Survey and Cognitive Behavior Therapy for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
A RCT Study on the Effect of Short and Long Cognitive Behaviour Therapy (CBT) in CFS/ME Patients
2 other identifiers
interventional
234
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 12, 2009
CompletedFirst Posted
Study publicly available on registry
June 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 9, 2020
June 1, 2020
5.2 years
June 12, 2009
June 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Study Arms (3)
8 weeks CBT
EXPERIMENTALControl group
ACTIVE COMPARATOR16 weeks CBT
EXPERIMENTALInterventions
Individual Cognitive Behavior Therapy during 16 weeks
Waiting 16 weeks and receiving 8 weeks individual CBT after waiting period.
Eligibility Criteria
You may qualify if:
- Patients referred to St.Olav Hospital, Trondheim
- fulfil the FUKUDA criteria for CFS/ME.
You may not qualify if:
- Pregnant patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
St.Olavs Hospital
Trondheim, 7006, Norway
Related Publications (2)
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.
PMID: 31169386RESULTGotaas 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.
PMID: 33912079DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Egil Fors, prof MD
St. Olavs Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2009
First Posted
June 15, 2009
Study Start
May 1, 2009
Primary Completion
July 1, 2014
Study Completion
May 1, 2015
Last Updated
June 9, 2020
Record last verified: 2020-06