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CompletedNCT03673046Updated Oct 7, 2022Results posted

Waitlist-Control Trial of Smartphone Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)

An interventional study of Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD) in Body Dysmorphic Disorder, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-07.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for body dysmorphic disorder (BDD). The investigators hypothesize that participants receiving app-CBT will have greater improvement in body dysmorphic disorder symptom severity than those in the waitlist condition at treatment endpoint (week 12).

Read the detailed description

The primary aim of this study is to test the efficacy of a Smartphone-based cognitive behavioral therapy (CBT) treatment for adults with body dysmorphic disorder (BDD) recruited nationally. In a prior study (Clinical Trials Identifier # NCT03221738), the investigators developed and pilot-tested the feasibility, acceptability, and preliminary efficacy of a CBT for BDD app in an open pilot trial. The investigators are now further testing these outcomes in a randomized controlled trial. Eligible subjects (N= 64) will be randomly assigned to 12-weeks of Smartphone-delivered CBT for BDD either immediately, or after a 12-week long waiting period (50/50 chance).

02

Conditions studied

  • Body Dysmorphic Disorder
03

In context

Body Dysmorphic Disorders

56 studies on the registry are indexed under Body Dysmorphic Disorders; 11 are open to participants now.

This study's enrollment of 80 is above the median of 52 across 44 interventional studies indexed under Body Dysmorphic Disorders.

Browse Body Dysmorphic Disorders studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.

Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.

Browse Massachusetts General Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • at least 18 years of age
  • current diagnosis of primary body dysmorphic disorder (BDD), based on a clinical structured diagnostic interview
  • currently living in the United States

Exclusion criteria

Exclusion Criteria:

  • Psychotropic medication changes within 2 months prior to enrollment (Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period)
  • Past participation in 4+ sessions of cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)
  • Current severe substance use disorder
  • Lifetime bipolar disorder or psychosis
  • Acute, active suicidal ideation as indicated by clinical judgment and/or a score >2 on the suicidal ideation subscale of the Columbia-Suicide Severity Rating Scale (C-SSRS).
  • Current severe comorbid major depression, as indicated by clinical judgment and/or a Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR) total score ≥ 21
  • Concurrent psychological treatment
  • Does not own a supported Smartphone with a data plan
  • Lack of technology literacy that would interfere with ability to engage with smartphone treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)

    12-week Smartphone-delivered CBT for BDD.

    Device: Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)

  • Other
    12 Week Waitlist Control

    12 week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control).

    Device: Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)

Interventions

  • DeviceSmartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD)

    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.

06

What researchers measure

Primary outcomes

  1. Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period.

    The BDD Yale-Brown Obsessive Compulsive Scale (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

    Time frame: Week 0, Week 6, and Week 12

Secondary outcomes

  1. Difference in Depression at the End of Treatment/Waitlist Period

    The self-report Quick Inventory of Depressive Symptomatology (QIDS-SR) is a measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Total scores have a range from 0 to 27 with higher scores indicating greater depression severity. The measure is a well-validated, sensitive measure of symptom severity in depression.

    Time frame: Week 0, Week 6, and Week 12

  2. Difference in Delusionality at the End of Treatment/Waitlist Period

    Delusionality was assessed using the Brown Assessment of Beliefs Scale (BABS). The BABS is a semi-structured, clinician-administered interview that assesses delusional thinking related to one's appearance concerns. It contains 7 items ranging from 0-4; the first six items are summed to generate a total score (range: 0-24). Higher scores indicate greater delusionality.

    Time frame: Week 0, Week 6, and Week 12

  3. Difference in Functional Impairment at the End of Treatment/Waitlist Period

    Functional impairment was measured using the Sheehan Disability Scale (SDS). The SDS is a self-rated, 3-item questionnaire that uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. The 3 items are summed for a total score (range: 0-30), where higher scores indicate greater functional impairment.

    Time frame: Week 0, Week 6, and Week 12

  4. Difference in Quality of Life at the End of Treatment/Waitlist Period

    Quality of life was assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is a 16-item self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100), with higher scores indicating greater quality of life.

    Time frame: Week 0, Week 6, and Week 12

07

Results

Posted Sep 14, 2022

Participant flow

Participant flow — Overall Study
MilestoneSmartphone-delivered Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)Waitlist Control
Started4040
Completed3137
Not completed93
Withdrew: Adverse event11
Withdrew: Withdrawal by subject82

Outcome measures

PrimaryDifference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period.

The BDD Yale-Brown Obsessive Compulsive Scale (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

Time frame:
Week 0, Week 6, and Week 12
Reported as:
Mean · score on a scale
Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period.
score on a scaleSmartphone-delivered CBT for BDDWaitlist Control
Week 029.85 ± 4.0230.85 ± 4.82
Week 623.77 ± 6.9327.13 ± 6.03
Week 1216.81 ± 7.4726.70 ± 6.24
Statistical analysis
  • Smartphone-delivered CBT for BDD vs Waitlist Control · Mixed Models Analysis · p = <.0001 (The p-value was not adjusted for multiple comparisons because this was the pre-specified primary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.) · Mean difference (final values): -10.1255 · 95% CI -13.2532 to -6.9978The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-eeek waitlist control group outcome at the trial end-point (week 12).
SecondaryDifference in Depression at the End of Treatment/Waitlist Period

The self-report Quick Inventory of Depressive Symptomatology (QIDS-SR) is a measure of depressive symptoms consisting of 16 scale items with responses ranging from 0 to 3, including one suicide item (item #12). Total scores have a range from 0 to 27 with higher scores indicating greater depression severity. The measure is a well-validated, sensitive measure of symptom severity in depression.

Time frame:
Week 0, Week 6, and Week 12
Reported as:
Mean · score on a scale
Difference in Depression at the End of Treatment/Waitlist Period
score on a scaleSmartphone-delivered CBT for BDDWaitlist Control
Week 011.13 ± 4.3711.43 ± 3.96
Week 610.15 ± 4.7710.08 ± 4.74
Week 127.11 ± 4.5110.31 ± 4.17
Statistical analysis
  • Smartphone-delivered CBT for BDD vs Waitlist Control · Mixed Models Analysis · p = 0.0023 (The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.) · Mean difference (final values): -3.2648 · 95% CI -5.3275 to -1.2022The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).
SecondaryDifference in Delusionality at the End of Treatment/Waitlist Period

Delusionality was assessed using the Brown Assessment of Beliefs Scale (BABS). The BABS is a semi-structured, clinician-administered interview that assesses delusional thinking related to one's appearance concerns. It contains 7 items ranging from 0-4; the first six items are summed to generate a total score (range: 0-24). Higher scores indicate greater delusionality.

Time frame:
Week 0, Week 6, and Week 12
Reported as:
Mean · score on a scale
Difference in Delusionality at the End of Treatment/Waitlist Period
score on a scaleSmartphone-delivered CBT for BDDWaitlist Control
Week 015.10 ± 3.2514.45 ± 3.43
Week 612.26 ± 5.2513.50 ± 4.75
Week 128.30 ± 4.9813.22 ± 4.88
Statistical analysis
  • Smartphone-delivered CBT for BDD vs Waitlist Control · Mixed Models Analysis · p = <.0001 (The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.) · Mean difference (final values): -4.8412 · 95% CI -7.0698 to -2.6126The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).
SecondaryDifference in Functional Impairment at the End of Treatment/Waitlist Period

Functional impairment was measured using the Sheehan Disability Scale (SDS). The SDS is a self-rated, 3-item questionnaire that uses a Likert scale from 0 (not at all) to 10 (extremely) to assess impairment in occupational, social, and family domains. The 3 items are summed for a total score (range: 0-30), where higher scores indicate greater functional impairment.

Time frame:
Week 0, Week 6, and Week 12
Reported as:
Mean · score on a scale
Difference in Functional Impairment at the End of Treatment/Waitlist Period
score on a scaleSmartphone-delivered CBT for BDDWaitlist Control
Week 015.95 ± 6.5617.08 ± 6.76
Week 611.09 ± 6.3613.22 ± 7.21
Week 127.64 ± 6.7813.49 ± 7.31
Statistical analysis
  • Smartphone-delivered CBT for BDD vs Waitlist Control · Mixed Models Analysis · p = .0008 (The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.) · Mean difference (final values): -5.8847 · 95% CI -9.2237 to -2.5458The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).
SecondaryDifference in Quality of Life at the End of Treatment/Waitlist Period

Quality of life was assessed using The Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is a 16-item self-report measure of subjective quality of life, containing Likert items ranging from 1 (Very Poor) to 5 (Very Good). Total scores are presented as a percentage of the maximum value (i.e., ranging from 0 to 100), with higher scores indicating greater quality of life.

Time frame:
Week 0, Week 6, and Week 12
Reported as:
Mean · score on a scale
Difference in Quality of Life at the End of Treatment/Waitlist Period
score on a scaleSmartphone-delivered CBT for BDDWaitlist Control
Week 052.72 ± 16.2748.35 ± 10.19
Week 653.99 ± 16.4252.12 ± 12.25
Week 1266.45 ± 16.4555.20 ± 12.40
Statistical analysis
  • Smartphone-delivered CBT for BDD vs Waitlist Control · Mixed Models Analysis · p = .0011 (The p-value was not adjusted for multiple comparisons because this was a pre-specified secondary endpoint comparison. The a priori threshold for statistical significance was alpha=.05.) · Mean difference (final values): 11.7529 · 95% CI 4.8630 to 18.6428The effect is presented as the Smartphone-delivered CBT for BDD group outcome compared to the 12-week waitlist control group outcome at the trial end-point (week 12).

Adverse events

Collected over Adverse event data was collected every 6 weeks after the baseline visit, during the mid-treatment assessment visit (week 6) and the post-treatment visit (week 12). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 6 weeks prior).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Smartphone-delivered CBT for BDD0/40 (0%)0/40 (0%)19/40 (47.5%)
Waitlist Control0/40 (0%)0/40 (0%)11/40 (27.5%)
Most frequent other events
Most frequent other events
EventSmartphone-delivered CBT for BDDWaitlist Control
Increased anxiety or depressionPsychiatric disorders5/401/40
Suicidal ideation worseningPsychiatric disorders5/401/40
Allergies, allergic reactionsImmune system disorders3/402/40
Injuries and accidentsInjury, poisoning and procedural complications3/401/40
OtherPsychiatric disorders0/403/40
Procedural complicationsInjury, poisoning and procedural complications0/402/40
MigraineNervous system disorders2/400/40
EndometriosisReproductive system and breast disorders2/400/40
Medical procedureSurgical and medical procedures2/401/40

Baseline characteristics

Age, Continuous
Age, Continuous(years)Smartphone-delivered Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)Waitlist ControlTotal
Mean27.8 ± 9.926.2 ± 9.527.0 ± 9.6
Sex: Female, Male
Sex: Female, Male(Participants)Smartphone-delivered Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)Waitlist ControlTotal
Female373067
Male31013
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Smartphone-delivered Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)Waitlist ControlTotal
Hispanic or Latino369
Not Hispanic or Latino363470
Unknown or Not Reported101
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Smartphone-delivered Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)Waitlist ControlTotal
White332255
Asian4812
Black / African American022
More than one race358
Other033
Region of Enrollment
Region of Enrollment(participants)Smartphone-delivered Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)Waitlist ControlTotal
United States404080
Education
Education(Participants)Smartphone-delivered Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)Waitlist ControlTotal
Some high school011
High school diploma / General Educational Development (GED) diploma8513
Some college9716
2-year degree / certificate246
College graduate111122
Some post-graduate / professional235
Post-graduate / professional degree8917
Marital status
Marital status(Participants)Smartphone-delivered Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)Waitlist ControlTotal
Single / never married302858
Married (including Common Law)7714
Living with partner224
Divorced / separated134
Duration of body dysmorphic disorder (BDD), years
Duration of body dysmorphic disorder (BDD), years(years)Smartphone-delivered Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)Waitlist ControlTotal
Mean14.0 ± 9.912.6 ± 11.613.3 ± 10.7

4 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03673046
Lead sponsor
Massachusetts General Hospital
Collaborators
Koa Health B.V.
Responsible party
Sabine Wilhelm, PhD (Chief of Psychology, Massachusetts General Hospital) — Principal investigator
First posted
Sep 17, 2018
Start date
Sep 17, 2019
Primary completion
Jun 17, 2021
Completion
Oct 3, 2022
Results posted
Sep 14, 2022
Last update
Oct 7, 2022

Study contacts

Sabine Wilhelm, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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