Cognitive Behaviour Therapy (CBT) for Body Dysmorphic Disorder (BDD)

Body Dysmorphic Disorder Clinical Trial

Official title:

Efficacy of Cognitive Behaviour Therapy -v- Anxiety Management for Body Dysmorphic Disorder: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871143
• Other study ID #: PAXKAYR
• Secondary ID: 0
• Status: Completed
• Phase: N/A
• First received: March 27, 2009
• Last updated: September 4, 2015
• Start date: April 2009
• Est. completion date: September 2012

Study information

• Verified date: September 2015
• Source: Institute of Psychiatry, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2012
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 65 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Dysmorphic Disorder
• Body Dysmorphic Disorders

Intervention

Behavioral:
• CBT specific for BDD
This consisted of 12 wks of 1 hr sessions (1 per week).The consisted of engagement in a developmental understanding of the problem and setting up an alternative view of the problem. Imagery rescripting followed for past aversive memories that were associated with the onset (e.g. bullying). The behaviours were aimed at either (1) threat detection and monitoring or (2) preventing feared consequences by avoidance or (3) attempts to undo the appearance concerns. The therapist aimed to help individuals identify their beliefs about processes, conduct behavioural experiments that tested out their expectations and to gradually drop the safety-seeking behaviours and test out their fears.
• Non specific CBT
Anxiety Management treatment was provided once a week for 12 weeks, with each session lasting 1 hr. AM was planned to entail a therapeutic alliance, support and homework similar to the CBT group. The rationale provided was that when triggered, the person would experience a threat and negative thoughts about their appearance. This, in turn, would lead to physical symptoms of anxiety and magnify the perceived threat. The treatment consisted of (1) practising progressive muscle relaxation and breathing daily, (2) identifying triggers and physical symptoms associated with appearance-related anxiety and (3) utilising brief muscle relaxation and breathing techniques in trigger situations.

Locations

Country	Name	City	State
United Kingdom	South London and Maudsley NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Psychiatry, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997)	This is a clinician-rated scale administered by a trained blinded assessor. The range is 0-48. Cronbach's a for the scale is 0.80. Response to treatment is defined as a 30% or greater decrease in the total BDD-YBOCS score, which best corresponded to 'much improved' on the Clinical Global Impression (CGI) scale. In the original validation study, this cutoff score produced 1 false negative (96% sensitivity), that is, 1 participant who was rated as much or very much improved on the CGI was not classified as a responder on the BDD-YBOCS using the 30% threshold.	12 weeks, 1 month post treatment	No
Secondary	Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)	BABS is a 7-item clinician scale rated by a blinded assessor to measure the strength of conviction in a belief (e.g. 'I am as ugly as the Elephant man'); each item is rated from 0 ('non-delusional belief, or least pathological') to 4 ('delusional belief, or most pathological') and the total scores range from 0 to 24; higher scores represent an increasing delusionality of beliefs; respondents are classified as having delusional BDD beliefs if their total score is 18 or more, and if they score 4 on the first item, indicating they are completely convinced that their belief is accurate.	12 weeks, 1 month post treatment	No
Secondary	Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).	MADRS is a 10-item clinician scale rated by a blinded assessor to measure symptoms of depression; each item is rated on a 7-point Likert scale from 0 (indicating 'normal' or 'no difficulties') to 6, and the range is 0-60; higher scores reflect a greater symptomatology; a MADRS total score of = 25 is regarded as moderate, and of >31 as severe.	12 weeks, 1 month post treatment	No
Secondary	Appearance Anxiety Inventory (AAI)	The AAI is a 10- item self-report questionnaire for measuring the frequency of avoidance behaviour and threat-monitoring (e.g. checking, self-focussed attention) that are characteristic of a response to a distorted body image; each item is scored from 0 ('not at all') to 4 ('all the time'), and the range of the total scores is 0-40, with higher scores reflecting a greater frequency of the responses; the AAI has a Cronbach's a of 0.86.	12 weeks, 1 month post treatment	No
Secondary	Patient Health Questionnaire (PHQ)-9	The PHQ is a 9-item self-report measure of depression; each item is scored from 0 ('not at all') to 3 ('nearly every day'),and the summed total score ranges from 0 to 27, with higher scores reflecting a greater symptomatology of depression; Cronbach's a for the scale is 0.89.	12 weeks, 1 month post treatment	No
Secondary	Generalised Anxiety Disorder (GAD)-7	The GAD-7 is a 7-item self-report measure for symptoms of generalised anxiety; each item is scored from 0 to 3, and the summed total score ranges from 0 to 21, with higher scores reflecting a greater symptomatology; Cronbach's a for the measure is 0.92.	12 weeks,1 month post treatment	No
Secondary	Body Image Quality of Life Inventory (BIQLI)	The BIQLI is a 19-item self-report scale that measures the impact of body image concerns on a broad range of life domains (e.g. sense of self, social functioning, sexuality, emotional well-being, exercise and grooming); the BIQLI is scored as the average numeric score of all the items from -3 ('very negative effect') to +3 ('very positive effect'); Cronbach's a for the scale is 0.95.	12 weeks, 1 month post treatment	No