Title: A pilot randomized controlled trial of cognitive-behaviour therapy for children and adolescents with body dysmorphic disorder
Funder: Department of Health (England)

Abstract: Background Body Dysmorphic Disorder (BDD) is a disabling mental disorder, which has an adolescent onset in 70% of cases, and is associated with major functional impairment including social withdrawal, dropping out from school, and strikingly high suicidal rates. Despite having a prevalence of approximately 2% of the population, it remains poorly recognised and undertreated. The NICE guideline on assessment and treatment of BDD recommends that Cognitive Behaviour Therapy (CBT) should be offered as a first-line treatment to all children and adolescents with the diagnosis. However, the evidence base for CBT in paediatric-onset BDD is currently limited to a handful of single case studies. A controlled trial is now needed. Aims Our primary aim is to develop a BDD-specific CBT protocol that is adapted to suit the developmental stage of the young person and involves the family and/or carers when appropriate, and to test the efficacy of this intervention via a pilot randomised controlled trial (RCT). Secondary aims are to establish whether the therapeutic gains are maintained in the long run (12 months), to assess the impact of the treatment on the young person’s quality of life, and on parental stress and family functioning and to evaluate treatment satisfaction and whether the intervention is acceptable to young people and their parents/carers using qualitative methods. This phase II efficacy trial will provide crucial data for designing a more definitive phase III/IV effectiveness/ cost-effectiveness trial. Plan of Investigation Existing adult CBT protocol/treatment manuals will be modified to suit young people with BDD and their families. The trial will be widely advertised across CAMHS services, patient organisations and schools in order to raise awareness and increase referral rates. Thirty patients will be randomised to a) BDD-specific CBT protocol including 14 sessions over 4 months, or b) a waitlist control (care as usual) of equivalent duration. Patients in the waitlist arm will be offered CBT immediately after the waitlist period. All patients will be followed-up for 12 months after the end of treatment. Parental stress, family functioning, satisfaction and acceptability for the patients and their parents/carers will be assessed. The results and study protocol/materials will be widely disseminated. Potential Impact If the intervention is acceptable and efficacious, the results will have direct implications for sufferers nation-wide in the short-medium term. Immediate benefits include the dissemination of the results and treatment protocol/materials among our peers, which hopefully will increase detection of BDD and improve access to evidence-based treatment. Since the evidence base for CBT in paediatric BDD is lacking, the results will provide crucial efficacy data which will form the solid basis for future phase III/IV effectiveness trials that will eventually lead to the intervention being rolled-out across the NHS.


Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH