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Completed

NCT Number: NCT04254575

Understanding Daily Changes in BDD Risk Using Smartphones

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.

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Key information

Conditions

Body Dysmorphic Disorders Mental Disorders Somatoform Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

None, observational study only (no interventions)

Other

None, observational study only (no interventions)

Primary outcomes

  1. 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.

  2. 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. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2020
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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