Controlled evaluation of Cognitive Behaviour Therapy (CBT) for Obsessive Compulsive Disorder (OCD) in children and adolescents: comparison of standard, therapist intensive therapy versus brief therapy

ISRCTN	ISRCTN29092580
DOI	https://doi.org/10.1186/ISRCTN29092580
Secondary identifying numbers	MREC 0312045

Submission date: 11/03/2004
Registration date: 11/05/2004
Last edited: 04/07/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Derek Bolton
Scientific

Department of Psychology
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Phone	+44 (0)20 7848 5011
Email	D.Bolton@iop.kcl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study hypothesis	The aims of the study are: 1. To determine the effectiveness of Cognitive Behaviour Therapy (CBT) for children and adolescents with Obsessive Compulsive Disorder (OCD) and the extent to which this can be sustained by a treatment with relatively low intensity of therapist contact 2. To produce a treatment practice manual suitable for dissemination 3. To identify patient characteristics that may be related to differential treatment response 4. To determine whether treatment improves quality of life 5. To investigate service use associated with the two treatments
Ethics approval(s)	No ethics information provided at time of registration.
Condition	Obsessive Compulsive Disorder
Intervention	Participants will be randomly assigned to one of three conditions: 1. Standard CBT: comprising 12 sessions therapist contact and handouts explaining the features of OCD and its treatment. Both this and the brief CBT will be delivered over a three month period. 2. Brief CBT: comprising five sessions therapist contact and use of a detailed multi-section work-book intended to supplement the therapy sessions. 3. Waiting-list/delayed treatment, for three months. At the end of this period if the child still has diagnosable OCD they will be offered treatment in either of the first two conditions on a randomized basis. This group will act as the control group for the study.
Intervention type	Other
Primary outcome measure	Child Yale-Brown Obsessive Compulsive Scale (CY-BOCS) (Scahill et al. 1997).
Secondary outcome measures	1. Anxiety Disorders Interview Schedule for Children and Parents (ADIS-C/P, Silverman & Nelles, 1988) 2. Obsessive Compulsive Inventory (OCI) adapted for use with children (Foa et al. 1997) 3. Responsibility Attitude Scale (Salkovskis et al. 2000) 4. Child OCD Impact Scale (COIS) child and parent version (Piacentini et al. 2001) 5. Manchester Short Assessment of Quality of Life (MANSA) (Priebe et al. 1999)
Overall study start date	01/10/2003
Overall study end date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	10 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	110
Participant inclusion criteria	1. Aged 10 to 18 2. Diagnosis of OCD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) criteria 3. If on medication, on a stable dosage for at least six weeks
Participant exclusion criteria	1. Immediate suicide risk 2. Intelligence Quotient (IQ) less than 70 3. Comorbid diagnosis of autism or marked autistic spectrum features, or psychosis, which commonly raise problems about differential diagnosis 4. Comorbid condition which has greater treatment priority (such as some cases of depression, or school-refusal)
Recruitment start date	01/10/2003
Recruitment end date	31/03/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Psychology

London
SE5 8AF
United Kingdom

Sponsor information

King's College London (UK)
University/education

Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
England
United Kingdom

Email	G.Dale@iop.kcl.ac.uk
"ROR"	https://ror.org/0220mzb33

Funders

Funder type

Charity

The Health Foundation (UK) (reference Number 1206/1782)

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	01/12/2011		Yes	No