Contact information
Type
Scientific
Primary contact
Dr Cynthia Turner
ORCID ID
Contact details
Obsessive-Compulsive and Related Disorders Clinic
Michael Rutter Centre for Children and Young People
Maudsley Hospital
De Crespigny Park
London
SE5 8AZ
United Kingdom
-
cynthia.turner@slam.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PB-PG-0107-12333
Study information
Scientific title
An evaluation of the clinical effectiveness, cost-effectiveness and acceptability of a telephone-administered cognitive-behaviour therapy (CBT) programme for children and young people with obsessive-compulsive disorder (OCD)
Acronym
Study hypothesis
1. The clinical outcome of cognitive-behaviour therapy (CBT) delivered by telephone will be equivalent to CBT treatment delivered face-to-face in the treatment of childhood OCD
2. Telephone CBT for young people will be a cost-effective means of service delivery
3. Young people and their families will find this treatment acceptable and convenient
Ethics approval
The Joint South London and Maudsley and the Institute of Psychiatry NHS Research Ethics Committee, 25/03/2008, ref: 08/H0807/12
Study design
Randomised single-centre single-blind non-inferiority controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obsessive-compulsive disorder (OCD)
Intervention
Participants will be randomly allocated to receive either face-to-face CBT or telephone-administered CBT. All participants will receive up to 14 sessions of CBT within 17 weeks (each CBT session lasts approximately 55 minutes).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The following will be measured at assessment, baseline, post-treatment, 3-month, 6-month and 12-month follow-up:
1. A diagnosis of OCD, as measured by the Anxiety Disorders Interview Schedule for DSM-IV Parent/Child Versions (ADIS-IV-C/P)
2. The severity of OCD symptoms, as measured by the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Secondary outcome measures
The following will be measured at assessment, baseline, post-treatment, 3-month, 6-month and 12-month follow-up:
1. Children's Obsessive-Compulsive Inventory (ChOCI C/P)
2. Strengths and Difficulties Questionnaire (SDQ)
3. Beck Depression Inventory for Youth (BDI-Y)
4. Depression, Anxiety and Stress Scales (DASS)
5. Family Accommodation Scale (FAS)
6. Children's Global Assessment Scale (CGAS)
7. Child and Adolescent Service Use Schedule (CA-SUS)
8. EuroQol-5D (EQ-5D)
Overall trial start date
01/09/2008
Overall trial end date
30/09/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Both males and females, age 11 to 18 years
2. Primary Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of OCD
3. Stable medication for 12 weeks (if relevant)
4. Access to a telephone
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Current diagnosis of psychosis, current alcohol or substance abuse/dependence
2. English too poor to engage in treatment without an interpreter being required
3. Severe disabling neurological disorder
4. A diagnosed global learning disability or pervasive developmental delay
5. Characteristics interfering with completion of treatment e.g. life-threatening or unstable medical illness
Recruitment start date
01/09/2008
Recruitment end date
30/09/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Maudsley Hospital
London
SE5 8AZ
United Kingdom
Sponsor information
Organisation
Institute of Psychiatry, Kings College London (UK)
Sponsor details
c/o Dr Gill Dale
Department of Research and Development
De Crespigny Park
London
SE5 8AF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK), Research for Patient Benefit (RfPB) Programme (ref: PB-PG-0107-12333)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25457928