Trial Outcomes & Findings for Smartphone-Administered App Treatment for Adults With Body Dysmorphic Disorder (NCT NCT03221738)
NCT ID: NCT03221738
Last Updated: 2019-06-26
Results Overview
Number of subjects who completed the app-based treatment to assess feasibility and acceptability
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Post treatment assessment (12 weeks)
Results posted on
2019-06-26
Participant Flow
Participant milestones
| Measure |
App-Based Cognitive Behavioral Therapy
12-week Smartphone-delivered CBT for BDD.
App-Based Cognitive Behavioral Therapy: 12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
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|---|---|
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Overall Study
STARTED
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10
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Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smartphone-Administered App Treatment for Adults With Body Dysmorphic Disorder
Baseline characteristics by cohort
| Measure |
App-Based Cognitive Behavioral Therapy
n=10 Participants
12-week Smartphone-delivered CBT for BDD.
App-Based Cognitive Behavioral Therapy: 12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
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|---|---|
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Age, Continuous
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27.6 years
STANDARD_DEVIATION 5.66 • n=93 Participants
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Sex: Female, Male
Female
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8 Participants
n=93 Participants
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Sex: Female, Male
Male
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2 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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9 Participants
n=93 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=93 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=93 Participants
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Race (NIH/OMB)
White
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8 Participants
n=93 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=93 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=93 Participants
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PRIMARY outcome
Timeframe: Post treatment assessment (12 weeks)Number of subjects who completed the app-based treatment to assess feasibility and acceptability
Outcome measures
| Measure |
App-Based Cognitive Behavioral Therapy
n=10 Participants
12-week Smartphone-delivered CBT for BDD.
App-Based Cognitive Behavioral Therapy: 12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
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|---|---|
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Treatment Completion Rates
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10 Participants
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PRIMARY outcome
Timeframe: Post-treatment assessment (week 12)The Client Satisfaction Questionnaire (CSQ) is a 25-item self-report questionnaire which assesses the satisfaction with clinical services received. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Outcome measures
| Measure |
App-Based Cognitive Behavioral Therapy
n=10 Participants
12-week Smartphone-delivered CBT for BDD.
App-Based Cognitive Behavioral Therapy: 12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
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|---|---|
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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).
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27.90 score on a scale
Standard Deviation 3.51
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SECONDARY outcome
Timeframe: Post-treatment assessment (week 12)The BDD-YBOCS is the gold-standard, semi-structured clinician-administered assessment of BDD severity. It contains 12 items ranging from 0 to 4, which are summed to generate a total score (range = 0 to 48). Higher scores indicate more severe BDD symptoms. The BDD-YBOCS will be used to assess change in BDD symptoms from baseline to endpoint.
Outcome measures
| Measure |
App-Based Cognitive Behavioral Therapy
n=10 Participants
12-week Smartphone-delivered CBT for BDD.
App-Based Cognitive Behavioral Therapy: 12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
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|---|---|
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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).
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16.50 score on a scale
Standard Deviation 3.63
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Adverse Events
App-Based Cognitive Behavioral Therapy
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
App-Based Cognitive Behavioral Therapy
n=10 participants at risk
12-week Smartphone-delivered CBT for BDD.
App-Based Cognitive Behavioral Therapy: 12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
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|---|---|
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Infections and infestations
Urinary tract infection
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10.0%
1/10 • Number of events 1 • Adverse event data were collected at mid-treatment (6 weeks), post-treatment (12 weeks), 3-month and 6-month follow-up assessment time-points.
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Psychiatric disorders
Depressive symptoms
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30.0%
3/10 • Number of events 3 • Adverse event data were collected at mid-treatment (6 weeks), post-treatment (12 weeks), 3-month and 6-month follow-up assessment time-points.
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Reproductive system and breast disorders
Pap smear
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12.5%
1/8 • Number of events 1 • Adverse event data were collected at mid-treatment (6 weeks), post-treatment (12 weeks), 3-month and 6-month follow-up assessment time-points.
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Reproductive system and breast disorders
Delayed menstrual cycle
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12.5%
1/8 • Number of events 1 • Adverse event data were collected at mid-treatment (6 weeks), post-treatment (12 weeks), 3-month and 6-month follow-up assessment time-points.
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Psychiatric disorders
Increased stress/anxiety
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20.0%
2/10 • Number of events 3 • Adverse event data were collected at mid-treatment (6 weeks), post-treatment (12 weeks), 3-month and 6-month follow-up assessment time-points.
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Reproductive system and breast disorders
Breast lump examination
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10.0%
1/10 • Number of events 1 • Adverse event data were collected at mid-treatment (6 weeks), post-treatment (12 weeks), 3-month and 6-month follow-up assessment time-points.
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General disorders
Wisdom teeth removal
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10.0%
1/10 • Number of events 1 • Adverse event data were collected at mid-treatment (6 weeks), post-treatment (12 weeks), 3-month and 6-month follow-up assessment time-points.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place