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OpenTrials
Completed

NCT Number: NCT02336126

Biopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akershus university hospital

Lørenskog, Akershus, N-1478, Norway

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Biopsychological intervention

Behavioral

Primary outcomes

  1. Chalder fatigue score

    Time frame: Up to 3 months after inclusion

Secondary outcomes

  1. Patients' experiences (semistructured interview)

    Time frame: Up to 3 months after inclusion

    Qualitative data, further analysed by thematic structural analysis

  2. Quality of Life (PedsQL)

    Time frame: Up to 3 months after inclusion

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 12, 2015
Registry last updated
Apr 18, 2016

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.