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Clinical Trials/NCT01806246
NCT01806246
Completed
Not 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 enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Fatigue Syndrome
Sponsor
St. Olavs Hospital
Enrollment
13
Locations
1
Primary Endpoint
fatigue change
Status
Completed
Last Updated
10 years ago

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
September 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
St. Olavs Hospital
Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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