A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome
An Integrative Approach Based Psychoeducation, Heart Rate Variability Coherence Biofeedback and Elements of, Pacing Cognitive Behavior Therapy
1 other identifier
interventional
13
1 country
1
Brief Summary
The aim of the programme is to develop a treatment model for adolescents with Chronic Fatigue Syndrome. The program consists of 4 elements lasting for 12 months, psychoeducation reflecting the current knowledge about the disease, Heart Rate Variability Coherence Biofeedback, pacing and activity planning and some principles of cognitive behaviour therapy. The study is designed as a Single-Case study including 10- 15 participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 1, 2013
CompletedFirst Posted
Study publicly available on registry
March 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 23, 2015
October 1, 2015
2.6 years
March 1, 2013
October 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
fatigue change
assessed by Fatigue Severity Scale
baseline and 52 weeks
quality of life change
assessed by Inventory of Life Quality for Children and Adolescents
baseline and 52 weeks
Secondary Outcomes (4)
mood change
baseline and 52 weeks
change in heart rate variability
baseline and 52 weeks
school attendance change
baseline and 52 weeks
general health change
baseline and 52 weeks
Study Arms (1)
integrative rehabilitation program
EXPERIMENTAL28 sessions during 12 months with focus on psychoeducation, activity planning, and thoughts and feelings connected to having a serious chronic disease. From week 13 to week 32 a training programme aiming at balancing heart rate variability.
Interventions
Eligibility Criteria
You may qualify if:
- Participants who meet the diagnostic criteria of chronic fatigue syndrome
- Clinically evaluated, exclude any disease that can explain the chronic fatigue;
- Diagnosed and evaluated within the health region, Central Norway
- With written consent form signed by themselves and their parents.
You may not qualify if:
- serious comorbidity such as anorexia, psychosis
- serious depression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept Child and Adolescent Psychiatry, St Olavs Hospital
Trondheim, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thomas Jozefiak, md phd
St. Olavs Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2013
First Posted
March 7, 2013
Study Start
February 1, 2013
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 23, 2015
Record last verified: 2015-10