Body Dysmorphic DisorderNCT05402475
Online Cognitive Behavioural Therapy Intervention for Body Dysmorphic Disorder
A study testing CBT + Mindfulness in people with Body Dysmorphic Disorder and Body Image Disturbance, run by York University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Body Dysmorphic Disorder, Body Image Disturbance
- What is being tested?
- CBT + Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
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.
-
Trial locations and contacts
1 site in 1 country.
Camrie Kerry, BA contact
Canada1 site, 1 recruiting
- Recruiting
York University
Toronto, Ontario, M4E 3C1
York University, 4165808021
Paul G Ritvo, PhD, 4165808021 ext. Ritvo, pritvo@yorku.ca
About this study
Official title: Online Cognitive Behavioural Therapy (CBT) Intervention for Body Dysmorphic Disorder: Comparison of CBT - Mindfulness to CBT Alone
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.
- Conditions
- Body Dysmorphic Disorder, Body Image Disturbance
- Being tested
- CBT + Mindfulness
- Keywords
- internet-based intervention with health coaching
- Medical subject headings
- Body Dysmorphic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT + MindfulnessBehavioural
Eight weeks of online CBT intervention combined with mindfulness
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Online cognitive behavioural therapy with the added components of mindfulness meditation Receives: Behavioral: CBT + Mindfulness |
| Active comparator | Active comparator | Online cognitive behavioural therapy alone Receives: Behavioral: CBT + Mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Dysmorphic Disorder Symptom Scale
A 55-item scale which asks for presence/absence of symptoms and the degree of severity
Measured: 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
Measured: Baseline, Post-Intervention at 8 weeks following Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start1 Sep 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Body Dysmorphic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel group randomized clinical trial with two active comparison conditions
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Ritvo, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402475
- Sponsor's protocol ID
- DHRF - 02
- Status last verified
- Jul 2023
- First submitted
- 23 May 2022
- Last updated
- 7 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publication of results
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 34130638Kerry 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.
PubMed 38865704
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Cognitive Behavioural Therapy (CBT) Intervention for Body Dysmorphic Disorder: Comparison of CBT - Mindfulness to CBT Alone
- ClinicalTrials.gov ID
- NCT05402475
- Acronym / sponsor ID
- DHRF - 02
- Conditions
- Body Dysmorphic Disorder, Body Image Disturbance
- Keywords
- internet-based intervention with health coaching
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a parallel group randomized clinical trial with two active comparison conditions
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: CBT + MindfulnessOnline cognitive behavioural therapy with the added components of mindfulness meditation |
| Active comparator | Active comparator | Behavioral: CBT + MindfulnessOnline cognitive behavioural therapy alone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT + MindfulnessEight weeks of online CBT intervention combined with mindfulness | Behavioural | Active comparator, Experimental |
Primary outcome
Body Dysmorphic Disorder Symptom Scale
Time frame: Baseline, Post-Intervention at 8 weeks following Baseline
A 55-item scale which asks for presence/absence of symptoms and the degree of severity
1 secondary outcome
Patient Health Questionnaire - 9
Time frame: Baseline, Post-Intervention at 8 weeks following Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
- Background: PubMed 34130638Kuck 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.
- Derived from this study: PubMed 38865704Kerry 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.
- Individual participant dataSharing planned: No. Publication of results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camrie Kerry, BA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT + Mindfulness in people with Body Dysmorphic Disorder and Body Image Disturbance, run by York University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Ritvo, PhD (4165808021, pritvo@yorku.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Dysmorphic Disorder Symptom Scale (time frame: Baseline, Post-Intervention at 8 weeks following Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05402475, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2023.