Body Dysmorphic DisorderAINCT06584305
AI Screening for BDD in Aesthetic Surgery: Enhancing Safety and Outcomes
An observational study of Body Dysmorphic Disorder, run by Bukret Plastic Surgery at 1 site in Argentina.
Trial summary
The goal of this observational study is to evaluate the effectiveness of an AI-powered screening tool for Body Dysmorphic Disorder (BDD) among patients seeking aesthetic surgery. 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 Disorder
- What is being tested?
- AI-Powered Body Dysmorphic Disorder Screening Procedure
- Type of treatment
- Surgery or procedure
- How many people
- 3,722 participants
- Where
- 1 siteArgentina
- Study dates
- 2 Jan 2021to 23 Aug 2024
- How long will I take part?
- 30 Days
- 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 population includes individuals aged 18 years or older who are seeking elective cosmetic surgery at a private practice in Buenos Aires, Argentina. All participants are required to complete an AI-based Body Dysmorphic Disorder (BDD) screening questionnaire as part of the preoperative evaluation. The study aims to assess the prevalence of BDD and its correlation with various risk factors within this population.
Who may be able to join
- Patients aged 18 years or older
- Completion of the AI-based Body Dysmorphic Disorder Questionnaire (BDDQ)
Who cannot join
- Individuals under the age of 18 years
- Incomplete or refusal to complete the BDDQ
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Intelligence Screening for Body Dysmorphic Disorder in Aesthetic Surgery: Improving Patient Safety and Outcomes
The goal of this observational study is to evaluate the effectiveness of an AI-powered screening tool for Body Dysmorphic Disorder (BDD) among patients seeking aesthetic surgery. The study aims to determine if the AI system can effectively identify patients at risk for BDD and assess the impact of early psychological intervention on surgical decision-making and outcomes. Participants will complete a comprehensive AI-based risk assessment, which includes the Body Dysmorphic Disorder Questionnaire (BDDQ). The study will track the correlation between BDD, age, stress levels, and gender to better understand the prevalence and implications of BDD in cosmetic surgery.
Read the detailed description
This observational study evaluates an AI-powered screening tool for Body Dysmorphic Disorder (BDD) in patients seeking elective aesthetic surgery. The study is designed to assess the effectiveness of the AI system in identifying individuals at risk for BDD, facilitating timely psychological interventions, and improving surgical outcomes.
Study Overview:
Study Population and Inclusion Criteria: Patients aged 18 and older seeking elective cosmetic surgery at a solo practice are included. All participants complete a comprehensive AI-based risk assessment, which includes the Body Dysmorphic Disorder Questionnaire (BDDQ) integrated within the AI system.
AI-Based Risk Assessment: The AI system utilizes data from the BDDQ, along with demographic and psychological factors, to generate a risk score for BDD. This risk score informs the clinical decision-making process, particularly in determining the eligibility for surgery and the need for psychological intervention.
Data Collection and Management: Data is collected through a secure online platform where participants complete the necessary questionnaires. The AI system analyzes the data to generate individualized risk profiles. The study implements rigorous quality assurance processes, including automated data validation checks and source data verification, to ensure the reliability and accuracy of the data.
Statistical Analysis: The study employs correlation analysis to explore the relationships between BDD, age, gender, and stress levels. Chi-square tests are used to assess the statistical significance of differences between demographic groups. The analysis plan includes handling missing data through imputation techniques and conducting sensitivity analyses to validate the robustness of the findings.
Outcome Measures: Primary outcomes include the prevalence of BDD among the study population and the correlations between BDD and key demographic factors. Secondary outcomes focus on the effectiveness of the AI system in enhancing surgical decision-making and improving patient satisfaction.
Ethical Considerations: The study adheres to ethical guidelines, including obtaining informed consent from all participants and anonymizing data to protect privacy. The study is conducted in accordance with the Declaration of Helsinki, and institutional review board approval was deemed unnecessary due to the non-invasive nature of the screening.
Study Limitations: The study acknowledges potential limitations, including the relatively small number of patients who proceeded with surgery, which may affect the generalizability of the findings. Further research is recommended to explore the AI system\'s effectiveness across diverse populations and clinical settings.
- Conditions
- Body Dysmorphic Disorder
- Being tested
- AI-Powered Body Dysmorphic Disorder Screening Procedure
- Keywords
- Body Dysmorphic Disorder, Artificial Intelligence, BDD Screening, Aesthetic Surgery, Cosmetic Surgery, AI-based Risk Assessment, Patient Safety, Psychological Screening, Plastic Surgery, Mental Health in Surgery, prevention
- 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.
AI-Powered Body Dysmorphic Disorder Screening ProcedureProcedure or surgery
The AI-Powered Body Dysmorphic Disorder Screening Procedure involves using an AI tool to evaluate patients for Body Dysmorphic Disorder (BDD) before undergoing elective cosmetic surgery. The screening integrates the Body Dysmorphic Disorder Questionnaire (BDDQ) with additional psychological assessments. The AI system processes the collected data to produce a risk score, guiding surgeons in making informed decisions about the need for psychological evaluation or intervention, and determining the suitability of patients for surgery.
| Study group | Role | What they receive |
|---|---|---|
| AI-Screened Cosmetic Surgery Patients | This cohort consists of patients aged 18 years or older who are undergoing elective cosmetic surgery. All participants in this group have undergone an AI-powered Body Dysmorphic Disorder (BDD) screening, which includes the completion of the Body Dysmorphic Disorder Questionnaire (BDDQ) and additional psychological evaluations. The AI system provides a risk assessment for BDD, guiding the surgical decision-making process and identifying patients who may require psychological intervention before proceeding with surgery. Receives: Procedure: AI-Powered Body Dysmorphic Disorder Screening Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Body Dysmorphic Disorder (BDD) Among Cosmetic Surgery Patients
This outcome measure assesses the prevalence of BDD among patients undergoing cosmetic surgery, as identified through the AI-powered screening tool.
Measured: From 1 to 43 months post-surgery (January 2021 to August 2024)
Secondary outcomes (1)
Correlation Between Positive BDD Screening and Risk Factors
This measure evaluates the correlation between a positive Body Dysmorphic Disorder (BDD) screening result and various risk factors, including demographic factors (age, gender), psychological stress levels, and previous psychiatric history. The goal is to identify patterns that could inform better patient selection and management in cosmetic surgery.
Measured: From 1 to 43 months post-surgery (January 2021 to August 2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start2 Jan 2021
- Primary completion23 Aug 2024
- Study completion23 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Body Dysmorphic DisorderStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,722 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Bukret Plastic Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Williams E Bukret, MD, EMBA, Principal investigator, Bukret Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584305
- Sponsor's protocol ID
- BukretAI-BDD2024
- Acronym
- AI
- Status last verified
- Aug 2024
- First submitted
- 30 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in this study will be shared after de-identification. Data will be available to other researchers upon reasonable request, subject to approval by the principal investigator, Dr. Williams Erik Bukret. The data will be shared through a secure data-sharing platform.
Publications
Singh AR, Veale D. Understanding and treating body dysmorphic disorder. Indian J Psychiatry. 2019 Jan;61(Suppl 1):S131-S135. doi: 10.4103/psychiatry.IndianJPsychiatry_528_18.
PubMed 30745686Jabeen M, Shahzadi M, Hussain A, Unbrin A, Ehsaan S. Evaluating internet-based Cognitive Behavioural Therapy (CBT) for body dysmorphic disorder: A systematic review. J Pak Med Assoc. 2024 Aug;74(8):1488-1494. doi: 10.47391/JPMA.10974.
PubMed 39160718McGrath LR, Oey L, McDonald S, Berle D, Wootton BM. Prevalence of body dysmorphic disorder: A systematic review and meta-analysis. Body Image. 2023 Sep;46:202-211. doi: 10.1016/j.bodyim.2023.06.008. Epub 2023 Jun 21.
PubMed 37352787Panayi A. The Prevalence of Body Dysmorphic Disorder in Patients Undergoing Cosmetic Surgery: a Systematic Review. Psychiatr Danub. 2015 Sep;27 Suppl 1:S438-44.
PubMed 26417812Phillipou A, Rossell SL, Wilding HE, Castle DJ. Randomised controlled trials of psychological & pharmacological treatments for body dysmorphic disorder: A systematic review. Psychiatry Res. 2016 Nov 30;245:179-185. doi: 10.1016/j.psychres.2016.05.062. Epub 2016 Aug 5.
PubMed 27544783Bukret WE. A Novel Artificial Intelligence-assisted Risk Assessment Model for Preventing Complications in Esthetic Surgery. Plast Reconstr Surg Glob Open. 2021 Jul 27;9(7):e3698. doi: 10.1097/GOX.0000000000003698. eCollection 2021 Jul.
PubMed 34422520Veale D, Gledhill LJ, Christodoulou P, Hodsoll J. Body dysmorphic disorder in different settings: A systematic review and estimated weighted prevalence. Body Image. 2016 Sep;18:168-86. doi: 10.1016/j.bodyim.2016.07.003. Epub 2016 Aug 4.
PubMed 27498379
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Screening for Body Dysmorphic Disorder in Aesthetic Surgery: Improving Patient Safety and Outcomes
- ClinicalTrials.gov ID
- NCT06584305
- Acronym / sponsor ID
- AI / BukretAI-BDD2024
- Conditions
- Body Dysmorphic Disorder
- Keywords
- Body Dysmorphic Disorder, Artificial Intelligence, BDD Screening, Aesthetic Surgery, Cosmetic Surgery, AI-based Risk Assessment, Patient Safety, Psychological Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,722 participants (actual)
- Lead sponsor
- Bukret Plastic SurgeryUniversity, hospital or other
- Study start
- 2 Jan 2021 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 4 Sep 2024 (actual)
- 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.
The goal of this observational study is to evaluate the effectiveness of an AI-powered screening tool for Body Dysmorphic Disorder (BDD) among patients seeking aesthetic surgery. The study aims to determine if the AI system can effectively identify patients at risk for BDD and assess the impact of early psychological intervention on surgical decision-making and outcomes. Participants will complete a comprehensive AI-based risk assessment, which includes the Body Dysmorphic Disorder Questionnaire (BDDQ). The study will track the correlation between BDD, age, stress levels, and gender to better understand the prevalence and implications of BDD in cosmetic surgery.
Detailed description
This observational study evaluates an AI-powered screening tool for Body Dysmorphic Disorder (BDD) in patients seeking elective aesthetic surgery. The study is designed to assess the effectiveness of the AI system in identifying individuals at risk for BDD, facilitating timely psychological interventions, and improving surgical outcomes.
Study Overview:
Study Population and Inclusion Criteria: Patients aged 18 and older seeking elective cosmetic surgery at a solo practice are included. All participants complete a comprehensive AI-based risk assessment, which includes the Body Dysmorphic Disorder Questionnaire (BDDQ) integrated within the AI system.
AI-Based Risk Assessment: The AI system utilizes data from the BDDQ, along with demographic and psychological factors, to generate a risk score for BDD. This risk score informs the clinical decision-making process, particularly in determining the eligibility for surgery and the need for psychological intervention.
Data Collection and Management: Data is collected through a secure online platform where participants complete the necessary questionnaires. The AI system analyzes the data to generate individualized risk profiles. The study implements rigorous quality assurance processes, including automated data validation checks and source data verification, to ensure the reliability and accuracy of the data.
Statistical Analysis: The study employs correlation analysis to explore the relationships between BDD, age, gender, and stress levels. Chi-square tests are used to assess the statistical significance of differences between demographic groups. The analysis plan includes handling missing data through imputation techniques and conducting sensitivity analyses to validate the robustness of the findings.
Outcome Measures: Primary outcomes include the prevalence of BDD among the study population and the correlations between BDD and key demographic factors. Secondary outcomes focus on the effectiveness of the AI system in enhancing surgical decision-making and improving patient satisfaction.
Ethical Considerations: The study adheres to ethical guidelines, including obtaining informed consent from all participants and anonymizing data to protect privacy. The study is conducted in accordance with the Declaration of Helsinki, and institutional review board approval was deemed unnecessary due to the non-invasive nature of the screening.
Study Limitations: The study acknowledges potential limitations, including the relatively small number of patients who proceeded with surgery, which may affect the generalizability of the findings. Further research is recommended to explore the AI system\'s effectiveness across diverse populations and clinical settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AI-Screened Cosmetic Surgery Patients | – | Procedure: AI-Powered Body Dysmorphic Disorder Screening ProcedureThis cohort consists of patients aged 18 years or older who are undergoing elective cosmetic surgery. All participants in this group have undergone an AI-powered Body Dysmorphic Disorder (BDD) screening, which includes the completion of the Body Dysmorphic Disorder Questionnaire (BDDQ) and additional psychological evaluations. The AI system provides a risk assessment for BDD, guiding the surgical decision-making process and identifying patients who may require psychological intervention before proceeding with surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes individuals aged 18 years or older who are seeking elective cosmetic surgery at a private practice in Buenos Aires, Argentina. All participants are required to complete an AI-based Body Dysmorphic Disorder (BDD) screening questionnaire as part of the preoperative evaluation. The study aims to assess the prevalence of BDD and its correlation with various risk factors within this population.
Key inclusion criteria (2 listed)
- Patients aged 18 years or older
- Completion of the AI-based Body Dysmorphic Disorder Questionnaire (BDDQ)
Key exclusion criteria (2 listed)
- Individuals under the age of 18 years
- Incomplete or refusal to complete the BDDQ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Powered Body Dysmorphic Disorder Screening ProcedureThe AI-Powered Body Dysmorphic Disorder Screening Procedure involves using an AI tool to evaluate patients for Body Dysmorphic Disorder (BDD) before undergoing elective cosmetic surgery. The screening integrates the Body Dysmorphic Disorder Questionnaire (BDDQ) with additional psychological assessments. The AI system processes the collected data to produce a risk score, guiding surgeons in making informed decisions about the need for psychological evaluation or intervention, and determining the suitability of patients for surgery. | Procedure or surgery | AI-Screened Cosmetic Surgery Patients |
Primary outcome
Prevalence of Body Dysmorphic Disorder (BDD) Among Cosmetic Surgery Patients
Time frame: From 1 to 43 months post-surgery (January 2021 to August 2024)
This outcome measure assesses the prevalence of BDD among patients undergoing cosmetic surgery, as identified through the AI-powered screening tool.
1 secondary outcome
Correlation Between Positive BDD Screening and Risk Factors
Time frame: From 1 to 43 months post-surgery (January 2021 to August 2024)
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 4 Sep 2024.
- Results publication: PubMed 30745686Singh AR, Veale D. Understanding and treating body dysmorphic disorder. Indian J Psychiatry. 2019 Jan;61(Suppl 1):S131-S135. doi: 10.4103/psychiatry.IndianJPsychiatry_528_18.
- Results publication: PubMed 39160718Jabeen M, Shahzadi M, Hussain A, Unbrin A, Ehsaan S. Evaluating internet-based Cognitive Behavioural Therapy (CBT) for body dysmorphic disorder: A systematic review. J Pak Med Assoc. 2024 Aug;74(8):1488-1494. doi: 10.47391/JPMA.10974.
- Results publication: PubMed 37352787McGrath LR, Oey L, McDonald S, Berle D, Wootton BM. Prevalence of body dysmorphic disorder: A systematic review and meta-analysis. Body Image. 2023 Sep;46:202-211. doi: 10.1016/j.bodyim.2023.06.008. Epub 2023 Jun 21.
- Results publication: PubMed 26417812Panayi A. The Prevalence of Body Dysmorphic Disorder in Patients Undergoing Cosmetic Surgery: a Systematic Review. Psychiatr Danub. 2015 Sep;27 Suppl 1:S438-44.
- Results publication: PubMed 27544783Phillipou A, Rossell SL, Wilding HE, Castle DJ. Randomised controlled trials of psychological & pharmacological treatments for body dysmorphic disorder: A systematic review. Psychiatry Res. 2016 Nov 30;245:179-185. doi: 10.1016/j.psychres.2016.05.062. Epub 2016 Aug 5.
- Results publication: PubMed 34422520Bukret WE. A Novel Artificial Intelligence-assisted Risk Assessment Model for Preventing Complications in Esthetic Surgery. Plast Reconstr Surg Glob Open. 2021 Jul 27;9(7):e3698. doi: 10.1097/GOX.0000000000003698. eCollection 2021 Jul.
- Results publication: PubMed 27498379Veale D, Gledhill LJ, Christodoulou P, Hodsoll J. Body dysmorphic disorder in different settings: A systematic review and estimated weighted prevalence. Body Image. 2016 Sep;18:168-86. doi: 10.1016/j.bodyim.2016.07.003. Epub 2016 Aug 4.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in this study will be shared after de-identification. Data will be available to other researchers upon reasonable request, subject to approval by the principal investigator, Dr. Williams Erik Bukret. The data will be shared through a secure data-sharing platform.
Related trials for Body Dysmorphic Disorder
Active, not recruiting
Safety Behavior Fading Versus Progressive Muscle Relaxation for Appearance Concerns
Body Dysmorphic Disorder, Eating Disorders
Not yet recruitingObservational study
Social Media Use and Motherhood
Postpartum Period
Not yet recruiting
Overvaluation of Weight and Shape Intervention vs The Body Project
Body Image, Mental Health Outcomes
RecruitingPhase 2
Study of Dextromethorphan in OCD and Related Disorders
Obsessive-Compulsive Disorder, Illness Anxiety Disorder
Recruiting
Internet-delivered Cognitive-behaviour Therapy for Child and Adolescent Body Dysmorphic Disorder
Body Dysmorphic Disorders
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.
Williams E Bukret, MD, EMBA principal investigator
Bukret Plastic Surgery
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 Disorder, run by Bukret Plastic Surgery at 1 site in Argentina.
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 2 inclusion and 2 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 4 Sep 2024. 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 Argentina. 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?
Prevalence of Body Dysmorphic Disorder (BDD) Among Cosmetic Surgery Patients (time frame: From 1 to 43 months post-surgery (January 2021 to August 2024)). 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 NCT06584305, which also lists 7 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 4 Sep 2024.