Survey and Cognitive Behavior Therapy for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
Primary Purpose
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Fatigue
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
CBT
CBT
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Fatigue Syndrome focused on measuring CBT, Fukuda criteria, Mental functioning, Physical functioning
Eligibility Criteria
Inclusion Criteria:
- Patients referred to St.Olav Hospital, Trondheim
- fulfil the FUKUDA criteria for CFS/ME.
Exclusion Criteria:
- Pregnant patients
Sites / Locations
- St.Olavs Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
8 weeks CBT
Control group
16 weeks CBT
Arm Description
Outcomes
Primary Outcome Measures
Mental and physical function
Mental and physical function, measured by "SF 36". Success criteria are measured by >10 point improvement of mental and/ or physical function.
Secondary Outcome Measures
Full Information
NCT ID
NCT00920777
First Posted
June 12, 2009
Last Updated
June 6, 2020
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00920777
Brief Title
Survey and Cognitive Behavior Therapy for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
Official Title
A RCT Study on the Effect of Short and Long Cognitive Behaviour Therapy (CBT) in CFS/ME Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Fatigue, Pain
Keywords
CBT, Fukuda criteria, Mental functioning, Physical functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
234 (Actual)
8. Arms, Groups, and Interventions
Arm Title
8 weeks CBT
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Arm Title
16 weeks CBT
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
CBT
Other Intervention Name(s)
Grades excercise therapy
Intervention Description
Individual Cognitive Behavior Therapy during 16 weeks
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
Individual Cognitive Behavior Therapy during 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Control group
Intervention Description
Waiting 16 weeks and receiving 8 weeks individual CBT after waiting period.
Primary Outcome Measure Information:
Title
Mental and physical function
Description
Mental and physical function, measured by "SF 36". Success criteria are measured by >10 point improvement of mental and/ or physical function.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
62 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients referred to St.Olav Hospital, Trondheim
fulfil the FUKUDA criteria for CFS/ME.
Exclusion Criteria:
Pregnant patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Egil Fors, prof MD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St.Olavs Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
31169386
Citation
Rasouli O, Gotaas ME, Stensdotter AK, Skovlund E, Landro NI, Dastol P, Fors EA. Neuropsychological dysfunction in chronic fatigue syndrome and the relation between objective and subjective findings. Neuropsychology. 2019 Jul;33(5):658-669. doi: 10.1037/neu0000550. Epub 2019 Jun 6.
Results Reference
result
PubMed Identifier
33912079
Citation
Gotaas ME, Stiles TC, Bjorngaard JH, Borchgrevink PC, Fors EA. Cognitive Behavioral Therapy Improves Physical Function and Fatigue in Mild and Moderate Chronic Fatigue Syndrome: A Consecutive Randomized Controlled Trial of Standard and Short Interventions. Front Psychiatry. 2021 Apr 12;12:580924. doi: 10.3389/fpsyt.2021.580924. eCollection 2021. Erratum In: Front Psychiatry. 2023 Mar 13;13:1122220.
Results Reference
derived
Learn more about this trial
Survey and Cognitive Behavior Therapy for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
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