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 |
| Protocol serial number | NTR618; 2005/227 |
| Sponsor | University Medical Centre St Radboud, Expert Centre Chronic Fatigue (Netherlands) |
| Funders | Workers Insurance Authority (Uitvoeringsinstituut Werknemers Verzekeringen [UWV]) (Netherlands), Embas Foundation (Stichting Embas) (Netherlands) |
- 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
Scientific
University Medical Center St Radboud
Expert Center Chronic Fatigue, 4628
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 3610046 |
|---|---|
| H.Vissers@nkcv.umcn.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised open label active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Off-claim and number of hours in a paid job. |
| Key secondary outcome measure(s) |
1. Fatigue severity |
| Completion date | 01/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 130 |
| Key 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 |
| Key exclusion criteria | 1. A disease present that can explain the fatigue 2. A history of psychosis or schizophrenia 3. Primary drugs or alcohol abuse |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 01/04/2010 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center St Radboud
Nijmegen
6500 HB
Netherlands
6500 HB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
