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Clinical Trials/ISRCTN77567702
ISRCTN77567702
Completed
N/A

Is a multidisciplinary rehabilitation treatment more effective than monodisciplinary cognitive behavioural therapy for patients with chronic fatigue syndrome? A multicentre randomised controlled trial

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)0 sites240 target enrollmentFebruary 27, 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Enrollment
240
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 27, 2009
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Eligibility Criteria

Inclusion Criteria

  • Patients are included if they fulfil the CDC\-94 criteria for CFS and score more or equal to 40 on the Checklist Individual Strength (CIS)\-fatigue questionnaire. CDC\-94 criteria for CFS are as follows:
  • At least 6 months of persistent or recurring fatigue for which no physical explanation has been found and which:
  • 1\. Is of new onset, that is to say it has not been lifelong
  • 2\. Is not the result of ongoing exertion
  • 3\. Is not substantially alleviated by rest
  • 4\. Severely limits functioning
  • In combination with four or more of the following symptoms, persistent or regularly recurring over a period of 6 months and which must not have predated the fatigue:
  • 5\. Self\-reported impairment in memory or concentration
  • 6\. Sore throat
  • 7\. Tender cervical lymph nodes

Exclusion Criteria

  • 1\. Any medical condition that may explain the presence of chronic fatigue
  • 2\. A psychotic, major or bipolar depressive disorder (but not an uncomplicated depression)
  • 3\. Dementia
  • 4\. Anorexia or bulimia nervosa
  • 5\. Alcohol and/or drug abuse
  • 6\. Severe obesity (body mass index \[BMI] greater than or equal to 45\)
  • 7\. Pregnancy
  • 8\. Not able to speak, understand or write the Dutch language
  • 9\. Patients who had cognitive behavioural therapy (CBT) and multidisciplinary rehabilitation therapy (MRT) in the past involving CFS

Outcomes

Primary Outcomes

Not specified

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