Family focused cognitive behaviour therapy versus behaviourally oriented psycho-education for chronic fatigue syndrome in 11 to 18 year olds: a randomised controlled treatment trial
| ISRCTN | ISRCTN59388875 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59388875 |
| Protocol serial number | N/A |
| Sponsor | South London & Maudsley NHS Trust (UK) |
| Funder | NHS Executive London Region Office (UK) (ref: RFG 640) |
- Submission date
- 08/03/2007
- Registration date
- 22/05/2007
- Last edited
- 03/05/2011
- 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
Department of Psychological Medicine
King's College London
Weston Education Centre
Cutcombe Road
London
SE5 9RJ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A randomised controlled trial in which 13 sessions of family focused CBT was compared to 4 sessions of psycho-education over six months. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Cognitive Behaviour Therapy (CBT) will result in higher levels of school return than psycho-education at six months follow up. |
| Ethics approval(s) | King's College London Hospital (UK) on the 14/09/1999 (ref: 99/247) |
| Health condition(s) or problem(s) studied | Chronic Fatigue Syndrome (CFS) otherwise known as Myalgic Encephalomyelitis (ME) |
| Intervention | 13 sessions of family focused CBT versus four sessions of psycho-education over six months. |
| Intervention type | Other |
| Primary outcome measure(s) |
School attendance expressed as a percentage of what was expected. |
| Key secondary outcome measure(s) |
As a secondary outcome school attendance was dichotomised with a good outcome set at 70% or more, as at this age many healthy adolescents are not attending school or college full time. The following were recorded at six months: |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 58 |
| Key inclusion criteria | 1. Adolescents between 11and 18 2. Fulfill criteria for chronic fatigue syndrome 3. Have been investigated by a Paediatrician 4. If on anti-depressants, then had to be on a stable dose for three months |
| Key exclusion criteria | 1. Major depression 2. Somatisation disorder 3. Conversion disorder 4. History of self harm 5. Identifiable disease |
| Date of first enrolment | 01/02/2000 |
| Date of final enrolment | 30/06/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SE5 9RJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/08/2010 | Yes | No |