NCT02336126CompletedNot Applicable
Biopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study
Oslo University Hospital2 sites in 1 country8 target enrollmentStarted: October 1, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Chalder fatigue score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Chalder fatigue score
Time Frame: Up to 3 months after inclusion
Secondary Outcomes
- Patients' experiences (semistructured interview)(Up to 3 months after inclusion)
- Quality of Life (PedsQL)(Up to 3 months after inclusion)
Investigators
Study Sites (2)
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