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Body Dysmorphic DisorderNCT04373629

Perceptual Abnormalities and Their Malleability in BDD

A study testing attentional modulation, perceptual modulation and naturalistic viewing in people with Body Dysmorphic Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A core symptom of body dysmorphic disorder (BDD) is perceptual distortions for appearance, which contributes to poor insight and delusionality, limits engagement in treatment, and puts individuals at risk for relapse. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Body Dysmorphic Disorder
What is being tested?
attentional modulation, perceptual modulation and naturalistic viewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
146 participants
Where
1 siteCanada
Study dates
1 Dec 2020to 1 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Body dysmorphic disorder: Inclusion:
  • males or females
  • ages 18-40
  • meet Diagnostic and Statistical Manual-5 (DSM-5) criteria for Body Dysmorphic Disorder
  • have a Body Dysmorphic Disorder version of the Yale-Brown Obsessive-Compulsive Disorder Scale (BDD-YBOCS) score of ≥20
  • primary appearance concerns of the face or head area
Show all 15Show fewer
  • medication naïve or medication free for at least 8 weeks prior to enrollment
  • Subclinical body dysmorphic disorder: Inclusion:
  • males or females
  • ages 18-40
  • have a score on the Dysmorphic Concern Questionnaire of ≥8 [1 standard deviation (STD) above population norms] - primary appearance concerns of the face or head area
  • medication naïve or medication free for at least 8 weeks prior to enrollment
  • Healthy controls: Inclusion
  • Healthy males and females from any racial or ethnic background - ages 18-40
  • have a score on the Dysmorphic Concern Questionnaire of <8

Who cannot join

  • Body dysmorphic disorder: Exclusion
  • concurrent major Axis I disorders including substance use disorders, aside from anxiety disorders or depressive disorders, as these comorbidities are very common and the sample would otherwise be non-representative; however BDD must be the primary diagnosis.
  • lifetime: bipolar disorder or psychotic disorder.
  • psychotropic medications, aside from a short half-life sedative/hypnotic for insomnia, or a short half-life benzodiazepine as needed for anxiety but not exceeding a frequency of 3 doses in one week and not to be taken on the days of the training or MRI scan
  • current cognitive-behavioral therapy
  • Subclinical body dysmorphic disorder: Exclusion
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  • meet full DSM-5 criteria for Body Dysmorphic Disorder
  • current Axis I disorders including substance use disorders
  • lifetime: bipolar disorder or psychotic disorder
  • psychotropic medications, aside from a short half-life sedative/hypnotic for insomnia, or a short half-life benzodiazepine as needed for anxiety but not exceeding a frequency of 3 doses in one week and not to be taken on the days of the training or MRI scan
  • current cognitive-behavioral therapy
  • Healthy Controls: Exclusion
  • Any current Axis I disorder
  • lifetime: bipolar disorder or psychotic disorder
  • Psychiatric medication
  • All participants: Exclusion
  • Neurological disorder
  • Pregnancy
  • Current major medical disorders that may affect cerebral metabolism such as diabetes or thyroid disorders - Current risk of suicide with a plan and intent
  • Ferromagnetic metal implantations or devices (electronic implants or devices, infusion pumps, aneurysm clips, metal fragments or foreign bodies, metal prostheses, joints, rods or plates)
  • Visual acuity worse than 20/35 for each eye as determined by Snellen close vision acuity chart (vision will be tested with corrective lenses if participant uses them).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Centre for Addiction and Mental Health

    Toronto, Ontario, M6J 1H3

    Jamie D Feusner, M.D., (416) 535-8501 ext. 33436, jamie.feusner@camh.ca

    Jamie D Feusner, M.D.

    Recruiting

Other trials in Canada

About this study

Official title: Neural Mechanisms of Perceptual Abnormalities and Their Malleability in Body Dysmorphic Disorder

A core symptom of body dysmorphic disorder (BDD) is perceptual distortions for appearance, which contributes to poor insight and delusionality, limits engagement in treatment, and puts individuals at risk for relapse. Results from this study will provide a comprehensive mechanistic model of brain, behavioral, and emotional contributors to abnormal perceptual processing, as well as how malleable it is with visual modulation techniques. This will lay the groundwork for next-step translational perceptual retraining approaches.

Read the detailed description

Individuals with body dysmorphic disorder (BDD) misperceive specific aspects of one's own appearance to be conspicuously flawed or defective, despite these being unnoticeable or appearing minuscule to others. With convictions of disfigurement and ugliness, individuals with BDD typically have poor insight or delusional beliefs, obsessive thoughts and compulsive behaviors, anxiety, and depression. These result in significant difficulties in functioning, depression, suicide attempts (25%), and psychiatric hospitalization (50%). Despite this, relatively few studies of the neurobiology, and few treatment studies, have been conducted. This underscores a critical need for research to identify novel targets for intervention based on a comprehensive understanding of the pathophysiological mechanisms. Neuropsychological, behavioral, and neurobiological research by investigators have uncovered mechanisms that may contribute to perceptual distortions, including prominent abnormalities in visual processing systems. These have contributed to a model of diminished global/holistic processing and enhanced local/detailed processing, attributed to "bottom-up" and "top-down" disturbances in perception. Using psychophysical experiments and novel visual modulation techniques, investigators have probed the brain's visual systems responsible for global and local processing and found early evidence that they may be modifiable in BDD. These techniques include a "top-down" attentional modulation and a "bottom-up" perceptual modulation strategy. Abnormal eye gaze and emotional arousal when viewing faces may further contribute to abnormal perception. Whether these brain and behavior abnormalities are directly linked to abnormal perception remains to be understood. Accordingly, this study will determine a) if abnormalities in neural activation and connectivity in BDD when viewing one's own appearance are directly associated with abnormalities in perceptual functioning; and b) if changes in neural activation and connectivity from these visual modulation strategies are linked to changes in perceptual functioning, thus representing potential biomarkers. Investigators will also determine how attentional systems, eye gaze behaviors and emotional arousal interact with brain functioning in visual systems, and with global and local perceptual functioning. Investigators will enroll participants with BDD, with subclinical BDD, and healthy controls who will undergo functional magnetic resonance imaging while viewing photographs of own, and others' faces. Investigators will obtain measures of global and local visual processing, emotional arousal while participants view own face, and eye gaze behaviors using eye tracking. To understand the malleability of global/local perception, and the neural mechanisms of these changes, investigators will determine whether repeated visual modulation using top-down and bottom-up strategies results in alterations of perceptual functioning and brain activity/connectivity, and relationships between them. Results will provide a comprehensive mechanistic model of abnormal visual information processing underlying the core symptom domain of misperceptions of appearance. This will lay the groundwork for next-step translational approaches.

Being tested
attentional modulation, perceptual modulation, naturalistic viewing
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.

  • attentional modulationBehavioural

    Attentional instructions when viewing faces will be given

  • perceptual modulationOther

    Faces will be presented of varying durations

  • naturalistic viewingOther

    Faces will be viewed without specific instructions

Study groups in NCT04373629
Study groupRoleWhat they receive
attention modulationExperimentalNot described
Receives: Behavioral: attentional modulation
perceptual modulationExperimentalNot described
Receives: Other: perceptual modulation
naturalistic viewingExperimentalNot described
Receives: Other: naturalistic viewing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Face inversion effect

    In a force-choice recognition task, participants will view sets of upright target faces followed by 2 upright selection faces, and sets of inverted target faces followed by 2 inverted selection faces. Participants will be instructed to select one of the two faces that is the same as the target face, as quickly and as accurately as possible. The dependent variable is the difference in response times for upright vs. inverted faces.

    Measured: Baseline

  2. Brain connectivity and activation in the dorsal and ventral visual stream

    Investigators will obtain functional magnetic resonance imaging (fMRI) data while participants view photographs of one's face. After preprocessing and analysis investigators will be able to determine: a) baseline associations between brain activity and connectivity and global/ local processing (face inversion effect), and b) associations between changes in brain activity and connectivity with changes in global/local processing (face inversion effect)

    Measured: Baseline

  3. Eye gaze behavior

    Investigators will use eye-tracking for behavioral assessments related to viewing photos of one's face. The primary dependent variable will be mean fixation duration, defined as the mean time that eye gaze is limited to one area (using k-means clustering) across the total viewing duration. We will use an eye-tracker camera to collect data while individuals view photos of one's face. Each face will be 3.5 sec.

    Measured: Baseline

  4. Emotional valence

    Investigators will use automated facial emotional recognition software to calculate valence based on the activity of specific facial landmarks automatically read from video capture of participants while viewing one's own face. The data will be collected simultaneously with the eye-tracking data collection while viewing own faces. The dependent variable of emotional is calculated as the mean, across the entire face viewing, of the intensity of positive emotional expressions minus the intensity of the negative expression with the highest intensity.

    Measured: Baseline

  5. Change in face inversion effect

    In a force-choice recognition task, participants will view sets of upright target faces

    Measured: Within a week after baseline

  6. Change in brain connectivity and activation in the dorsal and ventral visual stream

    Investigators will obtain functional magnetic resonance imaging (fMRI) data while participants view photographs of one's own face. After preprocessing and analysis investigators will be able to determine: a) baseline associations between brain activity and connectivity and global/ local processing (face inversion effect), and b) associations between changes in brain activity and connectivity with changes in global/local processing (face inversion effect)

    Measured: Within a week after baseline

  7. Change in eye gaze behavior

    Investigators will use eye-tracking for behavioral assessments related to viewing photos of one's face. The primary dependent variable will be mean fixation duration, defined as the mean time that eye gaze is limited to one area (using k-means clustering) across the total viewing duration. Investigators will use an eye-tracker camera to collect data while individuals view photos of one's own face. Each face will be 3.5 sec.

    Measured: Within a week after baseline

  8. Change in emotional valence

    Investigators will use automated facial emotional recognition software to calculate valence based on the activity of specific facial landmarks automatically read from video capture of participants while viewing one's own face. The data will be collected simultaneously with the eye-tracking data collection while viewing own faces. The dependent variable of emotional is calculated as the mean, across the entire face viewing, of the intensity of positive emotional expressions minus the intensity of the negative expression with the highest intensity.

    Measured: Within a week after baseline

Secondary outcomes (6)
  1. The body dysmorphic version of the Yale-Brown Obsessive-Compulsive Scale 0-48 values higher score= worse outcome

    This is the most widely used scale to measure BDD symptom severity cross-sectionally, and as a measure of symptom change in treatment studies. It is a clinician-rated scale that consists of 12 items assessing appearance-related obsessions, compulsive behaviors, insight, and avoidance.

    Measured: Baseline

  2. The Brown Assessment of Beliefs Scale 0-24 values higher score= worse outcome

    This clinician-rated scale assesses insight and delusionality related to specific beliefs. It consists of six items that probe one's convictions about their beliefs, if others' agree with their beliefs, attempts to disprove their beliefs, and if their beliefs have psychological or psychiatric causes.

    Measured: Baseline

  3. Body Image States Scale 1-9 values higher the score= better outcome

    This scale consists of six items to assess domains of current body experiences

    Measured: Baseline

  4. Change in the body dysmorphic version of the Yale-Brown Obsessive- Compulsive Scale 0-48 values higher score= worse outcome

    This is the most widely used scale to measure BDD symptom severity cross-sectionally, and as a measure of symptom change in treatment studies. It is a clinician-rated scale that consists of 12 items assessing appearance-related obsessions, compulsive behaviors, insight, and avoidance.

    Measured: 7-10 days after baseline

  5. Change in the Brown Assessment of Beliefs Scale 0-24 values higher score= worse outcome

    This clinician-rated scale assesses insight and delusionality related to specific beliefs. It consists of six items that probe one's convictions about their beliefs, if others' agree with their beliefs, attempts to disprove their beliefs, and if their beliefs have psychological or psychiatric causes.

    Measured: 7-10 days after baseline

  6. Change in the Body Image States Scale 1-9 values higher the score= better outcome

    This scale consists of six items to assess domains of current body experiences

    Measured: 7-10 days after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2020
  2. Study start1 Dec 2020
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
146 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04373629
Sponsor's protocol ID
R01MH121520-01A1
Other IDs
R01MH121520
Status last verified
Nov 2025
First submitted
24 Apr 2020
Last updated
14 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing attentional modulation, perceptual modulation and naturalistic viewing in people with Body Dysmorphic Disorder, run by Centre for Addiction and Mental Health at 1 site in Canada.

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 15 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 14 Nov 2025. 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 Canada. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Research Analyst ((416) 535-8501 ext. 32395, bdd.research@camh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Face inversion effect (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 Nov 2025.

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