Back to resultsA Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome
Primary Purpose
Chronic Fatigue Syndrome
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
integrative rehabilitation program
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring rehabilitation, adolescent, heart rate variability biofeedback, psychoeducation
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
Sites / Locations
- Dept Child and Adolescent Psychiatry, St Olavs Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
integrative rehabilitation program
Arm Description
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.
Outcomes
Primary Outcome Measures
fatigue change
assessed by Fatigue Severity Scale
quality of life change
assessed by Inventory of Life Quality for Children and Adolescents
Secondary Outcome Measures
mood change
assessed by Mood and Feelings Questionnaire
change in heart rate variability
school attendance change
general health change
General Health Questionnaire (GHQ-12)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01806246
Brief Title
A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome
Official Title
An Integrative Approach Based Psychoeducation, Heart Rate Variability Coherence Biofeedback and Elements of, Pacing Cognitive Behavior Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome
Keywords
rehabilitation, adolescent, heart rate variability biofeedback, psychoeducation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
integrative rehabilitation program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
integrative rehabilitation program
Primary Outcome Measure Information:
Title
fatigue change
Description
assessed by Fatigue Severity Scale
Time Frame
baseline and 52 weeks
Title
quality of life change
Description
assessed by Inventory of Life Quality for Children and Adolescents
Time Frame
baseline and 52 weeks
Secondary Outcome Measure Information:
Title
mood change
Description
assessed by Mood and Feelings Questionnaire
Time Frame
baseline and 52 weeks
Title
change in heart rate variability
Time Frame
baseline and 52 weeks
Title
school attendance change
Time Frame
baseline and 52 weeks
Title
general health change
Description
General Health Questionnaire (GHQ-12)
Time Frame
baseline and 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Jozefiak, md phd
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Dept Child and Adolescent Psychiatry, St Olavs Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome
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