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 ]
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