Mental Training for CFS Following EBV Infection in Adolescents

Sponsor

University Hospital, Akershus (Other)

Overall Status

Completed

CT.gov ID

NCT02499302

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Oct 1, 2015

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Physical activity [12 weeks]
Mean steps/day during 7 consecutive days measured by accelerometer

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)