Text Size

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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00920777
First received: June 12, 2009
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Mental and physical function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Mental and physical function, measured by "SF 36". Success criteria are measured by >10 point improvement of mental and/ or physical function.


Estimated Enrollment: 180
Study Start Date: May 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 62 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00920777     History of Changes
Other Study ID Numbers: 21592, 21592, 4.2008.2586
Study First Received: June 12, 2009
Last Updated: March 29, 2012
Health Authority: Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

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

Additional relevant MeSH terms:
Encephalomyelitis
Fatigue
Fatigue Syndrome, Chronic
Encephalitis
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Central Nervous System Infections
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on May 22, 2013