NCT06584305

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,722

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2021

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2024

Completed
Last Updated

September 4, 2024

Status Verified

August 1, 2024

Enrollment Period

3.6 years

First QC Date

August 30, 2024

Last Update Submit

August 30, 2024

Conditions

Keywords

Body Dysmorphic DisorderArtificial IntelligenceBDD ScreeningAesthetic SurgeryCosmetic SurgeryAI-based Risk AssessmentPatient SafetyPsychological ScreeningPlastic SurgeryMental Health in Surgeryprevention

Outcome Measures

Primary Outcomes (1)

  • 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.

    From 1 to 43 months post-surgery (January 2021 to August 2024)

Secondary Outcomes (1)

  • Correlation Between Positive BDD Screening and Risk Factors

    From 1 to 43 months post-surgery (January 2021 to August 2024)

Study Arms (1)

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.

Procedure: AI-Powered Body Dysmorphic Disorder Screening Procedure

Interventions

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.

AI-Screened Cosmetic Surgery Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Patients aged 18 years or older
  • Completion of the AI-based Body Dysmorphic Disorder Questionnaire (BDDQ)

You may not qualify if:

  • Individuals under the age of 18 years
  • Incomplete or refusal to complete the BDDQ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bukret Plastic Surgery

Buenos Aires, 1107, Argentina

Location

Related Publications (7)

  • 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.

  • Jabeen 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.

  • McGrath 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.

  • Panayi A. The Prevalence of Body Dysmorphic Disorder in Patients Undergoing Cosmetic Surgery: a Systematic Review. Psychiatr Danub. 2015 Sep;27 Suppl 1:S438-44.

  • Phillipou 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.

  • Bukret 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.

  • Veale 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.

MeSH Terms

Conditions

Body Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Study Officials

  • Williams E Bukret, MD, EMBA

    Bukret Plastic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2024

First Posted

September 4, 2024

Study Start

January 2, 2021

Primary Completion

August 23, 2024

Study Completion

August 23, 2024

Last Updated

September 4, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
IPD and supporting information will be available starting 6 months after publication of the study results and will remain available for 1 year.
Access Criteria
IPD and supporting information will be available to researchers who provide a methodologically sound proposal, which must be approved by the principal investigator, Dr. Williams Erik Bukret. Access will be granted for the purpose of academic research, and the data will be shared through a secure data-sharing platform upon request.
More information

Locations