Clinical trial NCT05402475: 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
Overall status: RECRUITING
Phase: NA
Conditions: Body Dysmorphic Disorder
Body Image Disturbance
Keywords: internet-based intervention with health coaching
Lead sponsor: York University
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a parallel group randomized clinical trial with two active comparison conditions
Primary purpose: TREATMENT

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.

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.

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Primary outcomes:
measure: Body Dysmorphic Disorder Symptom Scale
timeFrame: Baseline, Post-Intervention at 8 weeks following Baseline
Secondary outcomes:
measure: Patient Health Questionnaire - 9
timeFrame: Baseline, Post-Intervention at 8 weeks following Baseline
Other outcomes:
measure: General Anxiety Disorder - 7
timeFrame: Baseline, Post-Intervention at 8 weeks following Baseline
measure: Brief Pain Inventory
timeFrame: Baseline, Post-Intervention at 8 weeks following Baseline
Locations:
city: Toronto
country: Canada
facility: York University
state: Ontario
Study officials:
References:
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.