Fatigue Syndrome, ChronicNCT02499302

Mental Training for CFS Following EBV Infection in Adolescents

A study testing Mental training in people with Fatigue Syndrome, Chronic and Epstein-Barr Virus Infection, run by University Hospital, Akershus at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 12 to 20 years
Conditions the study is for: Fatigue Syndrome, Chronic, Epstein-Barr Virus Infection
What is being tested?: Mental training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteNorway
Study dates: Oct 2015to Oct 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 20 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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)

Who cannot join

Other illnesses that might explain the fatigue
Bedridden

Trial locations and contacts

1 site in 1 country.

Norway1 site

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

Other trials in Norway

About this study

Official title: 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).

Read the 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)

Conditions: Fatigue Syndrome, Chronic, Epstein-Barr Virus Infection
Being tested: Mental training
Medical subject headings: Fatigue Syndrome, Chronic, Epstein-Barr Virus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mental trainingBehavioural

Study groups in NCT02499302
Study group	Role	What they receive
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 Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Physical activity
Mean steps/day during 7 consecutive days measured by accelerometer
Measured: 12 weeks

Secondary outcomes (41)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2015Oct 2018

First posted16 Jul 2015 (estimated)
Study startOct 2015
Primary completionOct 2017
Study completionOct 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Fatigue Syndrome, ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02499302
Sponsor's protocol ID: CEBA part 2
Status last verified: Feb 2022
First submitted: 9 Jul 2015
Last updated: 16 Feb 2022
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 33117895
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.
PubMed 32342016

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis

All Fatigue Syndrome, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mental Training for Chronic Fatigue Syndrome (CFS/ME) Following EBV Infection in Adolescents: A Randomised Controlled Trial
ClinicalTrials.gov ID: NCT02499302
Acronym / sponsor ID: CEBA part 2
Conditions: Fatigue Syndrome, Chronic, Epstein-Barr Virus Infection
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University Hospital, AkershusUniversity, hospital or other
Study start: Oct 2015 (actual)
Primary completion: Oct 2017 (actual)
Study completion: Oct 2018 (actual)
First posted: 16 Jul 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Mental training	Experimental	Behavioral: Mental trainingThe 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
Routine follow-up	No intervention	–Routine follow-up by the general practitioner, which is normal approach to chronic fatigue following acute EBV infection.

Who may qualify

Ages: 12 to 20 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (2 listed)

Other illnesses that might explain the fatigue
Bedridden

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mental training	Behavioural	Mental training

Primary outcome

Physical activity
Time frame: 12 weeks
Mean steps/day during 7 consecutive days measured by accelerometer

41 secondary outcomes

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
Degree centrality index of cytokine network
Time frame: 64 weeks
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
Working memory
Time frame: 64 weeks
Cognitive inhibition
Time frame: 12 weeks
Cognitive inhibition
Time frame: 64 weeks
Correlation matrix indices of regions of interests (ROIs) in the brain salience network
Time frame: 12 weeks
Correlation matrix indices of regions of interests (ROIs) in the brain salience network
Time frame: 64 weeks
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
Derived from this study: PubMed 33117895Malik 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.
Derived from this study: PubMed 32342016Malik 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.

Related trials for Fatigue Syndrome, Chronic

Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
Recruiting
ME/CFS Brain Fog: Cognitive Rehabilitation Trial
ME/CFS, ME/CFS Following EBV-associated Infectious Mononucleosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Vegard Bruun Wyller, PhD principal investigator

University Hospital, Akershus

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mental training in people with Fatigue Syndrome, Chronic and Epstein-Barr Virus Infection, run by University Hospital, Akershus at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02499302, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.