ClinicalTrials.gg
CompletedNCT00920777Updated Jun 9, 2020

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

An interventional study of CBT and CBT in Chronic Fatigue Syndrome, Myalgic Encephalomyelitis and Fatigue, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years to 62 Years. Per ClinicalTrials.gov, last updated 2020-06-09.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Treatment

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Phase
Not applicable
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
18 Years to 62 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 25 studies in Fatigue Syndrome, Chronic with a site in Norway — 2 open to participants now, 2 under way, none of them phase 3. Fatigue Syndrome, Chronic · Norway.

Enrollment
Largest of 20
234 · median 45
Started
2009
with 1 other
No phase
11 of 25
1 open now
Registered
3rd of 25
by date
Lead sponsor
5 of 25
Norwegian University of Science and Technology

Among the 25 studies in Fatigue Syndrome, Chronic with a site in Norway, this one has the largest enrollment of the 20 interventional ones that give a count, is one of 2 that started in 2009, is one of 11 with no phase, and was the 3rd registered.

Fatigue Syndrome, Chronic

264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.

Browse Fatigue Syndrome, Chronic studies →

Open to participants now

2 of the 25 studies in Fatigue Syndrome, Chronic with a site in Norway are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Norway have not opened yet or have stopped. Only those recruiting at a site in Norway →

Who these studies take

Of the 44 Fatigue Syndrome, Chronic studies recruiting now, 18 (41%) set no upper age limit and 20 (45%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.

This study: 18 Years to 62 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Chronic Fatigue Syndrome
  • Myalgic Encephalomyelitis
  • Fatigue
  • Pain

Keywords

  • CBT
  • Fukuda criteria
  • Mental functioning
  • Physical functioning
04

Who can participate

Ages eligible
18 Years to 62 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnant patients
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
234 participants (actual)

Study arms

  • Experimental
    8 weeks CBT

    Behavioral: CBT

  • Active comparator
    Control group

    Behavioral: Control group

  • Experimental
    16 weeks CBT

    Behavioral: CBT

Interventions

  • BehavioralCBT

    Individual Cognitive Behavior Therapy during 16 weeks

    Also known as: Grades excercise therapy

  • BehavioralCBT

    Individual Cognitive Behavior Therapy during 8 weeks

  • BehavioralControl group

    Waiting 16 weeks and receiving 8 weeks individual CBT after waiting period.

06

What researchers measure

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.

    Time frame: 1 year

07

Study locations

1 site
  • St.Olavs Hospital
    Trondheim, 7006, Norway
08

References and documents

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 31169386 ↗
  • 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. doi: 10.3389/fpsyt.2022.1122220. PubMed 33912079 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2009, a primary completion of Jul 2014 and a completion of May 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2009
First posted
Jun 15, 2009
Start
May 2009
Primary completionActual
Jul 2014
CompletionActual
May 2015
Last update
Jun 9, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00920777
Collaborators
St. Olavs Hospital
Responsible party
Sponsor
First posted
Jun 15, 2009
Start date
May 2009
Primary completion
Jul 2014
Completion
May 2015
Last update
Jun 9, 2020

Study contacts

Egil Fors, prof MD
principal investigator · St. Olavs Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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