Online Cognitive Behavioural Therapy Intervention for Body Dysmorphic Disorder

July 4, 2023 updated by: Paul Ritvo, York University

Online Cognitive Behavioural Therapy (CBT) Intervention for Body Dysmorphic Disorder: Comparison of CBT - Mindfulness to CBT Alone

Body Dysmorphic Disorder (BDD) affects 2.3% of the population and is characterized by excessive concerns with imagined or minor defects in physical appearance. Retrospective outcome studies suggest patients affected by BDD don't typically benefit from surgical treatments while cognitive behaviour therapy (CBT) appears to provide symptom - reducing and distress - reducing benefits. Two different 8-week online CBT approaches to assisting individuals with this disorder are compared: one approach will integrate mindfulness meditation methods (in combination with CBT) and one approach will employ CBT methods without reference to mindfulness meditation.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

Body Dysmorphic Disorder (BDD) affects 2.3% of the population and is characterized by excessive concerns with imagined or minor defects in physical appearance. Retrospective outcome studies suggest patients affected by BDD typically do not benefit from surgical treatments while cognitive behaviour therapy (CBT) appears to provide symptom - reducing and distress - reducing benefits. In this study two different 8-week online CBT approaches to assist individuals with this disorder are compared: one approach will integrate mindfulness meditation methods (in combination with CBT) and one approach will employ CBT methods without reference to mindfulness meditation.

The purpose of this comparison is to ascertain whether the inclusions of the two additional intervention modalities, demonstrated effective in other studies, adds to positive outcome effects in this disorder. A primary hypothesis is that the 8 week post-intervention outcomes associated with the CBT-mindfulness approach will show significantly more benefit than the comparison group.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M4E 3C1
        • Recruiting
        • York University
        • Contact:
          • York University
          • Phone Number: 4165808021
        • Contact:
        • Principal Investigator:
          • Paul G Ritvo, PhD
        • Sub-Investigator:
          • Camrie Kerry, BA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 28 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: On the Body Dysmorphic Disorder Questionnaire, responses indicating current BDD status; -

Exclusion Criteria: Individuals who are currently receiving weekly structured psychotherapy or who meet DSM-V criteria for severe alcohol/substance use disorder in the past 3 months or demonstrated clinically significant suicidal ideation defined as imminent intent, or attempted suicide in the past 6 months. Individuals of co-morbid diagnoses of borderline personality, schizophrenia, bipolar disorder and/or obsessive compulsive disorder are excluded.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active comparator
Online cognitive behavioural therapy alone
Eight weeks of online CBT intervention combined with mindfulness
Experimental: Experimental
Online cognitive behavioural therapy with the added components of mindfulness meditation
Eight weeks of online CBT intervention combined with mindfulness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body Dysmorphic Disorder Symptom Scale
Time Frame: Baseline, Post-Intervention at 8 weeks following Baseline
A 55-item scale which asks for presence/absence of symptoms and the degree of severity
Baseline, Post-Intervention at 8 weeks following Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire - 9
Time Frame: Baseline, Post-Intervention at 8 weeks following Baseline
A 9-item self report scale that asks for symptoms of depression and anxiety
Baseline, Post-Intervention at 8 weeks following Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
General Anxiety Disorder - 7
Time Frame: Baseline, Post-Intervention at 8 weeks following Baseline
A 7-item self report scale that asks for symptoms of anxiety
Baseline, Post-Intervention at 8 weeks following Baseline
Brief Pain Inventory
Time Frame: Baseline, Post-Intervention at 8 weeks following Baseline
A 11-item self report scale that asks for symptoms of pain experience
Baseline, Post-Intervention at 8 weeks following Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

May 23, 2022

First Submitted That Met QC Criteria

May 30, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 4, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • DHRF - 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Publication of results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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