Online Cognitive Behavioural Therapy Intervention for Body Dysmorphic Disorder

NCT ID: NCT05402475

Last Updated: 2023-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Body Dysmorphic Disorder Body Image Disturbance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a parallel group randomized clinical trial with two active comparison conditions
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participant will not be informed about which comparison condition to which she has been assigned

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

Online cognitive behavioural therapy with the added components of mindfulness meditation

Group Type EXPERIMENTAL

CBT + Mindfulness

Intervention Type BEHAVIORAL

Eight weeks of online CBT intervention combined with mindfulness

Active comparator

Online cognitive behavioural therapy alone

Group Type ACTIVE_COMPARATOR

CBT + Mindfulness

Intervention Type BEHAVIORAL

Eight weeks of online CBT intervention combined with mindfulness

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBT + Mindfulness

Eight weeks of online CBT intervention combined with mindfulness

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

York University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Paul Ritvo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

York University

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Paul Ritvo, PhD

Role: CONTACT

4165808021

Camrie Kerry, BA

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

York University

Role: primary

4165808021

Paul G Ritvo, PhD

Role: backup

4165808021 ext. Ritvo

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 34130638 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38865704 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DHRF - 02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

When The Mirror Is Wrong
NCT07036744 RECRUITING NA
A Single-Component CBT for GAD
NCT02552108 COMPLETED NA