Understanding Daily Changes in BDD Risk Using Smartphones

September 19, 2023 updated by: Hilary Weingarden, Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
body dysmorphic disorder (BDD)
Adults with a current primary diagnosis of body dysmorphic disorder (BDD)
Other: None, observational study only (no interventions)
None, observational study only (no interventions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
Time Frame: 3 months
Ecological momentary assessment (EMA) of shame intensity, where higher scores indicate more severe shame.
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)
Time Frame: 3 months
Ecological momentary assessment (EMA)-rated general negative affect intensity, where higher scores indicate more severe negative affect.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Hilary Weingarden, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2020

Primary Completion (Actual)

April 28, 2023

Study Completion (Actual)

April 28, 2023

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019P002041

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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