Cognitive-behaviour therapy for adolescents with body dysmorphic disorder
| ISRCTN | ISRCTN67699666 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67699666 |
| Protocol serial number | 11503 |
| Sponsor | King's College London (UK) |
| Funder | NIHR Research for Patient Benefit Programme (UK) ref: PB-PG-0110-21231 |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A pilot randomized controlled trial of cognitive-behaviour therapy for children and adolescents with body dysmorphic disorder |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
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. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 31/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key 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 |
| Key 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. |
| Date of first enrolment | 15/02/2012 |
| Date of final enrolment | 31/12/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Michael Rutter Centre for Children
London
SE5 8AZ
United Kingdom
SE5 8AZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
