Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Mental Training for CFS Following EBV Infection in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02499302
Recruitment Status : Active, not recruiting
First Posted : July 16, 2015
Last Update Posted : January 10, 2018
Sponsor:
Information provided by (Responsible Party):
Vegard Bruun Wyller, MD, PhD, 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).

Condition or disease Intervention/treatment Phase
Fatigue Syndrome, Chronic Epstein-Barr Virus Infection Behavioral: Mental training Not Applicable

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)


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mental Training for Chronic Fatigue Syndrome (CFS/ME) Following EBV Infection in Adolescents: A Randomised Controlled Trial
Actual Study Start Date : October 2015
Actual Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Behavioral: Mental training
No Intervention: Routine follow-up
Routine follow-up by the general practitioner, which is normal approach to chronic fatigue following acute EBV infection.



Primary Outcome Measures :
  1. Physical activity [ Time Frame: 12 weeks ]
    Mean steps/day during 7 consecutive days measured by accelerometer


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499302


Locations
Layout table for location information
Norway
Dept. of Pediatrics, Akershus University Hospital
Lørenskog, Akershus, Norway, N-1478
Sponsors and Collaborators
University Hospital, Akershus
Investigators
Layout table for investigator information
Principal Investigator: Vegard Bruun Wyller, PhD University Hospital, Akershus

Layout table for additonal information
Responsible Party: Vegard Bruun Wyller, MD, PhD, Professor, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT02499302     History of Changes
Other Study ID Numbers: CEBA part 2
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
Fatigue Syndrome, Chronic
Syndrome
Fatigue
Infection
Communicable Diseases
Epstein-Barr Virus Infections
Virus Diseases
Disease
Pathologic Processes
Signs and Symptoms
Herpesviridae Infections
DNA Virus Infections
Tumor Virus Infections
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases