Clinical trial NCT00871143: Cognitive Behaviour Therapy (CBT) for Body Dysmorphic Disorder (BDD)
Official title: Efficacy of Cognitive Behaviour Therapy -v- Anxiety Management for Body Dysmorphic Disorder: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Dysmorphic Disorder
Keywords: CBT
BDD
Lead sponsor: Institute of Psychiatry, London
Sponsor class: OTHER
First posted: 2009-03-30
Enrollment: 46
Sex: ALL
Minimum age (years): 17
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the research is to determine if Cognitive Behaviour Therapy (CBT) specific for BDD is more effective than a credible non-specific form of CBT for treating BDD and its delusional variant in adults aged 17 or over. This will be done in a single centre randomised controlled trial that compares specific CBT for BDD versus non-specific CBT over 12 weeks. The hypotheses to be tested are that: (1) specific CBT for BDD will be more effective than non-specific CBT at 12 weeks (2) Treatment effects from Specific CBT will be maintained at 1 month follow up. The main study end-point is at 12 weeks and the secondary end-point is at 1 month follow up. A secondary aim is to explore whether delusionality (insight) as measured by the Brown Assessment of Beliefs and co-morbid depressed mood predicts response to treatment.


Eligibility criteria: Inclusion Criteria:

* BDD is the main psychological problem. We will use DSMIV criteria as BDD does not exist as a separate diagnosis in ICD10. They may have an additional diagnosis of Delusional Disorder when it refers to beliefs about being ugly or defective.
* They must have a total of 24 or more on the twelve-item YBOCS modified for BDD (Phillips et al., 1997).
* They may be of either gender but must be 17 years or above.
* They are willing to travel to the treatment centre for weekly sessions.
* They are wiling to complete regular questionnaires and be audiotaped for supervision and for listening to enhance their learning.
* They may be taking psychotropic medication so long as it is stabilised and there are no plans to increase the dose.

Exclusion Criteria:

* They have a current or past diagnosis of schizophrenia, bipolar affective disorder.
* They have current suicidal intent or severe self-neglect that requires hospitalisation.
* They have a current alcohol or substance dependence or anorexia nervosa or borderline personality disorder that requires treatment in its own right.
* They are currently receiving any other form of psychotherapy,
* They have received CBT for BDD in the past 6 months, which is judged as competently delivered and did not respond.
* They cannot speak sufficient English for CBT. (Assistance will be provided for those who speak English but are unable to read questionnaires).

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)
timeFrame: 12 weeks, 1 month post treatment
Secondary outcomes:
measure: Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)
timeFrame: 12 weeks, 1 month post treatment
measure: Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).
timeFrame: 12 weeks, 1 month post treatment
measure: Appearance Anxiety Inventory (AAI)
timeFrame: 12 weeks, 1 month post treatment
measure: Patient Health Questionnaire (PHQ)-9
timeFrame: 12 weeks, 1 month post treatment
measure: Generalised Anxiety Disorder (GAD)-7
timeFrame: 12 weeks,1 month post treatment
measure: Body Image Quality of Life Inventory (BIQLI)
timeFrame: 12 weeks, 1 month post treatment
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: South London and Maudsley NHS Trust
Study officials:
References:
citation: Veale D, Anson M, Miles S, Pieta M, Costa A, Ellison N. Efficacy of cognitive behaviour therapy versus anxiety management for body dysmorphic disorder: a randomised controlled trial. Psychother Psychosom. 2014;83(6):341-53. doi: 10.1159/000360740. Epub 2014 Oct 16.