Mental Training for CFS Following EBV Infection in Adolescents

Fatigue Syndrome, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499302
• Other study ID #: CEBA part 2
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 2018

Study information

• Verified date: February 2022
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Epstein-Barr Virus Infection
• Epstein-Barr Virus Infections
• Fatigue
• Fatigue Syndrome, Chronic
• Infections
• Syndrome

Intervention

Behavioral:
• Mental training

Locations

Country	Name	City	State
Norway	Dept. of Pediatrics, Akershus University Hospital	Lørenskog	Akershus

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Akershus

Country where clinical trial is conducted

Norway, 

Outcome

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