Randomised controlled trial of cognitive behavioural treatment of obsessional compulsive disorder in children and adolescents.
| ISRCTN | ISRCTN54248464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54248464 |
| Protocol serial number | SPGS 808 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South East (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 08/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
3 Craven Road
Reading
RG1 5LF
United Kingdom
| Phone | +44 (0)118 9315800 |
|---|---|
| sxswiams@reading.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To evaluate the efficacy of cognitive behavioural treatment for children and adolescents with obsessive compulsive disorder. OCD is a severely handicapping chronic relapsing psychological disorder with affects 0.5% to 2% of the population. 50% of adults with OCD develop the condition in adolescence, and 50% of the children with OCD continue to be disabled by it in adulthood. Although cognitive behavioural treatment (CBT) is the first choice treatment in childhood according to recent consensus guidelines, there has only been one RCT in adolescents and children. That study suffers from difficulties of interpretation and used a less powerful form of CBT than the best currently used with adults. RCTs in adulthood have found that 70& of patients with OCD benefit from CBT, and remain well following the end of treatment. Research Objectives: To carry out a trial of a manulised cognitive behavioural treatment for obsessional compulsive disorder in children and adolescents, in order to ensure that it is effective in reducing the level of symptoms. To investigate the extent of the improvements in functioning resulting from the treatment method and compare them with the effects of time spent waiting for treatment. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Obsessive compulsive disorder (OCD) |
| Intervention | 1. Cognitive behavioural treatment 2. Waitlist control |
| Intervention type | Other |
| Primary outcome measure(s) |
The clinical status of the children and adolescents will be the main focus of the trial. The following tools will be used: |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/03/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 8 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 21 |
| Key inclusion criteria | Children and adolescents aged between 8 years and 18 years of age in full time education with obsessional compulsive disorder defined by research diagnostic criteria and whose medication has remained stable for 12 weeks prior to entry to trial. |
| Key exclusion criteria | Children with severe learning disabilities or severe language difficulties - because the treatment requires the use of verbal reasoning skills at the eight year plus level |
| Date of first enrolment | 01/10/1999 |
| Date of final enrolment | 30/03/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
RG1 5LF
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 | 01/05/2010 | Yes | No |
