Attentional Bias in Body Dysmorphic Disorder (VAB)

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Sabine Wilhelm, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT01398904

First received: July 15, 2011

Last updated: August 31, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 15, 2011

Last Updated Date

August 31, 2012

Start Date ^ICMJE

March 2011

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Attention Pattern [ Time Frame: Day 2 ] [ Designated as safety issue: No ]

Gaze tracking via an Eyelink II eye tracker will determine perception of visual information.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01398904 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Subjective Units of Distress Scale (SUDS) [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
Participants will provide a distress score based on the facial images observed.
Facial Attractiveness [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
Using a 9-point Likert scale, participants will rate the perceived most attractive and unattractive feature of their own and the control face.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Attentional Bias in Body Dysmorphic Disorder

Official Title ^ICMJE

Attentional Bias in Body Dysmorphic Disorder

Brief Summary

Body Dysmorphic Disorder (BDD) participants will demonstrate greater attentional biases as compared to healthy control (HC) participants. Greater attention bias will be associated with greater distress. Greater attention bias will be associated with greater symptom severity.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

The study will include 40 participants, consisting of 20 BDD participants and 20 matched healthy controls.

Condition ^ICMJE

Body Dysmorphic Disorders

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Body dysmorphic disorder (BDD) Participants
Participants must be 18 years or older with a primary diagnosis of body dysmorphic disorder (BDD), a BDD Yale-Brown Obsessive Compulsive Scale (BDDY-BOCS) score of >20, and a primary facial/head concern. Participants must have the ability to provide informed consent and understand study staff.
Healthy Controls
Males and females 18 years of age or older with ability to provide informed consent and understand study staff.

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria for BDD and healthy control participants:

males and females 18 years of age or older
sufficient fluency of English to understand study staff, procedures, and questionnaires
ability to provide informed consent

Inclusion for BDD participants only;

primary diagnosis of Diagnostic and Statistical Manual 4th Edition (DSM-IV-TR) BDD
BDD Yale-Brown Obsessive Compulsive Disorder score (Y-BOCS) of > 20
primary facial/head concern

Exclusion Criteria:

Major medical or neurological conditions
schizophrenia, schizoaffective disorder, or any other current lifetime DSM-IV psychotic disorder that is not attributable to delusional BDD
current suicidality
current homicidality

Exclusion criteria for healthy controls:

Any current Axis I psychiatric illness
history of BDD

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01398904

Other Study ID Numbers ^ICMJE

2010P002912

Has Data Monitoring Committee

Responsible Party

Sabine Wilhelm, Massachusetts General Hospital

Study Sponsor ^ICMJE

Massachusetts General Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Sabine Wilhelm, Ph. D.	Massachusetts General Hospital
Study Director:	Jennifer Greenberg, Psy. D.	Massachusetts General Hospital

Information Provided By

Massachusetts General Hospital

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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