Perceptual Abnormalities and Their Malleability in BDD

NCT04373629 | Recruiting

• 2 other identifiers: R01MH121520-01A1R01MH121520
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Body Dysmorphic Disorder

Outcome Measures

Primary Outcomes (8)

• 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.

  Baseline

• 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)

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• Change in face inversion effect

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

  Within a week after baseline

• 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)

  Within a week after baseline

• 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.

  Within a week after baseline

• 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.

  Within a week after baseline

Secondary Outcomes (6)

• The body dysmorphic version of the Yale-Brown Obsessive-Compulsive Scale 0-48 values higher score= worse outcome

  Baseline

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

  Baseline

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

  Baseline

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

  7-10 days after baseline

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

  7-10 days after baseline

Study Arms (3)

attention modulation

EXPERIMENTAL

Behavioral: attentional modulation

perceptual modulation

EXPERIMENTAL

Other: perceptual modulation

naturalistic viewing

EXPERIMENTAL

Other: naturalistic viewing

Interventions

attentional modulation BEHAVIORAL

Attentional instructions when viewing faces will be given

attention modulation

perceptual modulation OTHER

Faces will be presented of varying durations

perceptual modulation

naturalistic viewing OTHER

Faces will be viewed without specific instructions

naturalistic viewing

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• medication naïve or medication free for at least 8 weeks prior to enrollment
• 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 males and females from any racial or ethnic background - ages 18-40
• have a score on the Dysmorphic Concern Questionnaire of \<8

You may not qualify if:

• 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
• 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
• Any current Axis I disorder
• lifetime: bipolar disorder or psychotic disorder
• Psychiatric medication
• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Alabama at Birmingham: collaborator
• University of Toronto: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H3, Canada

RECRUITING

MeSH Terms

Conditions

Body Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Officials

• Jamie D Feusner, M.D.

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Analyst

CONTACT

(416) 535-8501; bdd.research@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: May 4, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)