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

June 6, 2020 updated by: Norwegian University of Science and Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7006
        • St.Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 62 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control group
Behavioral: Control group
Waiting 16 weeks and receiving 8 weeks individual CBT after waiting period.
EXPERIMENTAL: 8 weeks CBT
Behavioral: CBT
Individual Cognitive Behavior Therapy during 16 weeks
Other Names:
  • Grades excercise therapy
Behavioral: CBT
Individual Cognitive Behavior Therapy during 8 weeks
EXPERIMENTAL: 16 weeks CBT
Behavioral: CBT
Individual Cognitive Behavior Therapy during 16 weeks
Other Names:
  • Grades excercise therapy
Behavioral: CBT
Individual Cognitive Behavior Therapy during 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Principal Investigator: Egil Fors, prof MD, St. Olavs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

July 1, 2014

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

June 12, 2009

First Submitted That Met QC Criteria

June 12, 2009

First Posted (ESTIMATE)

June 15, 2009

Study Record Updates

Last Update Posted (ACTUAL)

June 9, 2020

Last Update Submitted That Met QC Criteria

June 6, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21592 (NSD)
  • 4.2008.2586 (OTHER: REK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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