Clinical Trial: Mental Training for CFS Following EBV Infection in Adolescents

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Mental Training for Chronic Fatigue Syndrome (CFS/ME) Following EBV Infection in Adolescents: A Randomised Controlled Trial

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 Summary:

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)


Sponsor: University Hospital, Akershus

Current Primary Outcome: Physical activity [ Time Frame: 12 weeks ]

Mean steps/day during 7 consecutive days measured by accelerometer


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Plasma catecholamines [ Time Frame: 12 weeks ]
  • Plasma catecholamines [ Time Frame: 64 weeks ]
  • Urine cortisol:creatinin ratio [ Time Frame: 12 weeks ]
  • Urine cortisol:creatinin ratio [ Time Frame: 64 weeks ]
  • Degree centrality index of cytokine network [ Time Frame: 12 weeks ]
    An index of node centrality, based upon network analyses
  • Degree centrality index of cytokine network [ Time Frame: 64 weeks ]
    An index of node centrality, based upon network analyses
  • Number of NK-cells [ Time Frame: 12 weeks ]
  • Number of NK-cells [ Time Frame: 64 weeks ]
  • Supine heart rate [ Time Frame: 12 weeks ]
  • Supine heart rate [ Time Frame: 64 weeks ]
  • Heart rate variability indices [ Time Frame: 12 weeks ]
  • Heart rate variability indices [ Time Frame: 64 weeks ]
  • Heart rate, blood pressure and total peripheral resistence responses to upright posture [ Time Frame: 12 weeks ]
  • Heart rate, blood pressure and total peripheral resistence responses to upright posture [ Time Frame: 64 weeks ]
  • Working memory [ Time Frame: 12 weeks ]
    Digit span forward and backward test
  • Working memory [ Time Frame: 64 weeks ]
    Digit span forward and backward test
  • Cognitive inhibition [ Time Frame: 12 weeks ]
    Color-word interference test from the D-KEFS instrument
  • Cognitive inhibition [ Time Frame: 64 weeks ]
    Color-word interference test from the D-KEFS instrument
  • Correlation matrix indices of regions of interests (ROIs) in the brain salience network [ Time Frame: 12 weeks ]
    Functional connectivity analyses from resting state brain fMRI
  • Correlation matrix indices of regions of interests (ROIs) in the brain salience network [ Time Frame: 64 weeks ]
    Functional connectivity analyses from resting state brain fMRI
  • Fatigue score (Chalder fatigue questionnaire) [ Time Frame: 12 weeks ]
  • Fatigue score (Chalder fatigue questionnaire) [ Time Frame: 64 weeks ]
  • Pain scores (Brief pain Inventory) [ Time Frame: 12 weeks ]
  • Pain scores (Brief pain Inventory) [ Time Frame: 64 weeks ]
  • Quality of Life score (PedsQL) [ Time Frame: 12 weeks ]
  • Quality of Life score (PedsQL) [ Time Frame: 64 weeks ]
  • Anxiety and depression score (HADS) [ Time Frame: 12 weeks ]
  • Anxiety and depression score (HADS) [ Time Frame: 64 weeks ]
  • Alexithymia score (TAS-20) [ Time Frame: 12 weeks ]
  • Alexithymia score (TAS-20) [ Time Frame: 64 weeks ]
  • Insomnia score (KSQ) [ Time Frame: 12 weeks ]
  • Insomnia score (KSQ) [ Time Frame: 64 weeks ]
  • Pain threshold (algometry) [ Time Frame: 12 weeks ]
  • Pain threshold (algometry) [ Time Frame: 64 weeks ]
  • Disability score (FDI) [ Time Frame: 12 weeks ]
  • Disability score (FDI) [ Time Frame: 64 weeks ]
  • Side effect and unexpected events questionnaire [ Time Frame: 3 weeks ]
  • Side effect and unexpected events questionnaire [ Time Frame: 6 weeks ]
  • Side effect and unexpected events questionnaire [ Time Frame: 9 weeks ]
  • Side effect and unexpected events questionnaire [ Time Frame: 12 weeks ]
  • Physical activity [ Time Frame: 64 weeks ]
    Mean steps/day during 7 consecutive days measured by accelerometer


Original Secondary Outcome: Same as current

Information By: University Hospital, Akershus

Dates:
Date Received: July 9, 2015
Date Started: October 2015
Date Completion: April 2018
Last Updated: April 8, 2016
Last Verified: April 2016