Body Dysmorphic DisordersNCT04254575
Understanding Daily Changes in BDD Risk Using Smartphones
An observational study of Body Dysmorphic Disorders, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Body dysmorphic disorder (BDD) is associated with high risk for suicide attempts (22-28%) and substance use disorders (49%), underscoring the importance of accurate, real-time risk detection in BDD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Dysmorphic Disorders
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 28 Apr 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a current primary diagnosis of body dysmorphic disorder (BDD) within the U.S.
Who may be able to join
- Adults age >=18
- Current primary diagnosis of BDD
- BDD severity >= moderate
- Living in US
- English proficiency
- Owns an Android or iOS (Apple) smartphone
- Has regular Wifi-enabled internet access for data downloads
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Smartphone-based Digital Phenotyping to Detect High-risk Affect States in Body Dysmorphic Disorder (BDD)
Body dysmorphic disorder (BDD) is associated with high risk for suicide attempts (22-28%) and substance use disorders (49%), underscoring the importance of accurate, real-time risk detection in BDD. This study aims to use smartphone-based digital phenotyping to develop and validate unobtrusive, time-sensitive, and ecologically valid measures of key risk factors for suicide and substance misuse in BDD: negative affect states. As next steps, this research can be extended to detect risk transdiagnostically, with the goal of enabling just-in-time interventions to target suicide and substance misuse across psychiatric illnesses.
- Conditions
- Body Dysmorphic Disorders
- Being tested
- None, observational study only (no interventions)
- 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.
None, observational study only (no interventions)Other
None, observational study only (no interventions)
| Study group | Role | What they receive |
|---|---|---|
| body dysmorphic disorder (BDD) | Adults with a current primary diagnosis of body dysmorphic disorder (BDD) Receives: Other: None, observational study only (no interventions) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported anxiety intensity, rated from 1 (very slightly or not at all) to 5 (extremely)
Ecological momentary assessment (EMA) of anxiety intensity, where higher scores indicated more severe anxiety.
Measured: 3 months
Self-reported shame intensity, based on Positive and negative affect scale (PANAS) shame item, rated from 1 (very slightly or not at all) to 5 (extremely)
Ecological momentary assessment (EMA) of shame intensity, where higher scores indicate more severe shame.
Measured: 3 months
Self-reported negative affect intensity, based on Positive and negative affect scale (PANAS) negative affect items (averaged), rated from 1 (very slightly or not at all) to 5 (extremely)
Ecological momentary assessment (EMA)-rated general negative affect intensity, where higher scores indicate more severe negative affect.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start15 Jul 2020
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Body Dysmorphic DisordersStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilary Weingarden, Massachusetts General Hospital
- Investigators
- Hilary Weingarden, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254575
- Sponsor's protocol ID
- 2019P002041
- Status last verified
- Sep 2023
- First submitted
- 31 Jan 2020
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Weingarden H, Holstein V, Jonathan GK, Armey M, Onnela JP, Wilhelm S. Low-Burden Detection of Clinical Worsening in Body Dysmorphic Disorder Using Smartphone Sensor and Demographic Data. Behav Ther. 2026 Mar;57(2):220-233. doi: 10.1016/j.beth.2025.09.001. Epub 2025 Sep 11.
PubMed 41741096Weingarden H, Jaroszewski AC, Armey M, Hoeppner BB, Armstrong CH, Onnela JP, Wilhelm S. Predicting concurrent and short-term desire and intent to attempt suicide among people with body dysmorphic disorder using ecological momentary assessment of anxiety and shame. J Psychopathol Clin Sci. 2026 Apr;135(3):403-412. doi: 10.1037/abn0001054. Epub 2025 Oct 6.
PubMed 41051851Weingarden H, Meng X, Armey M, Onnela JP, Jaroszewski A, Armstrong CH, Wilhelm S. Predicting the strength of next-day negative emotion states in body dysmorphic disorder using passive smartphone data: An intensive longitudinal assessment study. Internet Interv. 2025 May 15;40:100833. doi: 10.1016/j.invent.2025.100833. eCollection 2025 Jun.
PubMed 40486130
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-based Digital Phenotyping to Detect High-risk Affect States in Body Dysmorphic Disorder (BDD)
- ClinicalTrials.gov ID
- NCT04254575
- Acronym / sponsor ID
- 2019P002041
- Conditions
- Body Dysmorphic Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 5 Feb 2020 (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) is associated with high risk for suicide attempts (22-28%) and substance use disorders (49%), underscoring the importance of accurate, real-time risk detection in BDD. This study aims to use smartphone-based digital phenotyping to develop and validate unobtrusive, time-sensitive, and ecologically valid measures of key risk factors for suicide and substance misuse in BDD: negative affect states. As next steps, this research can be extended to detect risk transdiagnostically, with the goal of enabling just-in-time interventions to target suicide and substance misuse across psychiatric illnesses.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| body dysmorphic disorder (BDD) | – | Other: None, observational study only (no interventions)Adults with a current primary diagnosis of body dysmorphic disorder (BDD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a current primary diagnosis of body dysmorphic disorder (BDD) within the U.S.
Key inclusion criteria (7 listed)
- Adults age >=18
- Current primary diagnosis of BDD
- BDD severity >= moderate
- Living in US
- English proficiency
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| None, observational study only (no interventions)None, observational study only (no interventions) | Other | body dysmorphic disorder (BDD) |
Primary outcome
Self-reported anxiety intensity, rated from 1 (very slightly or not at all) to 5 (extremely)
Time frame: 3 months
Ecological momentary assessment (EMA) of anxiety intensity, where higher scores indicated more severe anxiety.
Self-reported shame intensity, based on Positive and negative affect scale (PANAS) shame item, rated from 1 (very slightly or not at all) to 5 (extremely)
Time frame: 3 months
Ecological momentary assessment (EMA) of shame intensity, where higher scores indicate more severe shame.
Self-reported negative affect intensity, based on Positive and negative affect scale (PANAS) negative affect items (averaged), rated from 1 (very slightly or not at all) to 5 (extremely)
Time frame: 3 months
Ecological momentary assessment (EMA)-rated general negative affect intensity, where higher scores indicate more severe negative affect.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 41741096Weingarden H, Holstein V, Jonathan GK, Armey M, Onnela JP, Wilhelm S. Low-Burden Detection of Clinical Worsening in Body Dysmorphic Disorder Using Smartphone Sensor and Demographic Data. Behav Ther. 2026 Mar;57(2):220-233. doi: 10.1016/j.beth.2025.09.001. Epub 2025 Sep 11.
- Derived from this study: PubMed 41051851Weingarden H, Jaroszewski AC, Armey M, Hoeppner BB, Armstrong CH, Onnela JP, Wilhelm S. Predicting concurrent and short-term desire and intent to attempt suicide among people with body dysmorphic disorder using ecological momentary assessment of anxiety and shame. J Psychopathol Clin Sci. 2026 Apr;135(3):403-412. doi: 10.1037/abn0001054. Epub 2025 Oct 6.
- Derived from this study: PubMed 40486130Weingarden H, Meng X, Armey M, Onnela JP, Jaroszewski A, Armstrong CH, Wilhelm S. Predicting the strength of next-day negative emotion states in body dysmorphic disorder using passive smartphone data: An intensive longitudinal assessment study. Internet Interv. 2025 May 15;40:100833. doi: 10.1016/j.invent.2025.100833. eCollection 2025 Jun.
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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.
Hilary Weingarden, 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?
An observational study of Body Dysmorphic Disorders, 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 7 inclusion and 0 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 21 Sep 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Self-reported anxiety intensity, rated from 1 (very slightly or not at all) to 5 (extremely) (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT04254575, which also lists 3 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 21 Sep 2023.