Cognitive-behaviour therapy for adolescents with body dysmorphic disorder
| ISRCTN | ISRCTN67699666 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67699666 |
| Secondary identifying numbers | 11503 |
- Submission date
- 23/08/2012
- Registration date
- 23/08/2012
- Last edited
- 28/10/2015
- 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
Not provided at time of registration
Contact information
Dr Jacinda Cadman
Scientific
Scientific
Michael Rutter Centre for Children
Maudsley Hospital
Denmark Hill
London
SE5 8AZ
United Kingdom
| Jacinda.Cadman@slam.nhs.uk |
Study information
| Study design | Randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 | A pilot randomized controlled trial of cognitive-behaviour therapy for children and adolescents with body dysmorphic disorder |
| Study hypothesis | This is a pilot study to develop a specific CBT protocol for Body Dismorphic Disorder (BDD) in children and adolescents and to test the efficacy of this intervention via a pilot randomised controlled trial (RCT). Existing adult CBT protocol will be modified to suit young people with BDD and their families. The study will randomly allocate 30 young people with BDD to: 1. A BDDspecific CBT protocol involving 14 sessions over 4 months, or 2. A waitist control group comprising a psychoeducation package. All patients will be followed up for 12 months after the end of the treatment. The results and study protocol/materials will be widely disseminated. The results will provide crucial efficacy data which will form the solid basis for future phase III/IV effectiveness trials. |
| Ethics approval(s) | ref: 11/LO/1605 |
| Condition | Personality disorders |
| Intervention | CBT, Cognitive Behaviour therapy (CBT) designed for young people with BDD, and their families. The current trial involves 14 CBT sessions over 4 months and 4 follow up sessions over 12 months. Follow Up Length: 12 months |
| Intervention type | Other |
| Primary outcome measure | 1. The Yale Brown Obsessive Compulsive Scale Modified for BDD Adolescent Version (BDD-YBOCS-A) 2. Admin to all participants at pre, mid, and post-intervention and at 2, 6, and 12 months follow-up. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 15/02/2012 |
| Overall study end date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 30 |
| Participant inclusion criteria | 1. Age 12 to 18 2. DSM-IV diagnosis of BDD (they may have an additional diagnosis of Delusional Disorder when it refers to beliefs about being ugly or defective) 3. Score of 24 or higher on the 12-item BDDY-BOCS, indicating substantial symptom severity 4. Stable psychotropic medication for 12 weeks prior to randomisation (if relevant) 5. No plans to commence or increase the dose of psychotropic medication (if relevant) 6. Willingness to receive psychological treatment 7. Willingness to be randomised to a waitlist/psychoeducation control condition 8. Willingness/ability to travel to the clinic for CBT 9. Male and female participants 10. Aged between 12 - 18 years |
| Participant exclusion criteria | 1. Current or past diagnosis of schizophrenia or bipolar affective disorder, current alcohol or substance dependence, severe disabling neurological disorder, global learning disability, pervasive developmental disorder, or an emerging borderline personality disorder that requires treatment in its own right 2. The patient has suicidal intent that requires hospitalisation 3. English too poor to engage in treatment; characteristics interfering with completion of treatment e.g. selective mutism, lack of motivation, unable to attend clinic. |
| Recruitment start date | 15/02/2012 |
| Recruitment end date | 31/12/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Michael Rutter Centre for Children
London
SE5 8AZ
United Kingdom
SE5 8AZ
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Institute of Psychiatry
Department of Psychology
Henry Wellcome Building
16 De Crespigny Park
London
SE5 8AF
England
United Kingdom
| Website | http://www.kcl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
NIHR Research for Patient Benefit Programme (UK) ref: PB-PG-0110-21231
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 | 01/11/2015 | Yes | No |
