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Survey and Cognitive Behavior Therapy for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

Sponsor
Norwegian University of Science and Technology (Other)
Overall Status
Completed
CT.gov ID
NCT00920777
Collaborator
St. Olavs Hospital (Other)
234
Enrollment
1
Location
3
Arms
72
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to analyze income variables in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, and to analyze the effect of short vs. long Cognitive Behaviour Therapy.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CBT
  • Behavioral: CBT
  • Behavioral: Control group
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
234 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A RCT Study on the Effect of Short and Long Cognitive Behaviour Therapy (CBT) in CFS/ME Patients
Study Start Date :
May 1, 2009
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 8 weeks CBT

Behavioral: CBT
Individual Cognitive Behavior Therapy during 8 weeks
Active Comparator: Control group

Behavioral: Control group
Waiting 16 weeks and receiving 8 weeks individual CBT after waiting period.
Experimental: 16 weeks CBT

Behavioral: CBT
Individual Cognitive Behavior Therapy during 16 weeks
Other Names:
  • Grades excercise therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mental and physical function [1 year]

      Mental and physical function, measured by "SF 36". Success criteria are measured by >10 point improvement of mental and/ or physical function.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 62 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients referred to St.Olav Hospital, Trondheim

    • fulfil the FUKUDA criteria for CFS/ME.

    Exclusion Criteria:
    • Pregnant patients

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St.Olavs Hospital Trondheim Norway 7006

    Sponsors and Collaborators

    • Norwegian University of Science and Technology
    • St. Olavs Hospital

    Investigators

    • Principal Investigator: Egil Fors, prof MD, St. Olavs Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Norwegian University of Science and Technology
    ClinicalTrials.gov Identifier:
    NCT00920777
    Other Study ID Numbers:
    • 21592
    • 21592
    • 4.2008.2586
    First Posted:
    Jun 15, 2009
    Last Update Posted:
    Jun 9, 2020
    Last Verified:
    Jun 1, 2020
    Keywords provided by Norwegian University of Science and Technology
    CBT
    Fukuda criteria
    Mental functioning
    Physical functioning
    Additional relevant MeSH terms:
    Fatigue Syndrome, Chronic
    Encephalomyelitis
    Myalgia
    Syndrome
    Fatigue

    Study Results

    No Results Posted as of Jun 9, 2020