NCT05402475

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 23, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 7, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

May 23, 2022

Last Update Submit

July 4, 2023

Conditions

Keywords

internet-based intervention with health coaching

Outcome Measures

Primary Outcomes (1)

  • Body Dysmorphic Disorder Symptom Scale

    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 Outcomes (1)

  • Patient Health Questionnaire - 9

    Baseline, Post-Intervention at 8 weeks following Baseline

Other Outcomes (2)

  • General Anxiety Disorder - 7

    Baseline, Post-Intervention at 8 weeks following Baseline

  • Brief Pain Inventory

    Baseline, Post-Intervention at 8 weeks following Baseline

Study Arms (2)

Experimental

EXPERIMENTAL

Online cognitive behavioural therapy with the added components of mindfulness meditation

Behavioral: CBT + Mindfulness

Active comparator

ACTIVE COMPARATOR

Online cognitive behavioural therapy alone

Behavioral: CBT + Mindfulness

Interventions

Eight weeks of online CBT intervention combined with mindfulness

Active comparatorExperimental

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

York University

Toronto, Ontario, M4E 3C1, Canada

RECRUITING

Related Publications (2)

  • 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.

    PMID: 34130638BACKGROUND
  • Kerry C, Mann P, Babaei N, Katz J, Pirbaglou M, Ritvo P. Web-Based Therapist-Guided Mindfulness-Based Cognitive Behavioral Therapy for Body Dysmorphic Disorder: Pilot Randomized Controlled Trial. JMIR Ment Health. 2024 Jun 12;11:e55283. doi: 10.2196/55283.

MeSH Terms

Conditions

Body Dysmorphic Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Paul Ritvo, PhD

CONTACT

Camrie Kerry, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant will not be informed about which comparison condition to which she has been assigned
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a parallel group randomized clinical trial with two active comparison conditions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 23, 2022

First Posted

June 2, 2022

Study Start

September 1, 2022

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

July 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Publication of results

Locations