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A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01806246
First Posted: March 7, 2013
Last Update Posted: October 23, 2015
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.
Information provided by (Responsible Party):
St. Olavs Hospital
  Purpose
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: 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

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

  • change in heart rate variability [ Time Frame: baseline and 52 weeks ]
  • school attendance change [ Time Frame: baseline and 52 weeks ]
  • general health change [ Time Frame: baseline and 52 weeks ]
    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

  Eligibility

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
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
  Contacts and Locations
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


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

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01806246     History of Changes
Other Study ID Numbers: 2012/2159
First Submitted: March 1, 2013
First Posted: March 7, 2013
Last Update Posted: October 23, 2015
Last Verified: October 2015

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

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