A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome

This study has been completed.
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
First received: March 1, 2013
Last updated: October 22, 2015
Last verified: October 2015
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.

Condition Intervention
Chronic Fatigue Syndrome
Behavioral: integrative rehabilitation program

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Integrative Approach Based Psychoeducation, Heart Rate Variability Coherence Biofeedback and Elements of, Pacing Cognitive Behavior Therapy

Resource links provided by NLM:

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • fatigue change [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
    assessed by Fatigue Severity Scale

  • quality of life change [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
    assessed by Inventory of Life Quality for Children and Adolescents

Secondary Outcome Measures:
  • mood change [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
    assessed by Mood and Feelings Questionnaire

  • change in heart rate variability [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
  • school attendance change [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
  • general health change [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
    General Health Questionnaire (GHQ-12)

Enrollment: 13
Study Start Date: February 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: integrative rehabilitation program
28 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.
Behavioral: integrative rehabilitation program


Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01806246

Dept Child and Adolescent Psychiatry, St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
St. Olavs Hospital
Study Director: Thomas Jozefiak, md phd St. Olavs Hospital
  More Information

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01806246     History of Changes
Other Study ID Numbers: 2012/2159
Study First Received: March 1, 2013
Last Updated: October 22, 2015
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by St. Olavs Hospital:
heart rate variability biofeedback

Additional relevant MeSH terms:
Fatigue Syndrome, Chronic
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Virus Diseases

ClinicalTrials.gov processed this record on November 30, 2015