Clinical Trial: Cognitive Behaviour Therapy (CBT) for Body Dysmorphic Disorder (BDD)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Institute of Psychiatry, London

Current Primary Outcome: Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997) [ Time Frame: 12 weeks, 1 month post treatment ]

This is a clinician-rated scale administered by a trained blinded assessor. The range is 0-48. Cronbach's α 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.


Original Primary Outcome: Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997) [ Time Frame: baseline, 6 weeks, 12 weeks, 1 month post treatment, 3 months post treatment and 1 year post treatment ]

Current Secondary Outcome:

  • Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998) [ Time Frame: 12 weeks, 1 month post treatment ]
    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.
  • Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979). [ Time Frame: 12 weeks, 1 month post treatment ]
    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.
  • Appearance Anxiety Inventory (AAI) [ Time Frame: 12 weeks, 1 month post treatment ]
    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 α of 0.86.
  • Patient Health Questionnaire (PHQ)-9 [ Time Frame: 12 weeks, 1 month post treatment ]
    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 α for the scale is 0.89.
  • Generalised Anxiety Disorder (GAD)-7 [ Time Frame: 12 weeks,1 month post treatment ]
    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 α for the measure is 0.92.
  • Body Image Quality of Life Inventory (BIQLI) [ Time Frame: 12 weeks, 1 month post treatment ]
    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 α for the scale is 0.95.


Original Secondary Outcome:

  • Brown Assessment of Beliefs to measure the strength of conviction in beliefs about being ugly (Eisen et al., 1998) [ Time Frame: baseline, 6 weeks, 12 weeks, 1 month post treatment, 3 months post treatment and 1 year post treatment ]
  • Montgomery Asberg Depression rating scale (Montgomery and Asberg, 1979). There are also five brief self-rated scales [ Time Frame: baseline, 6 weeks, 12 weeks, 1 month post treatment, 3 months post treatment and 1 year post treatment ]


Information By: Institute of Psychiatry, London

Dates:
Date Received: March 27, 2009
Date Started: April 2009
Date Completion:
Last Updated: September 4, 2015
Last Verified: September 2015