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| Name | Class |
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| Koa Health B.V. | INDUSTRY |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD) | Experimental | 12-week Smartphone-delivered CBT for BDD. |
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| 12 Week Waitlist Control | Other | 12 week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone-delivered cognitive behavioral therapy (CBT) for body dysmorphic disorder (BDD) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 0, Week 6, and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Wilhelm, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36969390 | Derived | Weingarden H, Garriga Calleja R, Greenberg JL, Snorrason I, Matic A, Quist R, Harrison O, Hoeppner SS, Wilhelm S. Characterizing observed and effective behavioral engagement with smartphone cognitive behavioral therapy for body dysmorphic disorder: A methods roadmap and use case. Internet Interv. 2023 Mar 16;32:100615. doi: 10.1016/j.invent.2023.100615. eCollection 2023 Apr. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2022 |
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| Week 0, Week 6, and Week 12 |
| 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. | Week 0, Week 6, and Week 12 |
| 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. | Week 0, Week 6, and Week 12 |
| 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. | Week 0, Week 6, and Week 12 |
| FG001 | 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). |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Education | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| Duration of body dysmorphic disorder (BDD), years | Two participants in the immediate smartphone CBT group had missing data for age of onset of BDD. | Mean | Standard Deviation | years |
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| Number of body parts of concern, mean (standard deviation (SD)) | Participants used a checklist to identify all body parts of concern to them. The number of body parts checked by each participant were summed. | Mean | Standard Deviation | Body parts/participant |
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| Delusional BDD | Delusional beliefs about body dysmorphic disorder were assessed via the Brown Assessment of Beliefs Scale (BABS). Participants were deemed to be delusional if they had a BABS total score of 18 out of a possible total score of 24 in combination with a score of 4 on the first item (conviction). | Count of Participants | Participants |
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| Number of current comorbid MINI diagnoses | The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a short structured diagnostic interview for psychiatric disorders included in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V) and the International Classification of Diseases 10th Revision (ICD-10). Trained clinicians administered the diagnostic interview over approximately 15 minutes to identify whether participants met diagnostic criteria for relatively common (e.g., major depressive disorder) or related (e.g., eating disorders) current and past psychiatric disorders. | Count of Participants | Participants |
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| Enrolled after COVID-19 pandemic started | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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 | Data was analyzed in an intent to treat analysis. | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 6, and Week 12 |
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| 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. | Data was analyzed in an intent to treat analysis. | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 6, and Week 12 |
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| 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. | Data was analyzed in an intent to treat analysis. | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 6, and Week 12 |
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| 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. | Data was analyzed in an intent to treat analysis. | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 6, and Week 12 |
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| 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. | Data was analyzed in an intent to treat analysis. | Posted | Mean | Standard Deviation | score on a scale | Week 0, Week 6, and Week 12 |
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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).
Participants were asked 4 questions about: (1) any major physical health problems or major physical injuries; (2) seeing a physical health or mental health provider for any reason; (3) any hospitalizations; or (4) any other major problems or concerns, all pertaining to the time since they were assessed last. Any "yes" resulted in a full event report. All serious adverse events are reported. Of non-serious events, only those affecting >5% in either treatment group are reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Smartphone-delivered CBT for 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. | 0 | 40 | 0 | 40 | 19 | 40 |
| EG001 | 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). | 0 | 40 | 0 | 40 | 11 | 40 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Increased anxiety or depression | Psychiatric disorders | Systematic Assessment |
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| Suicidal ideation worsening | Psychiatric disorders | Systematic Assessment |
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| Allergies, allergic reactions | Immune system disorders | Systematic Assessment |
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| Injuries and accidents | Injury, poisoning and procedural complications | Systematic Assessment | Shoulder/neck injuries, car accident, broken finger |
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| Procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
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| Migraine | Nervous system disorders | Systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | Systematic Assessment |
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| Medical procedure | Surgical and medical procedures | Systematic Assessment |
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| Other | Psychiatric disorders | Systematic Assessment | panic attack, jaw pain, BDD symptom worsening |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Center for OCD and Related Disorders | Massachusetts General Hospital, Department of Psychiatry | 617-724-6146 | swilhelm@mgh.harvard.edu |
| Jul 21, 2022 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D057215 | Body Dysmorphic Disorders |
| ID | Term |
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| D013001 | Somatoform Disorders |
| D001523 | Mental Disorders |
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