NCT02499302

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 16, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

July 9, 2015

Last Update Submit

February 14, 2022

Conditions

Fatigue Syndrome, ChronicEpstein-Barr Virus Infection

Outcome Measures

Primary Outcomes (1)

  • Physical activity

    Mean steps/day during 7 consecutive days measured by accelerometer

    12 weeks

Secondary Outcomes (41)

  • Plasma catecholamines

    12 weeks

  • Plasma catecholamines

    64 weeks

  • Urine cortisol:creatinin ratio

    12 weeks

  • Urine cortisol:creatinin ratio

    64 weeks

  • Degree centrality index of cytokine network

    12 weeks

  • +36 more secondary outcomes

Study Arms (2)

Mental training

EXPERIMENTAL

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

Routine follow-up

NO INTERVENTION

Routine follow-up by the general practitioner, which is normal approach to chronic fatigue following acute EBV infection.

Interventions

Mental trainingBEHAVIORAL
Mental training

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Other illnesses that might explain the fatigue
  • Bedridden

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Pediatrics, Akershus University Hospital

Lørenskog, Akershus, N-1478, Norway

Location

Related Publications (2)

  • Malik S, Asprusten TT, Pedersen M, Mangersnes J, Trondalen G, van Roy B, Skovlund E, Wyller VB. Cognitive-behavioural therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a randomised controlled trial. BMJ Paediatr Open. 2020 Oct 21;4(1):e000797. doi: 10.1136/bmjpo-2020-000797. eCollection 2020.

    PMID: 33117895DERIVED

  • Malik S, Asprusten TT, Pedersen M, Mangersnes J, Trondalen G, van Roy B, Skovlund E, Wyller VB. Cognitive-behavioural therapy combined with music therapy for chronic fatigue following Epstein-Barr virus infection in adolescents: a feasibility study. BMJ Paediatr Open. 2020 Apr 9;4(1):e000620. doi: 10.1136/bmjpo-2019-000620. eCollection 2020.

    PMID: 32342016DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, ChronicEpstein-Barr Virus Infections

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus Infections

Study Officials

  • Vegard Bruun Wyller, PhD

    University Hospital, Akershus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 16, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2018

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations

NO(1)