NCT04254575

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2.8 years

First QC Date

January 31, 2020

Last Update Submit

September 19, 2023

Conditions

Body Dysmorphic Disorders

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    3 months

Study Arms (1)

body dysmorphic disorder (BDD)

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

Other: None, observational study only (no interventions)

Interventions

None, observational study only (no interventions)OTHER

None, observational study only (no interventions)

body dysmorphic disorder (BDD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Weingarden 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. 2025 Oct 6:10.1037/abn0001054. doi: 10.1037/abn0001054. Online ahead of print.

    PMID: 41051851DERIVED

  • Weingarden 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.

    PMID: 40486130DERIVED

MeSH Terms

Conditions

Body Dysmorphic Disorders

Condition Hierarchy (Ancestors)

Somatoform DisordersMental Disorders

Study Officials

  • Hilary Weingarden, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

January 31, 2020

First Posted

February 5, 2020

Study Start

July 15, 2020

Primary Completion

April 28, 2023

Study Completion

April 28, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

US(1)