Body Dysmorphic DisordersVABNCT01398904
Attentional Bias in Body Dysmorphic Disorder
An observational study of Body Dysmorphic Disorders, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Body Dysmorphic Disorders
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include 40 participants, consisting of 20 BDD participants and 20 matched healthy controls.
Who may be able to join
- 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
Who cannot join
- 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
- Any current Axis I psychiatric illness
- history of BDD
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Body Dysmorphic Disorders
- Keywords
- BDD
- Medical subject headings
- Body Dysmorphic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention Pattern
Gaze tracking via an Eyelink II eye tracker will determine perception of visual information.
Measured: Day 2
Secondary outcomes (2)
Subjective Units of Distress Scale (SUDS)
Participants will provide a distress score based on the facial images observed.
Measured: Day 2
Facial Attractiveness
Using a 9-point Likert scale, participants will rate the perceived most attractive and unattractive feature of their own and the control face.
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Body Dysmorphic DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabine Wilhelm, Massachusetts General Hospital
- Investigators
- Sabine Wilhelm, Ph. D., Principal investigator, Massachusetts General HospitalJennifer Greenberg, Psy. D., Study director, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398904
- Sponsor's protocol ID
- 2010P002912
- Acronym
- VAB
- Status last verified
- Dec 2014
- First submitted
- 15 Jul 2011
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11011514Phillips 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.
PubMed 10749282Phillips 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.
PubMed 15960564Phillips 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.
PubMed 16175755Savage 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.
PubMed 10202579Kelly 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.
PubMed 20412881Maner 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.
PubMed 16231350Roefs 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.
PubMed 18495295Carey 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.
PubMed 15377744Janelle 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.
PubMed 12880191
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attentional Bias in Body Dysmorphic Disorder
- ClinicalTrials.gov ID
- NCT01398904
- Acronym / sponsor ID
- VAB / 2010P002912
- Conditions
- Body Dysmorphic Disorders
- Keywords
- BDD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 40 participants, consisting of 20 BDD participants and 20 matched healthy controls.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- Any current Axis I psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Attention Pattern
Time frame: Day 2
Gaze tracking via an Eyelink II eye tracker will determine perception of visual information.
2 secondary outcomes
Subjective Units of Distress Scale (SUDS)
Time frame: Day 2
Facial Attractiveness
Time frame: Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2014.
- Background: PubMed 11011514Deckersbach 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.
- Background: PubMed 10749282Phillips 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.
- Background: PubMed 15960564Phillips 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.
- Background: PubMed 16175755Phillips 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.
- Background: PubMed 10202579Savage 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.
- Background: PubMed 20412881Kelly 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.
- Background: PubMed 16231350Maner 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.
- Background: PubMed 18495295Roefs 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.
- Background: PubMed 15377744Carey 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.
- Background: PubMed 12880191Janelle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Wilhelm, Ph. D. principal investigator
Massachusetts General Hospital
Jennifer Greenberg, Psy. D. study director
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Dysmorphic Disorders, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention Pattern (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01398904, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2014.