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ISRCTN
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ISRCTN54248464
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of cognitive behavioural treatment of obsessional compulsive disorder in children and adolescents.
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Scientific title
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Acronym
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N/A
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Serial number at source
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SPGS 808
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Obsessive compulsive disorder (OCD)
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/1999
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Anticipated end date
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30/03/2002
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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21 (added 08/01/10, see publication)
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Interventions
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1. Cognitive behavioural treatment
2. Waitlist control
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Primary outcome measure(s)
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The clinical status of the children and adolescents will be the main focus of the trial. The following tools will be used:
1. KIDDIE-SADS or equivalent semi-structured interview used to assess Mental state of the children
2. YBOCS (child version) used to measure obsessional compulsive symptoms by interview
3. Obsessive compulsive Inventory (OCI) - self-report measure of OCD
4. Responsibility Interpretation Questionnaire (RIQ) - self-report to measure cognitions specific to the treatment methods
5. Children's Depression Inventory (CDI)
6. Multidimensional Anxiety Scale for children (MASC) - self report
7. National Institute of Mental Health (NIMH) global obsessive compulsive scale
Following the example of most other studies in this field the YBOCS total score is considered to be the main focus of analysis.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive South East (UK)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19921305
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Contact name
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Dr
Tim
Williams
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Address
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3 Craven Road
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City/town
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Reading
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Zip/Postcode
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RG1 5LF
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Country
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United Kingdom
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Tel
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+44 (0)118 9315800
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Fax
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+44 (0)118 9750297
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Email
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sxswiams@reading.ac.uk
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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08/01/2010
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Date ISRCTN assigned
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23/01/2004
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