Back to resultsBiopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study
Primary Purpose
Adolescent Chronic Fatigue Syndrome
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Biopsychological intervention
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Chronic Fatigue Syndrome
Eligibility Criteria
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
Sites / Locations
- Akershus university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biopsychological intervention
Arm Description
Outcomes
Primary Outcome Measures
Chalder fatigue score
Secondary Outcome Measures
Patients' experiences (semistructured interview)
Qualitative data, further analysed by thematic structural analysis
Quality of Life (PedsQL)
Full Information
NCT ID
NCT02336126
First Posted
August 22, 2014
Last Updated
April 15, 2016
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02336126
Brief Title
Biopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oslo University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Chronic Fatigue Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biopsychological intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Biopsychological intervention
Primary Outcome Measure Information:
Title
Chalder fatigue score
Time Frame
Up to 3 months after inclusion
Secondary Outcome Measure Information:
Title
Patients' experiences (semistructured interview)
Description
Qualitative data, further analysed by thematic structural analysis
Time Frame
Up to 3 months after inclusion
Title
Quality of Life (PedsQL)
Time Frame
Up to 3 months after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Akershus university hospital
City
Lørenskog
State/Province
Akershus
ZIP/Postal Code
N-1478
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
Biopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study
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