Chronic Fatigue SyndromeNCT00920777
Survey and Cognitive Behavior Therapy for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
A study testing CBT in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Fatigue
- What is being tested?
- CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteNorway
- Study dates
- May 2009to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients referred to St.Olav Hospital, Trondheim
- fulfil the FUKUDA criteria for CFS/ME.
Who cannot join
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A RCT Study on the Effect of Short and Long Cognitive Behaviour Therapy (CBT) in CFS/ME Patients
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.
- Conditions
- Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Fatigue, Pain
- Being tested
- CBT, Control group
- Keywords
- CBT, Fukuda criteria, Mental functioning, Physical functioning
- Medical subject headings
- Fatigue Syndrome, Chronic, Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
Also called Grades excercise therapy
Individual Cognitive Behavior Therapy during 16 weeks
CBTBehavioural
Individual Cognitive Behavior Therapy during 8 weeks
Control groupBehavioural
Waiting 16 weeks and receiving 8 weeks individual CBT after waiting period.
| Study group | Role | What they receive |
|---|---|---|
| 8 weeks CBT | Experimental | Not described Receives: Behavioral: CBT |
| Control group | Active comparator | Not described Receives: Behavioral: Control group |
| 16 weeks CBT | Experimental | Not described Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Egil Fors, prof MD, Principal investigator, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920777
- Sponsor's protocol ID
- 21592
- Other IDs
- 21592, 4.2008.2586
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2009
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31169386Gotaas 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.
PubMed 33912079
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A RCT Study on the Effect of Short and Long Cognitive Behaviour Therapy (CBT) in CFS/ME Patients
- ClinicalTrials.gov ID
- NCT00920777
- Acronym / sponsor ID
- 21592
- Conditions
- Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Fatigue, Pain
- Keywords
- CBT, Fukuda criteria, Mental functioning, Physical functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- May 2009
- Primary completion
- Jul 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 15 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 8 weeks CBT | Experimental | Behavioral: CBT |
| Control group | Active comparator | Behavioral: Control group |
| 16 weeks CBT | Experimental | Behavioral: CBT |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients referred to St.Olav Hospital, Trondheim
- fulfil the FUKUDA criteria for CFS/ME.
Key exclusion criteria (1 listed)
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBTAlso: Grades excercise therapyIndividual Cognitive Behavior Therapy during 16 weeks | Behavioural | 16 weeks CBT |
| CBTIndividual Cognitive Behavior Therapy during 8 weeks | Behavioural | 8 weeks CBT |
| Control groupWaiting 16 weeks and receiving 8 weeks individual CBT after waiting period. | Behavioural | Control group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Results publication: PubMed 31169386Rasouli 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.
- Derived from this study: PubMed 33912079Gotaas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egil Fors, prof MD principal investigator
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT in people with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental and physical function (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00920777, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.