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 |
| Secondary identifying numbers | N/A |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Trudie Chalder
Scientific
Scientific
Department of Psychological Medicine
King's College London
Weston Education Centre
Cutcombe Road
London
SE5 9RJ
United Kingdom
Study information
| 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. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | School attendance expressed as a percentage of what was expected. |
| Secondary outcome measures | 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: 1. Fatigue: Chalder Fatigue Scale - internal consistency in this sample was excellent with a Chronbachs alpha of 0.89 2. Functional impairment: physical functioning subscale of the 36-item Short Form health survey (SF-36) (range 0 to 100 higher scores denoting better health) - this measure is valid and reliable and has been used in adolescents with CFS 3. Degree to which fatigue interfered with adolescents life: Social Adjustment Scale - Chronbachs alpha was 0.91 4. Emotional and social responses: adolescents and their mothers completed the strengths and difficulties questionnaire - this measure has been shown to be valid and reliable in a number of studies 5. Global improvement and satisfaction: Global Outcome Scales - an assessor, blind to the group in which participants were randomised, carried out a semi-structured interview with the adolescent and rated degree of improvement in fatigue and disability on a nine-point scale from much better to much worse |
| Overall study start date | 01/02/2000 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 58 participants |
| 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
- England
- United Kingdom
Study participating centre
Department of Psychological Medicine
London
SE5 9RJ
United Kingdom
SE5 9RJ
United Kingdom
Sponsor information
South London & Maudsley NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Denmark Hill
London
SE5 8AZ
England
United Kingdom
| Website | http://www.slam.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/015803449 |
Funders
Funder type
Government
NHS Executive London Region Office (UK) (ref: RFG 640)
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 | 01/08/2010 | Yes | No |
