Condition category
Mental and Behavioural Disorders
Date applied
14/08/2008
Date assigned
18/09/2008
Last edited
22/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.iop.kcl.ac.uk

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

Publication citations

Additional files

Editorial Notes