Mental Training for CFS Following EBV Infection in Adolescents

February 14, 2022 updated by: Vegard Wyller, University Hospital, Akershus

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Lørenskog, Akershus, Norway, N-1478
        • Dept. of Pediatrics, Akershus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical activity
Time Frame: 12 weeks
Mean steps/day during 7 consecutive days measured by accelerometer
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma catecholamines
Time Frame: 12 weeks
12 weeks
Plasma catecholamines
Time Frame: 64 weeks
64 weeks
Urine cortisol:creatinin ratio
Time Frame: 12 weeks
12 weeks
Urine cortisol:creatinin ratio
Time Frame: 64 weeks
64 weeks
Degree centrality index of cytokine network
Time Frame: 12 weeks
An index of node centrality, based upon network analyses
12 weeks
Degree centrality index of cytokine network
Time Frame: 64 weeks
An index of node centrality, based upon network analyses
64 weeks
Number of NK-cells
Time Frame: 12 weeks
12 weeks
Number of NK-cells
Time Frame: 64 weeks
64 weeks
Supine heart rate
Time Frame: 12 weeks
12 weeks
Supine heart rate
Time Frame: 64 weeks
64 weeks
Heart rate variability indices
Time Frame: 12 weeks
12 weeks
Heart rate variability indices
Time Frame: 64 weeks
64 weeks
Heart rate, blood pressure and total peripheral resistence responses to upright posture
Time Frame: 12 weeks
12 weeks
Heart rate, blood pressure and total peripheral resistence responses to upright posture
Time Frame: 64 weeks
64 weeks
Working memory
Time Frame: 12 weeks
Digit span forward and backward test
12 weeks
Working memory
Time Frame: 64 weeks
Digit span forward and backward test
64 weeks
Cognitive inhibition
Time Frame: 12 weeks
Color-word interference test from the D-KEFS instrument
12 weeks
Cognitive inhibition
Time Frame: 64 weeks
Color-word interference test from the D-KEFS instrument
64 weeks
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
12 weeks
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
64 weeks
Fatigue score (Chalder fatigue questionnaire)
Time Frame: 12 weeks
12 weeks
Fatigue score (Chalder fatigue questionnaire)
Time Frame: 64 weeks
64 weeks
Pain scores (Brief pain Inventory)
Time Frame: 12 weeks
12 weeks
Pain scores (Brief pain Inventory)
Time Frame: 64 weeks
64 weeks
Quality of Life score (PedsQL)
Time Frame: 12 weeks
12 weeks
Quality of Life score (PedsQL)
Time Frame: 64 weeks
64 weeks
Anxiety and depression score (HADS)
Time Frame: 12 weeks
12 weeks
Anxiety and depression score (HADS)
Time Frame: 64 weeks
64 weeks
Alexithymia score (TAS-20)
Time Frame: 12 weeks
12 weeks
Alexithymia score (TAS-20)
Time Frame: 64 weeks
64 weeks
Insomnia score (KSQ)
Time Frame: 12 weeks
12 weeks
Insomnia score (KSQ)
Time Frame: 64 weeks
64 weeks
Pain threshold (algometry)
Time Frame: 12 weeks
12 weeks
Pain threshold (algometry)
Time Frame: 64 weeks
64 weeks
Disability score (FDI)
Time Frame: 12 weeks
12 weeks
Disability score (FDI)
Time Frame: 64 weeks
64 weeks
Side effect and unexpected events questionnaire
Time Frame: 3 weeks
3 weeks
Side effect and unexpected events questionnaire
Time Frame: 6 weeks
6 weeks
Side effect and unexpected events questionnaire
Time Frame: 9 weeks
9 weeks
Side effect and unexpected events questionnaire
Time Frame: 12 weeks
12 weeks
Physical activity
Time Frame: 64 weeks
Mean steps/day during 7 consecutive days measured by accelerometer
64 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Akershus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vegard Bruun Wyller, PhD, University Hospital, Akershus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEBA part 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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