A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome

• Sponsor: St. Olavs Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01806246
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arm: 1
• Duration (Months): 30.9
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Fatigue Syndrome	Behavioral: integrative rehabilitation program	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: N/A
• 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
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. fatigue change [baseline and 52 weeks]

   assessed by Fatigue Severity Scale

2. quality of life change [baseline and 52 weeks]

   assessed by Inventory of Life Quality for Children and Adolescents

Secondary Outcome Measures

1. mood change [baseline and 52 weeks]

   assessed by Mood and Feelings Questionnaire

2. change in heart rate variability [baseline and 52 weeks]

3. school attendance change [baseline and 52 weeks]

4. general health change [baseline and 52 weeks]

   General Health Questionnaire (GHQ-12)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Olavs Hospital
• ClinicalTrials.gov Identifier: NCT01806246
• Other Study ID Numbers: 2012/2159
• First Posted: Mar 7, 2013
• Last Update Posted: Oct 23, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by St. Olavs Hospital: rehabilitation; adolescent; heart rate variability biofeedback; psychoeducation
• Additional relevant MeSH terms: Fatigue Syndrome, Chronic; Syndrome; Fatigue

Study Results

No Results Posted as of Oct 23, 2015