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Clinical Trials/NCT04254575
NCT04254575CompletedNot Applicable

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

Massachusetts General Hospital1 site in 1 country87 target enrollmentStarted: July 15, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
87
Locations
1
Primary Endpoint
Self-reported anxiety intensity, rated from 1 (very slightly or not at all) to 5 (extremely)

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hilary Weingarden

Psychologist

Massachusetts General Hospital

Study Sites (1)

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