The efficacy and predicting variables of a multidisciplinary disability resolution (MDR) program for Chronic Fatigue Syndrome (CFS) patients receiving long term disability benefits from income protection insurers

ISRCTN ISRCTN31632033
DOI https://doi.org/10.1186/ISRCTN31632033
Secondary identifying numbers NTR618; 2005/227
Submission date
04/04/2006
Registration date
04/04/2006
Last edited
01/09/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr H. Vissers
Scientific

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

Study information

Study designRandomised open label active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesIt 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(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedChronic Fatigue Syndrome (CFS)
InterventionPatients 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 typeOther
Primary outcome measureOff-claim and number of hours in a paid job.
Secondary outcome measures1. Fatigue severity
2. Functional impairment
3. Physical limitations
4. Psychological well-being
5. Pain
Overall study start date01/04/2006
Completion date01/04/2010

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants130
Key inclusion criteria1. 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
Key exclusion criteria1. A disease present that can explain the fatigue
2. A history of psychosis or schizophrenia
3. Primary drugs or alcohol abuse
Date of first enrolment01/04/2006
Date of final enrolment01/04/2010

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center St Radboud
Nijmegen
6500 HB
Netherlands

Sponsor information

University Medical Centre St Radboud, Expert Centre Chronic Fatigue (Netherlands)
Hospital/treatment centre

P.O. Box 9101
Nijmegen
6500 HB
Netherlands

ROR logo https://ror.org/05wg1m734

Funders

Funder type

Research organisation

Workers Insurance Authority (Uitvoeringsinstituut Werknemers Verzekeringen [UWV]) (Netherlands)

No information available

Embas Foundation (Stichting Embas) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan
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