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CompletedNCT04254575Updated Sep 21, 2023

Understanding Daily Changes in BDD Risk Using Smartphones

An observational study in Body Dysmorphic Disorders, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-21.

Sponsored by Massachusetts General Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
87
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Body Dysmorphic Disorders
03

In context

Body Dysmorphic Disorders

56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.

This study's enrollment of 87 is below the median of 150 across 11 observational studies indexed under Body Dysmorphic Disorders.

Browse Body Dysmorphic Disorders studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adults with a current primary diagnosis of body dysmorphic disorder (BDD) within the U.S.

Eligibility criteria

Inclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
87 participants (actual)
Patient registry
No

Groups and cohorts

  • body dysmorphic disorder (BDD)

    Adults with a current primary diagnosis of body dysmorphic disorder (BDD)

    Other: None, observational study only (no interventions)

Interventions

  • OtherNone, observational study only (no interventions)

    None, observational study only (no interventions)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

  3. 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.

    Time frame: 3 months

07

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2020 to primary completion in Apr 2023, 33 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2020
First posted
Feb 5, 2020
StartActual
Jul 15, 2020
Primary completionActual
Apr 28, 2023
CompletionActual
Apr 28, 2023
Last update
Sep 21, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04254575
Responsible party
Hilary Weingarden (Psychologist, Massachusetts General Hospital) — Principal investigator
First posted
Feb 5, 2020
Start date
Jul 15, 2020
Primary completion
Apr 28, 2023
Completion
Apr 28, 2023
Last update
Sep 21, 2023

Study contacts

Hilary Weingarden, PhD
principal investigator · Massachusetts General Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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