Trial record 15 of 30 for:    Open Studies | "Fatigue Syndrome, Chronic"

A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St. Olavs Hospital
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01806246
First received: March 1, 2013
Last updated: April 16, 2014
Last verified: April 2014
  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: 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)


Estimated Enrollment: 15
Study Start Date: February 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806246

Contacts
Contact: Ketil Jakobsen, md ketil.jakobsen@stolav.no

Locations
Norway
Dept Child and Adolescent Psychiatry, St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Ketil Jakobsen, md       ketil.jakobsen@stolav.no   
Sponsors and Collaborators
St. Olavs Hospital
Investigators
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: April 16, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on October 21, 2014