NCT01806246CompletedNot Applicable
An Integrative Approach Based Psychoeducation, Heart Rate Variability Coherence Biofeedback and Elements of, Pacing Cognitive Behavior Therapy
St. Olavs Hospital1 site in 1 country13 target enrollmentStarted: February 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- fatigue change
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 13 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •serious comorbidity such as anorexia, psychosis
- •serious depression
Outcomes
Primary Outcomes
fatigue change
Time Frame: baseline and 52 weeks
assessed by Fatigue Severity Scale
quality of life change
Time Frame: baseline and 52 weeks
assessed by Inventory of Life Quality for Children and Adolescents
Secondary Outcomes
- change in heart rate variability(baseline and 52 weeks)
- school attendance change(baseline and 52 weeks)
- mood change(baseline and 52 weeks)
- general health change(baseline and 52 weeks)
Investigators
Study Sites (1)
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