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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02336126
Other study ID # BIOPSYCH
Secondary ID
Status Completed
Phase N/A
First received August 22, 2014
Last updated April 15, 2016
Start date October 2014
Est. completion date January 2015

Study information

Verified date January 2015
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway: 'Regional committees for medical and health research ethics'
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 18 Years
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Biopsychological intervention


Locations

Country Name City State
Norway Akershus university hospital Lørenskog Akershus

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Chalder fatigue score Up to 3 months after inclusion No
Secondary Patients' experiences (semistructured interview) Qualitative data, further analysed by thematic structural analysis Up to 3 months after inclusion Yes
Secondary Quality of Life (PedsQL) Up to 3 months after inclusion No