Mental Training for CFS Following EBV Infection in Adolescents

University Hospital, Akershus

Status: Completed

Conditions: Fatigue Syndrome, Chronic; Epstein-Barr Virus Infection

Treatments: Behavioral: Mental training

Study type: Interventional

Funder types: Other

Identifiers

NCT02499302

CEBA part 2

Details and patient eligibility

About

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).

Full 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)

Enrollment: 50 patients

Sex: All

Ages: 12 to 20 years old

Volunteers: No 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)

Exclusion criteria

• Other illnesses that might explain the fatigue
• Bedridden

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Mental training

Experimental group

Description:

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

Treatment:

Behavioral: Mental training

Routine follow-up

No Intervention group

Description:

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