Biopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study

April 15, 2016 updated by: Oslo University Hospital

This is a pilot study of a biopsychological intervention program for adolescent chronic fatigue syndrome. The program is related to cognitive behavioral therapy, which has been proven beneficial in this disorders, but includes other mental techniques, such as emotional control and metacognitive elaboration.

The aim of this pilot study is to explore a) patients' experiences and b) possible positive effects on symptoms. We hypothesise that the intervention will be regarded feasible by the patients, and that fatigue score will improve during the intervention period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Lørenskog, Akershus, Norway, N-1478
        • Akershus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of chronic fatigue syndrome
  • Significant school absenteeism
  • Above 12 years of age and below 18 years of age

Exclusion Criteria:

  • Other diseases or life events that might explain chronic fatigue
  • Bed-ridden

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biopsychological intervention
Behavioral: Biopsychological intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Chalder fatigue score
Time Frame: Up to 3 months after inclusion
Up to 3 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' experiences (semistructured interview)
Time Frame: Up to 3 months after inclusion
Qualitative data, further analysed by thematic structural analysis
Up to 3 months after inclusion
Quality of Life (PedsQL)
Time Frame: Up to 3 months after inclusion
Up to 3 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

August 22, 2014

First Submitted That Met QC Criteria

January 7, 2015

First Posted (Estimate)

January 12, 2015

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOPSYCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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