A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome

Not Applicable

Completed

• Conditions: Chronic Fatigue Syndrome
• Interventions: Behavioral: integrative rehabilitation program

• Registration Number: NCT01806246
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-01
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-07
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-22
• Last Update Posted: 2015-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
integrative rehabilitation program	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.

Primary Outcome Measures

Name	Time	Method
fatigue change	baseline and 52 weeks	assessed by Fatigue Severity Scale
quality of life change	baseline and 52 weeks	assessed by Inventory of Life Quality for Children and Adolescents

Secondary Outcome Measures

Name	Time	Method
change in heart rate variability	baseline and 52 weeks
school attendance change	baseline and 52 weeks
mood change	baseline and 52 weeks	assessed by Mood and Feelings Questionnaire
general health change	baseline and 52 weeks	General Health Questionnaire (GHQ-12)

Trial Locations

Locations (1)

Dept Child and Adolescent Psychiatry, St Olavs Hospital; 🇳🇴 Trondheim, Norway