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Biopsychological Intervention in Chronic Fatigue Syndrome - a Pilot Study

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ClinicalTrials.gov Identifier: NCT02336126
Recruitment Status : Completed
First Posted : January 12, 2015
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital

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.


Condition or disease Intervention/treatment Phase
Adolescent Chronic Fatigue Syndrome Behavioral: Biopsychological intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biopsychological intervention Behavioral: Biopsychological intervention



Primary Outcome Measures :
  1. Chalder fatigue score [ Time Frame: Up to 3 months after inclusion ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02336126


Locations
Norway
Akershus university hospital
Lørenskog, Akershus, Norway, N-1478
Sponsors and Collaborators
Oslo University Hospital

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02336126     History of Changes
Other Study ID Numbers: BIOPSYCH
First Posted: January 12, 2015    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: January 2015

Additional relevant MeSH terms:
Syndrome
Fatigue
Fatigue Syndrome, Chronic
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases