Understanding Daily Changes in BDD Risk Using Smartphones

Completed

• Conditions: Body Dysmorphic Disorders
• Interventions: Other: None, observational study only (no interventions)

• Registration Number: NCT04254575
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-31
• Study First Submitted QC: 2020-01-31
• Study First Posted: 2020-02-05
• Study Start: 2020-07-15
• Primary Completion: 2023-04-28
• Study Completion: 2023-04-28
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-19
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
body dysmorphic disorder (BDD)	None, observational study only (no interventions)	Adults with a current primary diagnosis of body dysmorphic disorder (BDD)

Primary Outcome Measures

Name	Time	Method
Self-reported anxiety intensity, rated from 1 (very slightly or not at all) to 5 (extremely)	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)	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)	3 months	Ecological momentary assessment (EMA)-rated general negative affect intensity, where higher scores indicate more severe negative affect.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States