Condition category
Mental and Behavioural Disorders
Date applied
23/08/2012
Date assigned
23/08/2012
Last edited
28/10/2015
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 Jacinda Cadman

ORCID ID

Contact details

Michael Rutter Centre for Children
Maudsley Hospital
Denmark Hill
London
SE5 8AZ
United Kingdom
-
Jacinda.Cadman@slam.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11503

Study information

Scientific title

A pilot randomized controlled trial of cognitive-behaviour therapy for children and adolescents with body dysmorphic disorder

Acronym

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

ref: 11/LO/1605

Study design

Randomised interventional trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

15/02/2012

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

UK Sample Size: 30

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

United Kingdom

Trial participating centre

Michael Rutter Centre for Children
London
SE5 8AZ
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Institute of Psychiatry
Department of Psychology
Henry Wellcome Building
16 De Crespigny Park
London
SE5 8AF
United Kingdom

Sponsor type

University/education

Website

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

Funders

Funder type

Government

Funder name

NIHR Research for Patient Benefit Programme (UK) ref: PB-PG-0110-21231

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

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26506580

Publication citations

Additional files

Editorial Notes