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A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01806246
Recruitment Status : Completed
First Posted : March 7, 2013
Last Update Posted : October 23, 2015
Information provided by (Responsible Party):
St. Olavs Hospital

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.

Condition or disease Intervention/treatment
Chronic Fatigue Syndrome Behavioral: integrative rehabilitation program

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Integrative Approach Based Psychoeducation, Heart Rate Variability Coherence Biofeedback and Elements of, Pacing Cognitive Behavior Therapy
Study Start Date : February 2013
Primary Completion Date : September 2015
Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. fatigue change [ Time Frame: baseline and 52 weeks ]
    assessed by Fatigue Severity Scale

  2. quality of life change [ Time Frame: baseline and 52 weeks ]
    assessed by Inventory of Life Quality for Children and Adolescents

Secondary Outcome Measures :
  1. mood change [ Time Frame: baseline and 52 weeks ]
    assessed by Mood and Feelings Questionnaire

  2. change in heart rate variability [ Time Frame: baseline and 52 weeks ]
  3. school attendance change [ Time Frame: baseline and 52 weeks ]
  4. general health change [ Time Frame: baseline and 52 weeks ]
    General Health Questionnaire (GHQ-12)

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01806246     History of Changes
Other Study ID Numbers: 2012/2159
First Posted: March 7, 2013    Key Record Dates
Last Update Posted: October 23, 2015
Last Verified: October 2015

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

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