Body Dysmorphic Disorder
Conditions
Brief 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).
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).
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.
Sponsors
Koa Health B.V.
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period. | Week 0, Week 6, and Week 12 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Depression at the End of Treatment/Waitlist Period | Week 0, Week 6, and Week 12 | 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. |
| Difference in Delusionality at the End of Treatment/Waitlist Period | Week 0, Week 6, and Week 12 | 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. |
| Difference in Functional Impairment at the End of Treatment/Waitlist Period | Week 0, Week 6, and Week 12 | 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. |
| Difference in Quality of Life at the End of Treatment/Waitlist Period | Week 0, Week 6, and Week 12 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Smartphone-delivered Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD) 12-week Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD). In-person 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. | 40 |
| Waitlist Control 12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD) following the 12-week waitlist control). | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 2 |
Baseline characteristics
| Characteristic | Waitlist Control | Smartphone-delivered Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD) | Total |
|---|---|---|---|
| Age, Continuous | 26.2 years STANDARD_DEVIATION 9.5 | 27.8 years STANDARD_DEVIATION 9.9 | 27.0 years STANDARD_DEVIATION 9.6 |
| Delusional BDD | 4 Participants | 4 Participants | 8 Participants |
| Duration of body dysmorphic disorder (BDD), years | 12.6 years STANDARD_DEVIATION 11.6 | 14.0 years STANDARD_DEVIATION 9.9 | 13.3 years STANDARD_DEVIATION 10.7 |
| Education 2-year degree / certificate | 4 Participants | 2 Participants | 6 Participants |
| Education College graduate | 11 Participants | 11 Participants | 22 Participants |
| Education High school diploma / General Educational Development (GED) diploma | 5 Participants | 8 Participants | 13 Participants |
| Education Post-graduate / professional degree | 9 Participants | 8 Participants | 17 Participants |
| Education Some college | 7 Participants | 9 Participants | 16 Participants |
| Education Some high school | 1 Participants | 0 Participants | 1 Participants |
| Education Some post-graduate / professional | 3 Participants | 2 Participants | 5 Participants |
| Enrolled after COVID-19 pandemic started | 28 Participants | 28 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 3 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 36 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Marital status Divorced / separated | 3 Participants | 1 Participants | 4 Participants |
| Marital status Living with partner | 2 Participants | 2 Participants | 4 Participants |
| Marital status Married (including Common Law) | 7 Participants | 7 Participants | 14 Participants |
| Marital status Single / never married | 28 Participants | 30 Participants | 58 Participants |
| Number of body parts of concern, mean (standard deviation (SD)) | 11.1 Body parts/participant STANDARD_DEVIATION 6.4 | 11.2 Body parts/participant STANDARD_DEVIATION 6.3 | 11.1 Body parts/participant STANDARD_DEVIATION 6.3 |
| Number of current comorbid MINI diagnoses 1 | 14 Participants | 14 Participants | 28 Participants |
| Number of current comorbid MINI diagnoses 2 | 8 Participants | 8 Participants | 16 Participants |
| Number of current comorbid MINI diagnoses 3 or more | 4 Participants | 5 Participants | 9 Participants |
| Number of current comorbid MINI diagnoses None | 14 Participants | 13 Participants | 27 Participants |
| Race/Ethnicity, Customized Asian | 8 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized Black / African American | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized More than one race | 5 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 22 Participants | 33 Participants | 55 Participants |
| Region of Enrollment United States | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 30 Participants | 37 Participants | 67 Participants |
| Sex: Female, Male Male | 10 Participants | 3 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 19 / 40 | 11 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
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
Population: Data was analyzed in an intent to treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smartphone-delivered CBT for BDD | Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period. | Week 0 | 29.85 score on a scale | Standard Deviation 4.02 |
| Smartphone-delivered CBT for BDD | Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period. | Week 6 | 23.77 score on a scale | Standard Deviation 6.93 |
| Smartphone-delivered CBT for BDD | Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period. | Week 12 | 16.81 score on a scale | Standard Deviation 7.47 |
| Waitlist Control | Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period. | Week 0 | 30.85 score on a scale | Standard Deviation 4.82 |
| Waitlist Control | Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period. | Week 6 | 27.13 score on a scale | Standard Deviation 6.03 |
| Waitlist Control | Difference in BDD Severity (BDD-YBOCS) at the End of Treatment/Waitlist Period. | Week 12 | 26.70 score on a scale | Standard Deviation 6.24 |
Comparison: Null hypothesis: there is no significant difference in BDD-YBOCS total scores between the treatment groups at endpoint (week 12).p-value: <0.000195% CI: [-13.2532, -6.9978]Mixed Models Analysis
Secondary
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
Population: Data was analyzed in an intent to treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smartphone-delivered CBT for BDD | Difference in Delusionality at the End of Treatment/Waitlist Period | Week 0 | 15.10 score on a scale | Standard Deviation 3.25 |
| Smartphone-delivered CBT for BDD | Difference in Delusionality at the End of Treatment/Waitlist Period | Week 6 | 12.26 score on a scale | Standard Deviation 5.25 |
| Smartphone-delivered CBT for BDD | Difference in Delusionality at the End of Treatment/Waitlist Period | Week 12 | 8.30 score on a scale | Standard Deviation 4.98 |
| Waitlist Control | Difference in Delusionality at the End of Treatment/Waitlist Period | Week 0 | 14.45 score on a scale | Standard Deviation 3.43 |
| Waitlist Control | Difference in Delusionality at the End of Treatment/Waitlist Period | Week 6 | 13.50 score on a scale | Standard Deviation 4.75 |
| Waitlist Control | Difference in Delusionality at the End of Treatment/Waitlist Period | Week 12 | 13.22 score on a scale | Standard Deviation 4.88 |
Comparison: Null hypothesis: there is no significant difference in BABS total scores between the treatment groups at endpoint (week 12).p-value: <0.000195% CI: [-7.0698, -2.6126]Mixed Models Analysis
Secondary
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
Population: Data was analyzed in an intent to treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smartphone-delivered CBT for BDD | Difference in Depression at the End of Treatment/Waitlist Period | Week 0 | 11.13 score on a scale | Standard Deviation 4.37 |
| Smartphone-delivered CBT for BDD | Difference in Depression at the End of Treatment/Waitlist Period | Week 6 | 10.15 score on a scale | Standard Deviation 4.77 |
| Smartphone-delivered CBT for BDD | Difference in Depression at the End of Treatment/Waitlist Period | Week 12 | 7.11 score on a scale | Standard Deviation 4.51 |
| Waitlist Control | Difference in Depression at the End of Treatment/Waitlist Period | Week 0 | 11.43 score on a scale | Standard Deviation 3.96 |
| Waitlist Control | Difference in Depression at the End of Treatment/Waitlist Period | Week 6 | 10.08 score on a scale | Standard Deviation 4.74 |
| Waitlist Control | Difference in Depression at the End of Treatment/Waitlist Period | Week 12 | 10.31 score on a scale | Standard Deviation 4.17 |
Comparison: Null hypothesis: there is no significant difference in QIDS-SR total scores between the treatment groups at endpoint (week 12).p-value: 0.002395% CI: [-5.3275, -1.2022]Mixed Models Analysis
Secondary
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
Population: Data was analyzed in an intent to treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smartphone-delivered CBT for BDD | Difference in Functional Impairment at the End of Treatment/Waitlist Period | Week 0 | 15.95 score on a scale | Standard Deviation 6.56 |
| Smartphone-delivered CBT for BDD | Difference in Functional Impairment at the End of Treatment/Waitlist Period | Week 6 | 11.09 score on a scale | Standard Deviation 6.36 |
| Smartphone-delivered CBT for BDD | Difference in Functional Impairment at the End of Treatment/Waitlist Period | Week 12 | 7.64 score on a scale | Standard Deviation 6.78 |
| Waitlist Control | Difference in Functional Impairment at the End of Treatment/Waitlist Period | Week 0 | 17.08 score on a scale | Standard Deviation 6.76 |
| Waitlist Control | Difference in Functional Impairment at the End of Treatment/Waitlist Period | Week 6 | 13.22 score on a scale | Standard Deviation 7.21 |
| Waitlist Control | Difference in Functional Impairment at the End of Treatment/Waitlist Period | Week 12 | 13.49 score on a scale | Standard Deviation 7.31 |
Comparison: Null hypothesis: there is no significant difference in SDS total scores between the treatment groups at endpoint (week 12).p-value: 0.000895% CI: [-9.2237, -2.5458]Mixed Models Analysis
Secondary
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
Population: Data was analyzed in an intent to treat analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Smartphone-delivered CBT for BDD | Difference in Quality of Life at the End of Treatment/Waitlist Period | Week 0 | 52.72 score on a scale | Standard Deviation 16.27 |
| Smartphone-delivered CBT for BDD | Difference in Quality of Life at the End of Treatment/Waitlist Period | Week 6 | 53.99 score on a scale | Standard Deviation 16.42 |
| Smartphone-delivered CBT for BDD | Difference in Quality of Life at the End of Treatment/Waitlist Period | Week 12 | 66.45 score on a scale | Standard Deviation 16.45 |
| Waitlist Control | Difference in Quality of Life at the End of Treatment/Waitlist Period | Week 0 | 48.35 score on a scale | Standard Deviation 10.19 |
| Waitlist Control | Difference in Quality of Life at the End of Treatment/Waitlist Period | Week 6 | 52.12 score on a scale | Standard Deviation 12.25 |
| Waitlist Control | Difference in Quality of Life at the End of Treatment/Waitlist Period | Week 12 | 55.20 score on a scale | Standard Deviation 12.4 |
Comparison: Null hypothesis: there is no significant difference in Q-LESQ-SF total scores between the treatment groups at endpoint (week 12).p-value: 0.001195% CI: [4.863, 18.6428]Mixed Models Analysis