working memory	64 weeks	Digit span forward and backward test
Cognitive inhibition	64 weeks	Color-word interference test from the D-KEFS instrument
Insomnia score (KSQ)	64 weeks
Supine heart rate	64 weeks
Pain scores (Brief pain Inventory)	64 weeks
Pain threshold (algometry)	64 weeks
Disability score (FDI)	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	Functional connectivity analyses from resting state brain fMRI
Physical activity	64 weeks	Mean steps/day during 7 consecutive days measured by accelerometer
Anxiety and depression score (HADS)	64 weeks
Side effect and unexpected events questionnaire	12 weeks

Trial Locations

Locations (1)

Dept. of Pediatrics, Akershus University Hospital; 🇳🇴 Lørenskog, Akershus, Norway