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Completed

NCT Number: NCT02499302

Mental Training for CFS Following EBV Infection in Adolescents

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).

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Key information

Conditions

Fatigue Syndrome, Chronic Chronic Disease DNA Virus Infections Disease Attributes Encephalomyelitis Epstein-Barr Virus Infection Epstein-Barr Virus Infections Herpesviridae Infections Infections Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tumor Virus Infections Virus Diseases

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Pediatrics, Akershus University Hospital

Lørenskog, Akershus, N-1478, Norway

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mental training

Behavioral

Primary outcomes

  1. Physical activity

    Time frame: 12 weeks

    Mean steps/day during 7 consecutive days measured by accelerometer

Secondary outcomes

  1. Plasma catecholamines

    Time frame: 12 weeks

  2. Plasma catecholamines

    Time frame: 64 weeks

  3. Urine cortisol:creatinin ratio

    Time frame: 12 weeks

  4. Urine cortisol:creatinin ratio

    Time frame: 64 weeks

  5. Degree centrality index of cytokine network

    Time frame: 12 weeks

    An index of node centrality, based upon network analyses

  6. Degree centrality index of cytokine network

    Time frame: 64 weeks

    An index of node centrality, based upon network analyses

  7. Number of NK-cells

    Time frame: 12 weeks

  8. Number of NK-cells

    Time frame: 64 weeks

  9. Supine heart rate

    Time frame: 12 weeks

  10. Supine heart rate

    Time frame: 64 weeks

  11. Heart rate variability indices

    Time frame: 12 weeks

  12. Heart rate variability indices

    Time frame: 64 weeks

  13. Heart rate, blood pressure and total peripheral resistence responses to upright posture

    Time frame: 12 weeks

  14. Heart rate, blood pressure and total peripheral resistence responses to upright posture

    Time frame: 64 weeks

  15. Working memory

    Time frame: 12 weeks

    Digit span forward and backward test

  16. Working memory

    Time frame: 64 weeks

    Digit span forward and backward test

  17. Cognitive inhibition

    Time frame: 12 weeks

    Color-word interference test from the D-KEFS instrument

  18. Cognitive inhibition

    Time frame: 64 weeks

    Color-word interference test from the D-KEFS instrument

  19. 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

  20. 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

  21. Fatigue score (Chalder fatigue questionnaire)

    Time frame: 12 weeks

  22. Fatigue score (Chalder fatigue questionnaire)

    Time frame: 64 weeks

  23. Pain scores (Brief pain Inventory)

    Time frame: 12 weeks

  24. Pain scores (Brief pain Inventory)

    Time frame: 64 weeks

  25. Quality of Life score (PedsQL)

    Time frame: 12 weeks

  26. Quality of Life score (PedsQL)

    Time frame: 64 weeks

  27. Anxiety and depression score (HADS)

    Time frame: 12 weeks

  28. Anxiety and depression score (HADS)

    Time frame: 64 weeks

  29. Alexithymia score (TAS-20)

    Time frame: 12 weeks

  30. Alexithymia score (TAS-20)

    Time frame: 64 weeks

  31. Insomnia score (KSQ)

    Time frame: 12 weeks

  32. Insomnia score (KSQ)

    Time frame: 64 weeks

  33. Pain threshold (algometry)

    Time frame: 12 weeks

  34. Pain threshold (algometry)

    Time frame: 64 weeks

  35. Disability score (FDI)

    Time frame: 12 weeks

  36. Disability score (FDI)

    Time frame: 64 weeks

  37. Side effect and unexpected events questionnaire

    Time frame: 3 weeks

  38. Side effect and unexpected events questionnaire

    Time frame: 6 weeks

  39. Side effect and unexpected events questionnaire

    Time frame: 9 weeks

  40. Side effect and unexpected events questionnaire

    Time frame: 12 weeks

  41. Physical activity

    Time frame: 64 weeks

    Mean steps/day during 7 consecutive days measured by accelerometer

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jul 16, 2015
Registry last updated
Feb 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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