The effectiveness of cognitive behavioural therapy in groups for patients with Chronic Fatigue Syndrome (CFS): a randomised controlled study
| ISRCTN | ISRCTN15823716 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15823716 |
| Protocol serial number | CMO 2006/030 |
| Sponsor | University Medical Center St. Radboud (The Netherlands) |
| Funder | University Medical Center St. Radboud (The Netherlands) |
- Submission date
- 12/10/2006
- Registration date
- 12/10/2006
- Last edited
- 12/10/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University Medical Center St. Radboud
Expert Center Chronic Fatigue
P.O. Box 9011
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)24 3610030 |
|---|---|
| g.bleijenberg@nkcv.umcn.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | There are two research questions: 1. Does Cognitive Behavioural Therapy (CBT) in groups lead to a significant decrease of fatigue and functional impairment of Chronic Fatigue Syndrome (CFS) patients compared to a waiting list condition? 2. For which patient is group therapy a suitable treatment method? |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Chronic Fatigue Syndrome (CFS) |
| Intervention | After a basline assessment patients are randomly assigned to one of three conditions. There are two treatment conditions: small group (four patients and one therapist) and large group (eight patients and two therapists). Both group treatments consist of 16 sessions of two hours in a period of about six months. There is a second assessment after the treatment. The third condition is a waiting list condition. After the waiting period of at least six months, patients get a second assessment. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Fatigue severity (measured with the CIS subscale fatigue severity). |
| Key secondary outcome measure(s) |
Psychological distress measured with the Symptom Checklist 90 (SCL 90). |
| Completion date | 01/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 204 |
| Key inclusion criteria | 1. Over 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 Checklist Individual Strength (CIS)-fatigue severity score of more than or equal to 35) 5. Severely disabled (weighted total score on the Sickness Impact Profile of more than or equal to 700) 6. Motivated for treatment of CFS with CBT 7. Having functioned good in groups before (self-report) and willing to follow a group treatment for CFS 8. Given written informed consent for participation in the study |
| Key exclusion criteria | 1. Patient does not meet the previously mentioned inclusion criteria 2. Patient is currently engaged in a legal procedure concerning disability-related financial benefits |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 01/12/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
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 |
