NCT01316627

Brief Summary

Body Dysmorphic Disorder (BDD) is a disabling condition that until recently has been largely ignored. Sufferers of BDD worry excessively and unreasonably about some flaw in their appearance that may be minimal or even nonexistent. These internalized body image distortions prompt sufferers to constantly check the perceived defects in mirrors, seek reassurance of their images from others, obtain unnecessary cosmetic and/or dermatological procedures, and even conduct self-surgeries. These obsessive concerns and compulsive behaviors cause significant emotional distress and often significantly interfere with global functioning. Currently, cognitive-behavioral therapy (CBT) in conjunction with psychopharmacology is the preferred treatment for BDD. In addition, two relatively new exposure techniques ("mirror retraining method" and "crooked mirror externalization therapy") that utilize mirrors to exaggerate the patient's imagined defect appear to increase the benefits of CBT. However, the treatment efficacies of these relatively novel methods have not been rigorously tested or methodologically compared. Although six out of seven patients treated with crooked mirror externalization therapy at the Westwood Institute for Anxiety Disorders, Inc. demonstrated significant gains, the small sample size does not allow for any significant generalizations. Thus, the goals of this project are: 1) to determine the efficacy of exposure therapy that utilizes mirrors in the treatment of BDD, and 2) to evaluate the level of effectiveness of the mirror retraining method versus the crooked mirror externalization therapy. To accomplish these goals, each subject taking part in the study will do the following. They will go through an in-depth interview with the study physician, Dr. Kagan, and complete several clinical assessment questionnaires to confirm that they have BDD according to the Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV). They will be assessed by the study independent evaluator and complete several paper-and-pencil tests to determine the severity of the BDD and if they have any cognitive difficulties. The subject will participate in 3 weeks of CBT with either the mirror retraining method or the crooked mirror externalization therapy. After the CBT, we will repeat the clinical assessment questionnaires and neurocognitive testing. From the difference between the before and after scores on all these tests, we will determine if there has been any change in the subject's BDD symptoms, and if so, the level of effectiveness between the mirror retraining method and the crooked mirror externalization therapy.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

March 16, 2011

Status Verified

March 1, 2011

Enrollment Period

7.7 years

First QC Date

March 7, 2011

Last Update Submit

March 14, 2011

Conditions

Keywords

Body Dysmorphic Disorder (BDD)Cognitive Behavior Therapy (CBT)Obsessive Compulsive Disorder (OCD)Mirror RetrainingCrooked Mirror Externalization Therapy

Outcome Measures

Primary Outcomes (1)

  • Measure of change in the presence and severity of BDD before and after treatment

    Body Dysmorphic Disorder Modification of the Y-BOCS (BDD-YBOCS); Phillips et al. 1997: A 12-item questionnaire designed to assess for the presence and severity of BDD symptoms.

    Day 1 and at 1 month

Secondary Outcomes (1)

  • Measure of change in the presence and type of BDD symptoms before and after treatment

    Day 1 and at 1 month

Study Arms (2)

Crooked Mirror Externalization Therapy

EXPERIMENTAL

Of recent, the "crooked mirror" externalization therapy, developed by Dr. Eda Gorbis, has been put to use with much success (Gorbis 2004). This method involves the use of crooked or "fun house" mirrors made from highly reflective surfaces that can be bent in different directions, which distort and exaggerate the patient's perceived defects (Gorbis 2005). In turn, this process externalizes or reverses the patient's internalized distorted body image, and allows the patient to habituate to the reflection of the imagined defect that is even more distorted than the internalized image (Rosen et al. 1995).

Behavioral: Crooked Mirror Externalization Therapy

Mirror Retraining Method

ACTIVE COMPARATOR

In treating BDD, the cognitive-behavioral technique, "mirror retraining," uses ordinary and/or magnifying mirrors to amplify the supposed defect, which teaches patients to see their appearance in a more holistic way. Since BDD patients tend to only focus on their perceived flaws when looking in the mirror, and tend to think about their flaws in negative terms, in mirror retraining, patients learn how to change their negative evaluations of their appearance into more objective and nonjudgmental descriptions. Generally, this method is designed to intentionally exaggerate anxiety regarding appearance concerns through exposures with mirrors. However, using exclusively ordinary and/or magnifying mirrors does not address the internal distorted image that many patients with BDD experience (Rosen et al. 1995, Osman et al. 2004, Veale 2004).

Behavioral: Mirror Retraining Method

Interventions

After subjects complete the pre-treatment assessments, the study therapist will meet with participants to design their treatment program. Treatment will be conducted every day for 15 days, Monday through Friday, for 90-minute sessions. In addition, as a part of therapy, subjects will complete homework assignments daily. Intensive CBT for BDD is done in the form of Exposure and Response Prevention (ERP) with either the mirror retraining method or the crooked mirror externalization therapy. This involves prolonged and repeated exposures to images of the perceived defects, and prevention of ritualistic behavior (e.g., camouflaging with cosmetics, skin-picking, etc.).

Also known as: Intensive Cognitive-Behavioral Therapy
Crooked Mirror Externalization Therapy

After subjects complete the pre-treatment assessments, the study therapist will meet with participants to design their treatment program. Treatment will be conducted every day for 15 days, Monday through Friday, for 90-minute sessions. In addition, as a part of therapy, subjects will complete homework assignments daily. Intensive CBT for BDD is done in the form of Exposure and Response Prevention (ERP) with either the mirror retraining method or the crooked mirror externalization therapy. This involves prolonged and repeated exposures to images of the perceived defects, and prevention of ritualistic behavior (e.g., camouflaging with cosmetics, skin-picking, etc.).

Also known as: Intensive Cognitive-Behavioral Therapy
Mirror Retraining Method

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-60
  • Meets DSM-IV criteria for BDD
  • Baseline 12-item BDD-YBOCS score \>15
  • Baseline 33-item BDDE score \> 99
  • Baseline 3-item BDDDM score \> 9
  • IQ \> 90
  • English-speaking
  • No changes in psychotropic medication during or 12 weeks prior to study

You may not qualify if:

  • No medical contraindications
  • No co-morbid psychiatric contraindications (psychosis, bipolar disorder, Tourette's or other tic disorder, panic disorder, PTSD, ADHD, anorexia nervosa, bulimia)
  • Current suicidality
  • Primary diagnosis of OCD, depression, or substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westwood Institute for Anxiety Disorders, Inc.

Los Angeles, California, 90024, United States

RECRUITING

MeSH Terms

Conditions

Body Dysmorphic DisordersObsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Somatoform DisordersMental DisordersAnxiety Disorders

Study Officials

  • Eda Gorbis, PhD, LMFT

    UCLA - DEPARTMENT OF PSYCHIATRY/BIOBEHAVIORAL SCIENCES

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eda Gorbis, PhD, LMFT

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 7, 2011

First Posted

March 16, 2011

Study Start

April 1, 2007

Primary Completion

December 1, 2014

Last Updated

March 16, 2011

Record last verified: 2011-03

Locations