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N/A N=10 Treatment

Smartphone-Administered App Treatment for Adults With Body Dysmorphic Disorder

Body Dysmorphic Disorders

Bottom Line

View on ClinicalTrials.gov: NCT03221738 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Treatment Completion Rates — 10 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
App-Based Cognitive Behavioral Therapy (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Jan 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Treatment Completion Rates		 10 —
PRIMARY
Client Satisfaction Questionnaire (CSQ). This Measure Will be Used to Assess Change Over the Course of Treatment Twice Throughout the Study (Over Approximately 10 Months Total).		 27.90 —
SECONDARY
Yale Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS). This Measure Will be Used to Assess Change Over the Course of Treatment at Five Time Points Throughout the Study (Over Approximately 10 Months Total).		 16.50 —

Summary

The investigators are developing and testing a Smartphone-based cognitive behavioral therapy (CBT) "app" for body dysmorphic disorder (BDD). The investigators hypothesize that app-based CBT for BDD will be feasible and acceptable to individuals with BDD, and will improve body image concerns and related outcomes.

Eligibility Criteria

Phase 1B (open pilot trial):

Inclusion Criteria

  • At least 18 years of age
  • Outpatients
  • Meets current diagnosis of primary DSM-5 BDD
  • Has score on BDD-YBOCS of ≥ 20
  • Currently living in the United States

Exclusion Criteria

  • Psychotropic medication changes within 2 months prior to enrollment
  • Participants taking psychotropic medication have to have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period
  • Participated in CBT for BDD ever during lifetime
  • Current substance dependence
  • Lifetime bipolar disorder or psychosis
  • Acute, active suicidal ideation
  • Current severe comorbid major depression, defined by a PHQ-9 total score ≥ 20
  • Personality disorder that could jeopardize treatment participation (e.g., borderline personality disorder with self-harm)
  • Concurrent psychological treatment
  • Do not own a supported mobile Smart phone with a data plan (currently iPhone 5S or more recent, running iOS 9 or newer)
  • Intellectual disability or other cognitive impairment that would interfere with ability to engage in CBT
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03221738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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