Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-02-20 @ 4:46 PM
Study NCT ID:
NCT01398904
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2011-07-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attentional Bias in Body Dysmorphic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057215', 'term': 'Body Dysmorphic Disorders'}], 'ancestors': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-02', 'studyFirstSubmitDate': '2011-07-15', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attention Pattern', 'timeFrame': 'Day 2', 'description': 'Gaze tracking via an Eyelink II eye tracker will determine perception of visual information.'}], 'secondaryOutcomes': [{'measure': 'Subjective Units of Distress Scale (SUDS)', 'timeFrame': 'Day 2', 'description': 'Participants will provide a distress score based on the facial images observed.'}, {'measure': 'Facial Attractiveness', 'timeFrame': 'Day 2', 'description': 'Using a 9-point Likert scale, participants will rate the perceived most attractive and unattractive feature of their own and the control face.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BDD'], 'conditions': ['Body Dysmorphic Disorders']}, 'referencesModule': {'references': [{'pmid': '11011514', 'type': 'BACKGROUND', 'citation': 'Deckersbach T, Savage CR, Phillips KA, Wilhelm S, Buhlmann U, Rauch SL, Baer L, Jenike MA. Characteristics of memory dysfunction in body dysmorphic disorder. J Int Neuropsychol Soc. 2000 Sep;6(6):673-81. doi: 10.1017/s1355617700666055.'}, {'pmid': '10749282', 'type': 'BACKGROUND', 'citation': 'Phillips KA. Quality of life for patients with body dysmorphic disorder. J Nerv Ment Dis. 2000 Mar;188(3):170-5. doi: 10.1097/00005053-200003000-00007.'}, {'pmid': '15960564', 'type': 'BACKGROUND', 'citation': 'Phillips KA, Coles ME, Menard W, Yen S, Fay C, Weisberg RB. Suicidal ideation and suicide attempts in body dysmorphic disorder. J Clin Psychiatry. 2005 Jun;66(6):717-25. doi: 10.4088/jcp.v66n0607.'}, {'pmid': '16175755', 'type': 'BACKGROUND', 'citation': 'Phillips KA, Menard W, Fay C, Pagano ME. Psychosocial functioning and quality of life in body dysmorphic disorder. Compr Psychiatry. 2005 Jul-Aug;46(4):254-60. doi: 10.1016/j.comppsych.2004.10.004.'}, {'pmid': '10202579', 'type': 'BACKGROUND', 'citation': 'Savage CR, Baer L, Keuthen NJ, Brown HD, Rauch SL, Jenike MA. Organizational strategies mediate nonverbal memory impairment in obsessive-compulsive disorder. Biol Psychiatry. 1999 Apr 1;45(7):905-16. doi: 10.1016/s0006-3223(98)00278-9.'}, {'pmid': '20412881', 'type': 'BACKGROUND', 'citation': 'Kelly MM, Walters C, Phillips KA. Social anxiety and its relationship to functional impairment in body dysmorphic disorder. Behav Ther. 2010 Jun;41(2):143-53. doi: 10.1016/j.beth.2009.01.005. Epub 2009 Oct 7.'}, {'pmid': '16231350', 'type': 'BACKGROUND', 'citation': 'Maner JK, Holm-Denoma JM, Van Orden KA, Gailliot MT, Gordon KH, Joiner TE Jr. Evidence for attentional bias in women exhibiting bulimotypic symptoms. Int J Eat Disord. 2006 Jan;39(1):55-61. doi: 10.1002/eat.20222.'}, {'pmid': '18495295', 'type': 'BACKGROUND', 'citation': 'Roefs A, Jansen A, Moresi S, Willems P, van Grootel S, van der Borgh A. Looking good. BMI, attractiveness bias and visual attention. Appetite. 2008 Nov;51(3):552-5. doi: 10.1016/j.appet.2008.04.008. Epub 2008 Apr 15.'}, {'pmid': '15377744', 'type': 'BACKGROUND', 'citation': 'Carey P, Seedat S, Warwick J, van Heerden B, Stein DJ. SPECT imaging of body dysmorphic disorder. J Neuropsychiatry Clin Neurosci. 2004 Summer;16(3):357-9. doi: 10.1176/jnp.16.3.357.'}, {'pmid': '12880191', 'type': 'BACKGROUND', 'citation': 'Janelle CM, Hausenblas HA, Fallon EA, Gardner RE. A visual search examination of attentional biases among individuals with high and low drive for thinness. Eat Weight Disord. 2003 Jun;8(2):138-44. doi: 10.1007/BF03325003.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include 40 participants, consisting of 20 BDD participants and 20 matched healthy controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for BDD and healthy control participants:\n\n* males and females 18 years of age or older\n* sufficient fluency of English to understand study staff, procedures, and questionnaires\n* ability to provide informed consent\n\nInclusion for BDD participants only;\n\n* primary diagnosis of Diagnostic and Statistical Manual 4th Edition (DSM-IV-TR) BDD\n* BDD Yale-Brown Obsessive Compulsive Disorder score (Y-BOCS) of \\> 20\n* primary facial/head concern\n\nExclusion Criteria:\n\n* Major medical or neurological conditions\n* schizophrenia, schizoaffective disorder, or any other current lifetime DSM-IV psychotic disorder that is not attributable to delusional BDD\n* current suicidality\n* current homicidality\n\nExclusion criteria for healthy controls:\n\n* Any current Axis I psychiatric illness\n* history of BDD'}, 'identificationModule': {'nctId': 'NCT01398904', 'acronym': 'VAB', 'briefTitle': 'Attentional Bias in Body Dysmorphic Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Attentional Bias in Body Dysmorphic Disorder', 'orgStudyIdInfo': {'id': '2010P002912'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Body dysmorphic disorder (BDD) Participants', 'description': '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.'}, {'label': 'Healthy Controls', 'description': 'Males and females 18 years of age or older with ability to provide informed consent and understand study staff.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Sabine Wilhelm, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Jennifer Greenberg, Psy. D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, OCD & Related Disorders Program', 'investigatorFullName': 'Sabine Wilhelm', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}