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

NCT00871143 | Completed Results

• 2 other identifiers: PAXKAYR0
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Dysmorphic Disorder

Keywords

CBT; BDD

Outcome Measures

Primary Outcomes (1)

• 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 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.

  12 weeks, 1 month post treatment

Secondary Outcomes (6)

• Brown Assessment of Beliefs to Measure the Strength of Conviction in Beliefs About Being Ugly (Eisen et al., 1998)

  12 weeks, 1 month post treatment

• Montgomery Asberg Depression Rating Scale (Montgomery and Asberg, 1979).

  12 weeks, 1 month post treatment

• Appearance Anxiety Inventory (AAI)

  12 weeks, 1 month post treatment

• Patient Health Questionnaire (PHQ)-9

  12 weeks, 1 month post treatment

• Generalised Anxiety Disorder (GAD)-7

  12 weeks,1 month post treatment

Study Arms (2)

CBT specific for BDD

EXPERIMENTAL

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

Non Specific CBT

ACTIVE COMPARATOR

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

Interventions

CBT specific for BDD BEHAVIORAL

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.

CBT specific for BDD

Non specific CBT BEHAVIORAL

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.

Non Specific CBT

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institute of Psychiatry, London: lead

Study Sites (1)

South London and Maudsley NHS Trust

London, SE5 8AZ, United Kingdom

Location

Related 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 2014 Oct 16.

  PMID: 25323062 RESULT

MeSH Terms

Conditions

Body Dysmorphic Disorders

Interventions

7,7'-dimethoxy-(4,4'-bi-1,3-benzodioxole)-5,5'-dicarboxylic acid dimethyl ester

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Limitations and Caveats

Small sample size: may have led to difficulty in identifying predictors of outcome. Investigator bias: but testing blinding would be biased as it may be influenced by her rating of the outcome. Treatment too brief to achieve sig. changes in BDD.

Results Point of Contact

• Title: Dr. David Veale
• Organization: Institute of Psychiatry

david.veale@kcl.ac.uk

0203 228 3461

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Psychiatrist

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 30, 2009
• Study Start: April 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: September 1, 2012
• Last Updated: October 6, 2015
• Results First Posted: October 6, 2015

Record last verified: 2015-09

Locations

GB (1)