A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome

Chronic Fatigue Syndrome Clinical Trial

Official title:

An Integrative Approach Based Psychoeducation, Heart Rate Variability Coherence Biofeedback and Elements of, Pacing Cognitive Behavior Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806246
• Other study ID #: 2012/2159
• Status: Completed
• Phase: N/A
• First received: March 1, 2013
• Last updated: October 22, 2015
• Start date: February 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic

Intervention

Behavioral:
• integrative rehabilitation program

Locations

Country	Name	City	State
Norway	Dept Child and Adolescent Psychiatry, St Olavs Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fatigue change	assessed by Fatigue Severity Scale	baseline and 52 weeks	No
Primary	quality of life change	assessed by Inventory of Life Quality for Children and Adolescents	baseline and 52 weeks	No
Secondary	mood change	assessed by Mood and Feelings Questionnaire	baseline and 52 weeks	No
Secondary	change in heart rate variability		baseline and 52 weeks	No
Secondary	school attendance change		baseline and 52 weeks	No
Secondary	general health change	General Health Questionnaire (GHQ-12)	baseline and 52 weeks	No