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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05402475
Other study ID # DHRF - 02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date November 1, 2023

Study information

Verified date July 2023
Source York University
Contact Paul Ritvo, PhD
Phone 4165808021
Email pritvo@yorku.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date November 1, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Intervention

Behavioral:
CBT + Mindfulness
Eight weeks of online CBT intervention combined with mindfulness

Locations

Country Name City State
Canada York University Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
York University

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other General Anxiety Disorder - 7 A 7-item self report scale that asks for symptoms of anxiety Baseline, Post-Intervention at 8 weeks following Baseline
Other Brief Pain Inventory A 11-item self report scale that asks for symptoms of pain experience Baseline, Post-Intervention at 8 weeks following Baseline
Primary 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 Patient Health Questionnaire - 9 A 9-item self report scale that asks for symptoms of depression and anxiety Baseline, Post-Intervention at 8 weeks following Baseline
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