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

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ClinicalTrials.gov Identifier: NCT00920777
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : June 10, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Chronic Fatigue Syndrome Myalgic Encephalomyelitis Fatigue Pain Behavioral: CBT Behavioral: Control group

Study Design

Study Type : Interventional  (Clinical Trial)
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 2009
Primary Completion Date : July 2014
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Grades excercise therapy


Outcome Measures

Primary Outcome Measures :
  1. Mental and physical function [ Time Frame: 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

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients referred to St.Olav Hospital, Trondheim
  • fulfil the FUKUDA criteria for CFS/ME.

Exclusion Criteria:

  • Pregnant patients
Contacts and Locations

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): NCT00920777


Locations
Norway
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
More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00920777     History of Changes
Other Study ID Numbers: 21592
21592 ( Other Identifier: NSD )
4.2008.2586 ( Other Identifier: REK )
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015

Keywords provided by Norwegian University of Science and Technology:
CBT
Fukuda criteria
Mental functioning
Physical functioning

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