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Online Cognitive Behavioural Therapy Intervention for Body Dysmorphic Disorder

Primary Purpose

Body Dysmorphic Disorder, Body Image Disturbance

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CBT + Mindfulness
Sponsored by
York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Body Dysmorphic Disorder focused on measuring internet-based intervention with health coaching

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

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.

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Sites / Locations

  • York UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Active comparator

Arm Description

Online cognitive behavioural therapy with the added components of mindfulness meditation

Online cognitive behavioural therapy alone

Outcomes

Primary Outcome Measures

Body Dysmorphic Disorder Symptom Scale
A 55-item scale which asks for presence/absence of symptoms and the degree of severity

Secondary Outcome Measures

Patient Health Questionnaire - 9
A 9-item self report scale that asks for symptoms of depression and anxiety

Full Information

First Posted
May 23, 2022
Last Updated
July 4, 2023
Sponsor
York University
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1. Study Identification

Unique Protocol Identification Number
NCT05402475
Brief Title
Online Cognitive Behavioural Therapy Intervention for Body Dysmorphic Disorder
Official Title
Online Cognitive Behavioural Therapy (CBT) Intervention for Body Dysmorphic Disorder: Comparison of CBT - Mindfulness to CBT Alone
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
York University

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Dysmorphic Disorder, Body Image Disturbance
Keywords
internet-based intervention with health coaching

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a parallel group randomized clinical trial with two active comparison conditions
Masking
Participant
Masking Description
Participant will not be informed about which comparison condition to which she has been assigned
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Online cognitive behavioural therapy with the added components of mindfulness meditation
Arm Title
Active comparator
Arm Type
Active Comparator
Arm Description
Online cognitive behavioural therapy alone
Intervention Type
Behavioral
Intervention Name(s)
CBT + Mindfulness
Intervention Description
Eight weeks of online CBT intervention combined with mindfulness
Primary Outcome Measure Information:
Title
Body Dysmorphic Disorder Symptom Scale
Description
A 55-item scale which asks for presence/absence of symptoms and the degree of severity
Time Frame
Baseline, Post-Intervention at 8 weeks following Baseline
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire - 9
Description
A 9-item self report scale that asks for symptoms of depression and anxiety
Time Frame
Baseline, Post-Intervention at 8 weeks following Baseline
Other Pre-specified Outcome Measures:
Title
General Anxiety Disorder - 7
Description
A 7-item self report scale that asks for symptoms of anxiety
Time Frame
Baseline, Post-Intervention at 8 weeks following Baseline
Title
Brief Pain Inventory
Description
A 11-item self report scale that asks for symptoms of pain experience
Time Frame
Baseline, Post-Intervention at 8 weeks following Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Ritvo, PhD
Phone
4165808021
Email
pritvo@yorku.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Camrie Kerry, BA
Email
Camrie@yorku.ca
Facility Information:
Facility Name
York University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4E 3C1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
York University
Phone
4165808021
First Name & Middle Initial & Last Name & Degree
Paul G Ritvo, PhD
Phone
4165808021
Ext
Ritvo
Email
pritvo@yorku.ca
First Name & Middle Initial & Last Name & Degree
Paul G Ritvo, PhD
First Name & Middle Initial & Last Name & Degree
Camrie Kerry, BA

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Publication of results
Citations:
PubMed Identifier
34130638
Citation
Kuck N, Cafitz L, Burkner PC, Hoppen L, Wilhelm S, Buhlmann U. Body dysmorphic disorder and self-esteem: a meta-analysis. BMC Psychiatry. 2021 Jun 15;21(1):310. doi: 10.1186/s12888-021-03185-3.
Results Reference
background

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Online Cognitive Behavioural Therapy Intervention for Body Dysmorphic Disorder

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