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Completed

NCT Number: NCT01806246

A Rehabilitation Program for Adolescents With Chronic Fatigue Syndrome

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.

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Key information

Conditions

Chronic Fatigue Syndrome Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

13 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept Child and Adolescent Psychiatry, St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

integrative rehabilitation program

Behavioral

Primary outcomes

  1. fatigue change

    Time frame: baseline and 52 weeks

    assessed by Fatigue Severity Scale

  2. quality of life change

    Time frame: baseline and 52 weeks

    assessed by Inventory of Life Quality for Children and Adolescents

Secondary outcomes

  1. mood change

    Time frame: baseline and 52 weeks

    assessed by Mood and Feelings Questionnaire

  2. change in heart rate variability

    Time frame: baseline and 52 weeks

  3. school attendance change

    Time frame: baseline and 52 weeks

  4. general health change

    Time frame: baseline and 52 weeks

    General Health Questionnaire (GHQ-12)

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 7, 2013
Registry last updated
Oct 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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