Condition category
Nervous System Diseases
Date applied
04/04/2006
Date assigned
04/04/2006
Last edited
01/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

University Medical Centre St Radboud, Expert Centre Chronic Fatigue (Netherlands)

Sponsor details

P.O. Box 9101
Nijmegen
6500 HB
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes