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Perceptual Abnormalities and Their Malleability in BDD

Primary Purpose

Body Dysmorphic Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
attentional modulation
perceptual modulation
naturalistic viewing
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Body Dysmorphic Disorder

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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
  • medication naïve or medication free for at least 8 weeks prior to enrollment

Inclusion Criteria:

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Exclusion:

Subclinical body dysmorphic disorder: Exclusion

  • 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

Exclusion Criteria:

Healthy Controls: Exclusion

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

Exclusion Criteria:

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).

Sites / Locations

  • Centre for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

attention modulation

perceptual modulation

naturalistic viewing

Arm Description

Outcomes

Primary Outcome Measures

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.
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)
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.
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.
Change in face inversion effect
In a force-choice recognition task, participants will view sets of upright target faces
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)
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.
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.

Secondary Outcome Measures

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.
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.
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
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.
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.
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

Full Information

First Posted
April 24, 2020
Last Updated
October 4, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
National Institute of Mental Health (NIMH), University of Alabama at Birmingham, University of Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04373629
Brief Title
Perceptual Abnormalities and Their Malleability in BDD
Official Title
Neural Mechanisms of Perceptual Abnormalities and Their Malleability in Body Dysmorphic Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
National Institute of Mental Health (NIMH), University of Alabama at Birmingham, University of Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorder

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
attention modulation
Arm Type
Experimental
Arm Title
perceptual modulation
Arm Type
Experimental
Arm Title
naturalistic viewing
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
attentional modulation
Intervention Description
Attentional instructions when viewing faces will be given
Intervention Type
Other
Intervention Name(s)
perceptual modulation
Intervention Description
Faces will be presented of varying durations
Intervention Type
Other
Intervention Name(s)
naturalistic viewing
Intervention Description
Faces will be viewed without specific instructions
Primary Outcome Measure Information:
Title
Face inversion effect
Description
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.
Time Frame
Baseline
Title
Brain connectivity and activation in the dorsal and ventral visual stream
Description
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)
Time Frame
Baseline
Title
Eye gaze behavior
Description
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.
Time Frame
Baseline
Title
Emotional valence
Description
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.
Time Frame
Baseline
Title
Change in face inversion effect
Description
In a force-choice recognition task, participants will view sets of upright target faces
Time Frame
Within a week after baseline
Title
Change in brain connectivity and activation in the dorsal and ventral visual stream
Description
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)
Time Frame
Within a week after baseline
Title
Change in eye gaze behavior
Description
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.
Time Frame
Within a week after baseline
Title
Change in emotional valence
Description
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.
Time Frame
Within a week after baseline
Secondary Outcome Measure Information:
Title
The body dysmorphic version of the Yale-Brown Obsessive-Compulsive Scale 0-48 values higher score= worse outcome
Description
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.
Time Frame
Baseline
Title
The Brown Assessment of Beliefs Scale 0-24 values higher score= worse outcome
Description
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.
Time Frame
Baseline
Title
Body Image States Scale 1-9 values higher the score= better outcome
Description
This scale consists of six items to assess domains of current body experiences
Time Frame
Baseline
Title
Change in the body dysmorphic version of the Yale-Brown Obsessive- Compulsive Scale 0-48 values higher score= worse outcome
Description
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.
Time Frame
7-10 days after baseline
Title
Change in the Brown Assessment of Beliefs Scale 0-24 values higher score= worse outcome
Description
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.
Time Frame
7-10 days after baseline
Title
Change in the Body Image States Scale 1-9 values higher the score= better outcome
Description
This scale consists of six items to assess domains of current body experiences
Time Frame
7-10 days after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 medication naïve or medication free for at least 8 weeks prior to enrollment Inclusion Criteria: 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 Inclusion Criteria: 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 Exclusion Criteria: 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 Exclusion: Subclinical body dysmorphic disorder: Exclusion 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 Exclusion Criteria: Healthy Controls: Exclusion Any current Axis I disorder lifetime: bipolar disorder or psychotic disorder Psychiatric medication Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexis Strazds
Phone
(416) 535-8501
Ext
32395
Email
bdd.research@camh.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Darren Liang
Phone
(416) 535-8501
Ext
39368
Email
darren.liang@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie D Feusner, M.D.
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie D Feusner, M.D.
Phone
(416) 535-8501
Ext
33436
Email
jamie.feusner@camh.ca
First Name & Middle Initial & Last Name & Degree
Jamie D Feusner, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Perceptual Abnormalities and Their Malleability in BDD

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