Evaluation of telephone-administered cognitive-behaviour therapy (CBT) for young people with obsessive-compulsive disorder (OCD)
| ISRCTN | ISRCTN27070832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27070832 |
| Secondary identifying numbers | PB-PG-0107-12333 |
- Submission date
- 14/08/2008
- Registration date
- 18/09/2008
- Last edited
- 22/10/2015
- 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 of protocol
Not provided at time of registration
Contact information
Dr Cynthia Turner
Scientific
Scientific
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 |
Study information
| Study design | Randomised single-centre single-blind non-inferiority controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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) |
| Study objectives | 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(s) | The Joint South London and Maudsley and the Institute of Psychiatry NHS Research Ethics Committee, 25/03/2008, ref: 08/H0807/12 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2008 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 30/09/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Maudsley Hospital
London
SE5 8AZ
United Kingdom
SE5 8AZ
United Kingdom
Sponsor information
Institute of Psychiatry, Kings College London (UK)
University/education
University/education
c/o Dr Gill Dale
Department of Research and Development
De Crespigny Park
London
SE5 8AF
England
United Kingdom
| Website | http://www.iop.kcl.ac.uk |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK), Research for Patient Benefit (RfPB) Programme (ref: PB-PG-0107-12333)
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 | 01/12/2014 | Yes | No |
