Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-04 @ 9:37 AM
Study NCT ID:
NCT02499302
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2015-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mental Training for CFS Following EBV Infection in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2015-07-09', 'studyFirstSubmitQcDate': '2015-07-14', 'lastUpdatePostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physical activity', 'timeFrame': '12 weeks', 'description': 'Mean steps/day during 7 consecutive days measured by accelerometer'}], 'secondaryOutcomes': [{'measure': 'Plasma catecholamines', 'timeFrame': '12 weeks'}, {'measure': 'Plasma catecholamines', 'timeFrame': '64 weeks'}, {'measure': 'Urine cortisol:creatinin ratio', 'timeFrame': '12 weeks'}, {'measure': 'Urine cortisol:creatinin ratio', 'timeFrame': '64 weeks'}, {'measure': 'Degree centrality index of cytokine network', 'timeFrame': '12 weeks', 'description': 'An index of node centrality, based upon network analyses'}, {'measure': 'Degree centrality index of cytokine network', 'timeFrame': '64 weeks', 'description': 'An index of node centrality, based upon network analyses'}, {'measure': 'Number of NK-cells', 'timeFrame': '12 weeks'}, {'measure': 'Number of NK-cells', 'timeFrame': '64 weeks'}, {'measure': 'Supine heart rate', 'timeFrame': '12 weeks'}, {'measure': 'Supine heart rate', 'timeFrame': '64 weeks'}, {'measure': 'Heart rate variability indices', 'timeFrame': '12 weeks'}, {'measure': 'Heart rate variability indices', 'timeFrame': '64 weeks'}, {'measure': 'Heart rate, blood pressure and total peripheral resistence responses to upright posture', 'timeFrame': '12 weeks'}, {'measure': 'Heart rate, blood pressure and total peripheral resistence responses to upright posture', 'timeFrame': '64 weeks'}, {'measure': 'Working memory', 'timeFrame': '12 weeks', 'description': 'Digit span forward and backward test'}, {'measure': 'Working memory', 'timeFrame': '64 weeks', 'description': 'Digit span forward and backward test'}, {'measure': 'Cognitive inhibition', 'timeFrame': '12 weeks', 'description': 'Color-word interference test from the D-KEFS instrument'}, {'measure': 'Cognitive inhibition', 'timeFrame': '64 weeks', 'description': 'Color-word interference test from the D-KEFS instrument'}, {'measure': 'Correlation matrix indices of regions of interests (ROIs) in the brain salience network', 'timeFrame': '12 weeks', 'description': 'Functional connectivity analyses from resting state brain fMRI'}, {'measure': 'Correlation matrix indices of regions of interests (ROIs) in the brain salience network', 'timeFrame': '64 weeks', 'description': 'Functional connectivity analyses from resting state brain fMRI'}, {'measure': 'Fatigue score (Chalder fatigue questionnaire)', 'timeFrame': '12 weeks'}, {'measure': 'Fatigue score (Chalder fatigue questionnaire)', 'timeFrame': '64 weeks'}, {'measure': 'Pain scores (Brief pain Inventory)', 'timeFrame': '12 weeks'}, {'measure': 'Pain scores (Brief pain Inventory)', 'timeFrame': '64 weeks'}, {'measure': 'Quality of Life score (PedsQL)', 'timeFrame': '12 weeks'}, {'measure': 'Quality of Life score (PedsQL)', 'timeFrame': '64 weeks'}, {'measure': 'Anxiety and depression score (HADS)', 'timeFrame': '12 weeks'}, {'measure': 'Anxiety and depression score (HADS)', 'timeFrame': '64 weeks'}, {'measure': 'Alexithymia score (TAS-20)', 'timeFrame': '12 weeks'}, {'measure': 'Alexithymia score (TAS-20)', 'timeFrame': '64 weeks'}, {'measure': 'Insomnia score (KSQ)', 'timeFrame': '12 weeks'}, {'measure': 'Insomnia score (KSQ)', 'timeFrame': '64 weeks'}, {'measure': 'Pain threshold (algometry)', 'timeFrame': '12 weeks'}, {'measure': 'Pain threshold (algometry)', 'timeFrame': '64 weeks'}, {'measure': 'Disability score (FDI)', 'timeFrame': '12 weeks'}, {'measure': 'Disability score (FDI)', 'timeFrame': '64 weeks'}, {'measure': 'Side effect and unexpected events questionnaire', 'timeFrame': '3 weeks'}, {'measure': 'Side effect and unexpected events questionnaire', 'timeFrame': '6 weeks'}, {'measure': 'Side effect and unexpected events questionnaire', 'timeFrame': '9 weeks'}, {'measure': 'Side effect and unexpected events questionnaire', 'timeFrame': '12 weeks'}, {'measure': 'Physical activity', 'timeFrame': '64 weeks', 'description': 'Mean steps/day during 7 consecutive days measured by accelerometer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Fatigue Syndrome, Chronic', 'Epstein-Barr Virus Infection']}, 'referencesModule': {'references': [{'pmid': '33117895', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32342016', 'type': 'DERIVED', 'citation': '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.', 'retractions': [{'pmid': '33123631', 'source': 'BMJ Paediatr Open. 2020 Oct 21;4(1):e000620ret'}]}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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).\n\nThe 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)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant in the research project CEBA (Chronic fatigue following acute Epstein-Barr virus infection in adolescents, NCT02335437)\n* Chronic fatigue at 6 months (a sum score of dichotomized responses ≥ 4 on the Chalder Fatigue questionnaire)\n\nExclusion Criteria:\n\n* Other illnesses that might explain the fatigue\n* Bedridden'}, 'identificationModule': {'nctId': 'NCT02499302', 'briefTitle': 'Mental Training for CFS Following EBV Infection in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Mental Training for Chronic Fatigue Syndrome (CFS/ME) Following EBV Infection in Adolescents: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'CEBA part 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mental training', '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:\n\n* Psychoeducation: Theories of CFS/ME pathophysiology and treatment rationale\n* Relaxation: Bodily stress reduction, mindfulness\n* Visualization: Contact with positive emotions, techniques of worrying reduction\n* Experiences: Behavioral 'experiments' (individually adjusted), 'trick into action'\n* Cognitive challenges: Challenging thoughts about disease process, stimulus and outcome expectancies, prognosis", 'interventionNames': ['Behavioral: Mental training']}, {'type': 'NO_INTERVENTION', 'label': 'Routine follow-up', 'description': 'Routine follow-up by the general practitioner, which is normal approach to chronic fatigue following acute EBV infection.'}], 'interventions': [{'name': 'Mental training', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Mental training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-1478', 'city': 'Lørenskog', 'state': 'Akershus', 'country': 'Norway', 'facility': 'Dept. of Pediatrics, Akershus University Hospital'}], 'overallOfficials': [{'name': 'Vegard Bruun Wyller, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Akershus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Vegard Wyller', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}