Contact information
Type
Scientific
Primary contact
Dr H. Vissers
ORCID ID
Contact details
University Medical Center St Radboud
Expert Center Chronic Fatigue
4628
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)24 3610046
H.Vissers@nkcv.umcn.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR618; 2005/227
Study information
Scientific title
Acronym
Study hypothesis
It is hypothesised that long term disabled persons who participate in the MDR program will return to work and have less mental and/or physical limitations to prevent the pre-disability income. Furthermore, an explorative study into the process variables that are predictive of a successful treatment will be conducted.
Ethics approval
Received from local medical ethics committee
Study design
Randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic Fatigue Syndrome (CFS)
Intervention
Patients in the intervention group will receive a highly individualised treatment by experts on different fields of expertise (i.e. medical, psychological, physical, legal). A major part of this treatment is based on the principles of cognitive behavioral therapy. The MDR program usually last between 12-18 months, depending on the nature of difficulties.
The patients in the control group will receive care as usual.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Off-claim and number of hours in a paid job.
Secondary outcome measures
1. Fatigue severity
2. Functional impairment
3. Physical limitations
4. Psychological well-being
5. Pain
Overall trial start date
01/04/2006
Overall trial end date
01/04/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Extreme fatigue
2. Considerable impairment in daily functioning
3. Disease (objective finding) - illness (subjective complaints) discrepancy present
4. Not older than 45 years
5. Receiving disability benefits for a period longer than 3 years
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
130
Participant exclusion criteria
1. A disease present that can explain the fatigue
2. A history of psychosis or schizophrenia
3. Primary drugs or alcohol abuse
Recruitment start date
01/04/2006
Recruitment end date
01/04/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center St Radboud
Nijmegen
6500 HB
Netherlands
Funders
Funder type
Research organisation
Funder name
Workers Insurance Authority (Uitvoeringsinstituut Werknemers Verzekeringen [UWV]) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Embas Foundation (Stichting Embas) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list