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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Veale, Institute of Psychiatry, London
ClinicalTrials.gov Identifier:
NCT00871143
First received: March 27, 2009
Last updated: September 4, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention
Body Dysmorphic Disorder
Behavioral: CBT specific for BDD
Behavioral: Non specific CBT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Cognitive Behaviour Therapy -v- Anxiety Management for Body Dysmorphic Disorder: a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Institute of Psychiatry, London:

Primary Outcome Measures:
  • Yale Brown Obsessive Compulsive Scale (Modified for BDD) (BDD -YBOCS) (Phillips et al., 1997) [ Time Frame: 12 weeks, 1 month post treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 46
Study Start Date: April 2009
Study Completion Date: September 2012
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Active Comparator: 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.
Behavioral: 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.

  Eligibility

Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871143

Locations
United Kingdom
South London and Maudsley NHS Trust
London, United Kingdom, SE5 8AZ
Sponsors and Collaborators
Institute of Psychiatry, London
  More Information

Publications:
Responsible Party: David Veale, Consultant Psychiatrist, Institute of Psychiatry, London
ClinicalTrials.gov Identifier: NCT00871143     History of Changes
Other Study ID Numbers: PAXKAYR  0 
Study First Received: March 27, 2009
Results First Received: April 15, 2015
Last Updated: September 4, 2015
Health Authority: United Kingdom: National Health Service

Keywords provided by Institute of Psychiatry, London:
CBT
BDD

Additional relevant MeSH terms:
Disease
Body Dysmorphic Disorders
Pathologic Processes
Somatoform Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 23, 2016