The effectiveness of self-instructions in the treatment of patients with chronic fatigue syndrome (CFS): a randomised controlled study
| ISRCTN | ISRCTN27293439 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27293439 |
| Secondary identifying numbers | CMO 2005/233; NTR570 |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 27/03/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof G. Bleijenberg
Scientific
Scientific
University Medical Centre St. Radboud
Expert Centre Chronic Fatigue
P.O. Box 9011
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 3610030 |
|---|---|
| g.bleijenberg@nkcv.umcn.nl |
Study information
| Study design | Randomised single-blind controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | There are two research questions: 1. Do self-instructions lead to a significant decrease of fatigue and functional impairments of CFS patients compared to a waiting list condition? 2. For which patients are self-instructions a suitable treatment method? |
| Ethics approval(s) | Received from local medical ethics committees |
| Health condition(s) or problem(s) studied | Chronic fatigue syndrome (CFS) |
| Intervention | After a baseline assessment patients are randomly assigned to one of two conditions. In the self-instruction condition patients receive a self-instruction book and email a therapist once every two weeks about their improvements. In the waiting list condition patients receive no treatment after the baseline assessment. After a period of 6 to 12 months patients get a second assessment. Both patients in the self-instruction and in the waiting list condition are then offered (regular) individual cognitive behavioural therapy (CBT) for CFS. As there is a waiting period of 6-12 months for individual CBT because of lack of treatment capacity participation in the self-instruction study will not lead to a longer waiting period for treatment as usual. |
| Intervention type | Other |
| Primary outcome measure | 1. Fatigue (measured with the CIS-Fatigue severity) 2. Disabilities (measured with the SIP total score and SF-36 subscale 'physical functioning') 3. The CIS-f, SIP and SF-36 are used in two assessments, a baseline and a post-treatment (or post waiting list) assessment 4. Determine the effect of the treatment - the difference in CIS-f, SIP and SF-36 scores between baseline and post-treatment for the treatment condition is compared with the difference scores of the waiting list condition |
| Secondary outcome measures | Psychological distress measured with the SCL-90 (symptom checklist 90) |
| Overall study start date | 01/02/2006 |
| Completion date | 01/09/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 196 |
| Key inclusion criteria | 1. Greater than 18 years old 2. Being able to speak and read Dutch 3. Meeting the 1994 research criteria for CFS as formulated by the US Center for Disease Control 4. Severely fatigued (having a CIS-fatigue severity score of greater than or equal to 35) 5. Severely disabled (weighted total score on the Sickness Impact Profile of greater than or equal to 700) 6. Being motivated for treatment of CFS 7. Given written informed consent for participation in the study |
| Key exclusion criteria | 1. Patient does not meet the herefore mentioned inclusion criteria 2. Patient is currently engaged in a legal procedure concerning disability-related financial benefits |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre St. Radboud
Nijmegen
6500 HB
Netherlands
6500 HB
Netherlands
Sponsor information
University Medical Centre St. Radboud (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 9101
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 3611111 |
|---|---|
| info@ozi.umcn.nl | |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Hospital/treatment centre
University Medical Centre St. Radboud (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2008 | Yes | No | |
| Results article | results | 01/09/2013 | Yes | No |
