Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 2, 2014
Last verified: September 2014
  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, 3 months and 1 year follow up. The main study end-point is at 12 weeks and the secondary end-point is at 3 months and 1 year. 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: baseline, 6 weeks, 12 weeks, 1 month post treatment, 3 months post treatment and 1 year post treatment ] [ Designated as safety issue: No ]

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

Enrollment: 42
Study Start Date: April 2009
Study Completion Date: January 2014
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT specific for BDD Behavioral: CBT specific for BDD
Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
Active Comparator: Non Specific CBT Behavioral: Non specific CBT
CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.

  Eligibility

Ages Eligible for Study:   17 Years to 65 Years
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

No publications provided

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
Last Updated: September 2, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Institute of Psychiatry, London:
CBT
BDD

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

ClinicalTrials.gov processed this record on November 25, 2014