CClinicalTrials.gg
RecruitingNCT05402475Updated Jul 7, 2023

Online Cognitive Behavioural Therapy Intervention for Body Dysmorphic Disorder

An interventional study of CBT + Mindfulness in Body Dysmorphic Disorder and Body Image Disturbance, sponsored by York University. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2023-07-07.

Sponsored by York University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Body Dysmorphic Disorder
  • Body Image Disturbance

Keywords

  • internet-based intervention with health coaching
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
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.

-

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • BehavioralCBT + Mindfulness

    Eight weeks of online CBT intervention combined with mindfulness

05

What researchers measure

Primary outcomes

  1. Body Dysmorphic Disorder Symptom Scale

    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 outcomes

  1. Patient Health Questionnaire - 9

    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 outcomes

  1. General Anxiety Disorder - 7

    A 7-item self report scale that asks for symptoms of anxiety

    Time frame: Baseline, Post-Intervention at 8 weeks following Baseline

  2. Brief Pain Inventory

    A 11-item self report scale that asks for symptoms of pain experience

    Time frame: Baseline, Post-Intervention at 8 weeks following Baseline

06

Study locations

1 of 1 sites recruiting
  • York University
    Toronto, Ontario M4E 3C1, Canada
    • York University · Contact · 4165808021
    • Paul G Ritvo, PhD · Contact · pritvo@yorku.ca · 4165808021
    • Paul G Ritvo, PhD · Principal investigator
    • Camrie Kerry, BA · Sub investigator
    Recruiting
07

References and documents

Publications

  • 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. PubMed 34130638 ↗

Individual participant data

Plan to share: No — Publication of results

08

Registry details

Key details

Study ID
NCT05402475
Lead sponsor
York University
Responsible party
Paul Ritvo (Professor, York University) — Principal investigator
First posted
Jun 2, 2022
Start date
Sep 1, 2022
Primary completion
Oct 1, 2023 (estimated)
Completion
Nov 1, 2023 (estimated)
Last update
Jul 7, 2023

Study contacts

Paul Ritvo, PhD
Contact
pritvo@yorku.ca
4165808021
Camrie Kerry, BA
Contact
Camrie@yorku.ca

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion