Body Dysmorphic DisorderNCT03673046
Waitlist-Control Trial of Smartphone Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)
A study testing Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD) in people with Body Dysmorphic Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for body dysmorphic disorder (BDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in body dysmorphic disorder symptom severity than those in the waitlist… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Dysmorphic Disorder
- What is being tested?
- Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2019to 3 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- current diagnosis of primary body dysmorphic disorder (BDD), based on a clinical structured diagnostic interview
- currently living in the United States
Who cannot join
- Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
- Past participation in 4+ sessions of cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)
- Current severe substance use disorder
- Lifetime bipolar disorder or psychosis
- Acute, active suicidal ideation as indicated by clinical judgment and/or a score >2 on the suicidal ideation subscale of the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Current severe comorbid major depression, as indicated by clinical judgment and/or a Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) total score ≥ 21
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- Concurrent psychological treatment
- Does not own a supported Smartphone with a data plan
- Lack of technology literacy that would interfere with ability to engage with smartphone treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Smartphone Cognitive Behavioral Therapy for Body Dysmorphic Disorder: A Randomized, Waitlist-control Trial
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for body dysmorphic disorder (BDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in body dysmorphic disorder symptom severity than those in the waitlist condition at treatment endpoint (week 12).
Read the detailed description
The primary aim of this study is to test the efficacy of a Smartphone-based cognitive behavioral therapy (CBT) treatment for adults with body dysmorphic disorder (BDD) recruited nationally. In a prior study (Clinical Trials Identifier # NCT03221738), the investigators developed and pilot-tested the feasibility, acceptability, and preliminary efficacy of a CBT for BDD app in an open pilot trial. The investigators are now further testing these outcomes in a randomized controlled trial. Eligible subjects (N= 64) will be randomly assigned to 12-weeks of Smartphone-delivered CBT for BDD either immediately, or after a 12-week long waiting period (50/50 chance).
- Conditions
- Body Dysmorphic Disorder
- Being tested
- Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)
- 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.
Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)Device
12-week Smartphone-delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD) | Experimental | 12-week Smartphone-delivered CBT for BDD. Receives: Device: Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD) |
| 12 Week Waitlist Control | Other | 12 week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control). Receives: Device: Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period.
The BDD Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS
Measured: Week 0, Week 6, and Week 12
Secondary outcomes (4)
Difference in Depression at the End of Treatment/Waitlist Period
The self-report Quick Inventory of Depressive Symptomatology (QIDS-SR) is a measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Total scores have a range from 0 to 27 with higher scores indicating greater depression severity. The measure is a well-validated, sensitive measure of symptom severity in depression.
Measured: Week 0, Week 6, and Week 12
Difference in Delusionality at the End of Treatment/Waitlist Period
Delusionality was assessed using the Brown Assessment of Beliefs Scale (BABS). The BABS is a semi-structured, clinician-administered interview that assesses delusional thinking related to one's appearance concerns. It contains 7 items ranging from 0-4; the first six items are summed to generate a total score (range: 0-24). Higher scores indicate greater delusionality.
Measured: Week 0, Week 6, and Week 12
Difference in Functional Impairment at the End of Treatment/Waitlist Period
Functional impairment was measured using the Sheehan Disability Scale (SDS). The SDS is a self-rated, 3-item questionnaire that uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. The 3 items are summed for a total score (range: 0-30), where higher scores indicate greater functional impairment.
Measured: Week 0, Week 6, and Week 12
Difference in Quality of Life at the End of Treatment/Waitlist Period
Quality of life was assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is a 16-item self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100), with higher scores indicating greater quality of life.
Measured: Week 0, Week 6, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start17 Sep 2019
- Primary completion17 Jun 2021
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body Dysmorphic DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Koa Health B.V.
- Responsible party
- Principal investigator, Sabine Wilhelm, PhD, Massachusetts General Hospital
- Investigators
- Sabine Wilhelm, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673046
- Sponsor's protocol ID
- 2017P000293_B
- Status last verified
- Oct 2022
- First submitted
- 11 Sep 2018
- Last updated
- 7 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Weingarden H, Garriga Calleja R, Greenberg JL, Snorrason I, Matic A, Quist R, Harrison O, Hoeppner SS, Wilhelm S. Characterizing observed and effective behavioral engagement with smartphone cognitive behavioral therapy for body dysmorphic disorder: A methods roadmap and use case. Internet Interv. 2023 Mar 16;32:100615. doi: 10.1016/j.invent.2023.100615. eCollection 2023 Apr.
PubMed 36969390
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Cognitive Behavioral Therapy for Body Dysmorphic Disorder: A Randomized, Waitlist-control Trial
- ClinicalTrials.gov ID
- NCT03673046
- Acronym / sponsor ID
- 2017P000293_B
- Conditions
- Body Dysmorphic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Koa Health B.V.
- Study start
- 17 Sep 2019 (actual)
- Primary completion
- 17 Jun 2021 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Posted 14 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for body dysmorphic disorder (BDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in body dysmorphic disorder symptom severity than those in the waitlist condition at treatment endpoint (week 12).
Detailed description
The primary aim of this study is to test the efficacy of a Smartphone-based cognitive behavioral therapy (CBT) treatment for adults with body dysmorphic disorder (BDD) recruited nationally. In a prior study (Clinical Trials Identifier # NCT03221738), the investigators developed and pilot-tested the feasibility, acceptability, and preliminary efficacy of a CBT for BDD app in an open pilot trial. The investigators are now further testing these outcomes in a randomized controlled trial. Eligible subjects (N= 64) will be randomly assigned to 12-weeks of Smartphone-delivered CBT for BDD either immediately, or after a 12-week long waiting period (50/50 chance).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD) | Experimental | Device: Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)12-week Smartphone-delivered CBT for BDD. |
| 12 Week Waitlist Control | Other | Device: Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)12 week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years of age
- current diagnosis of primary body dysmorphic disorder (BDD), based on a clinical structured diagnostic interview
- currently living in the United States
Key exclusion criteria (9 listed)
- Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
- Past participation in 4+ sessions of cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)
- Current severe substance use disorder
- Lifetime bipolar disorder or psychosis
- Acute, active suicidal ideation as indicated by clinical judgment and/or a score >2 on the suicidal ideation subscale of the Columbia-Suicide Severity Rating Scale (C-SSRS).
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 |
|---|---|---|
| Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)12-week Smartphone-delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills. | Device | 12 Week Waitlist Control, Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD) |
Primary outcome
Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period.
Time frame: Week 0, Week 6, and Week 12
The BDD Yale-Brown Obsessive Compulsive Scale (BDD-YBOCS) is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS
4 secondary outcomes
Difference in Depression at the End of Treatment/Waitlist Period
Time frame: Week 0, Week 6, and Week 12
Difference in Delusionality at the End of Treatment/Waitlist Period
Time frame: Week 0, Week 6, and Week 12
Difference in Functional Impairment at the End of Treatment/Waitlist Period
Time frame: Week 0, Week 6, and Week 12
Difference in Quality of Life at the End of Treatment/Waitlist Period
Time frame: Week 0, Week 6, and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36969390Weingarden H, Garriga Calleja R, Greenberg JL, Snorrason I, Matic A, Quist R, Harrison O, Hoeppner SS, Wilhelm S. Characterizing observed and effective behavioral engagement with smartphone cognitive behavioral therapy for body dysmorphic disorder: A methods roadmap and use case. Internet Interv. 2023 Mar 16;32:100615. doi: 10.1016/j.invent.2023.100615. eCollection 2023 Apr.
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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.
Sabine Wilhelm, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD) in people with Body Dysmorphic Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. 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: finished, as of the sponsor's last update on 7 Oct 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period. (time frame: Week 0, Week 6, and Week 12). 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 NCT03673046, which also lists 1 linked publication.
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 Oct 2022.