- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05402475
Online Cognitive Behavioural Therapy Intervention for Body Dysmorphic Disorder
Online Cognitive Behavioural Therapy (CBT) Intervention for Body Dysmorphic Disorder: Comparison of CBT - Mindfulness to CBT Alone
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul Ritvo, PhD
- Phone Number: 4165808021
- Email: pritvo@yorku.ca
Study Contact Backup
- Name: Camrie Kerry, BA
- Email: Camrie@yorku.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4E 3C1
- Recruiting
- York University
-
Contact:
- York University
- Phone Number: 4165808021
-
Contact:
- Paul G Ritvo, PhD
- Phone Number: Ritvo 4165808021
- Email: pritvo@yorku.ca
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Principal Investigator:
- Paul G Ritvo, PhD
-
Sub-Investigator:
- Camrie Kerry, BA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DHRF - 02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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