Understanding Daily Changes in BDD Risk Using Smartphones

Body Dysmorphic Disorders Clinical Trial

Official title:

Smartphone-based Digital Phenotyping to Detect High-risk Affect States in Body Dysmorphic Disorder (BDD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04254575
• Other study ID #: 2019P002041
• Status: Completed
• Start date: July 15, 2020
• Est. completion date: April 28, 2023

Study information

• Verified date: September 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: April 28, 2023
• Est. primary completion date: April 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Body Dysmorphic Disorders

Intervention

Other:
• None, observational study only (no interventions)
None, observational study only (no interventions)

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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