Trial Outcomes & Findings for Waitlist-Control Trial of Smartphone Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD) (NCT NCT03673046)
NCT ID: NCT03673046
Last Updated: 2022-10-07
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
Week 0, Week 6, and Week 12
Results posted on
2022-10-07
Participant Flow
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
31
|
37
|
|
Overall Study
NOT COMPLETED
|
9
|
3
|
Reasons for withdrawal
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
8
|
2
|
Baseline Characteristics
Two participants in the immediate smartphone CBT group had missing data for age of onset of BDD.
Baseline characteristics by cohort
| Measure |
Smartphone-delivered Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder (BDD)
n=40 Participants
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.
|
Waitlist Control
n=40 Participants
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).
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Delusional BDD
|
4 Participants
n=40 Participants
|
4 Participants
n=40 Participants
|
8 Participants
n=80 Participants
|
|
Number of current comorbid MINI diagnoses
None
|
13 Participants
n=40 Participants
|
14 Participants
n=40 Participants
|
27 Participants
n=80 Participants
|
|
Age, Continuous
|
27.8 years
STANDARD_DEVIATION 9.9 • n=40 Participants
|
26.2 years
STANDARD_DEVIATION 9.5 • n=40 Participants
|
27.0 years
STANDARD_DEVIATION 9.6 • n=80 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=40 Participants
|
30 Participants
n=40 Participants
|
67 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=40 Participants
|
10 Participants
n=40 Participants
|
13 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=40 Participants
|
6 Participants
n=40 Participants
|
9 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=40 Participants
|
34 Participants
n=40 Participants
|
70 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
White
|
33 Participants
n=40 Participants
|
22 Participants
n=40 Participants
|
55 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=40 Participants
|
8 Participants
n=40 Participants
|
12 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Black / African American
|
0 Participants
n=40 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
3 Participants
n=40 Participants
|
5 Participants
n=40 Participants
|
8 Participants
n=80 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=40 Participants
|
3 Participants
n=40 Participants
|
3 Participants
n=80 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=40 Participants
|
40 participants
n=40 Participants
|
80 participants
n=80 Participants
|
|
Education
Some high school
|
0 Participants
n=40 Participants
|
1 Participants
n=40 Participants
|
1 Participants
n=80 Participants
|
|
Education
High school diploma / General Educational Development (GED) diploma
|
8 Participants
n=40 Participants
|
5 Participants
n=40 Participants
|
13 Participants
n=80 Participants
|
|
Education
Some college
|
9 Participants
n=40 Participants
|
7 Participants
n=40 Participants
|
16 Participants
n=80 Participants
|
|
Education
2-year degree / certificate
|
2 Participants
n=40 Participants
|
4 Participants
n=40 Participants
|
6 Participants
n=80 Participants
|
|
Education
College graduate
|
11 Participants
n=40 Participants
|
11 Participants
n=40 Participants
|
22 Participants
n=80 Participants
|
|
Education
Some post-graduate / professional
|
2 Participants
n=40 Participants
|
3 Participants
n=40 Participants
|
5 Participants
n=80 Participants
|
|
Education
Post-graduate / professional degree
|
8 Participants
n=40 Participants
|
9 Participants
n=40 Participants
|
17 Participants
n=80 Participants
|
|
Marital status
Single / never married
|
30 Participants
n=40 Participants
|
28 Participants
n=40 Participants
|
58 Participants
n=80 Participants
|
|
Marital status
Married (including Common Law)
|
7 Participants
n=40 Participants
|
7 Participants
n=40 Participants
|
14 Participants
n=80 Participants
|
|
Marital status
Living with partner
|
2 Participants
n=40 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=80 Participants
|
|
Marital status
Divorced / separated
|
1 Participants
n=40 Participants
|
3 Participants
n=40 Participants
|
4 Participants
n=80 Participants
|
|
Duration of body dysmorphic disorder (BDD), years
|
14.0 years
STANDARD_DEVIATION 9.9 • n=38 Participants • Two participants in the immediate smartphone CBT group had missing data for age of onset of BDD.
|
12.6 years
STANDARD_DEVIATION 11.6 • n=40 Participants • Two participants in the immediate smartphone CBT group had missing data for age of onset of BDD.
|
13.3 years
STANDARD_DEVIATION 10.7 • n=78 Participants • Two participants in the immediate smartphone CBT group had missing data for age of onset of BDD.
|
|
Number of body parts of concern, mean (standard deviation (SD))
|
11.2 Body parts/participant
STANDARD_DEVIATION 6.3 • n=40 Participants
|
11.1 Body parts/participant
STANDARD_DEVIATION 6.4 • n=40 Participants
|
11.1 Body parts/participant
STANDARD_DEVIATION 6.3 • n=80 Participants
|
|
Number of current comorbid MINI diagnoses
1
|
14 Participants
n=40 Participants
|
14 Participants
n=40 Participants
|
28 Participants
n=80 Participants
|
|
Number of current comorbid MINI diagnoses
2
|
8 Participants
n=40 Participants
|
8 Participants
n=40 Participants
|
16 Participants
n=80 Participants
|
|
Number of current comorbid MINI diagnoses
3 or more
|
5 Participants
n=40 Participants
|
4 Participants
n=40 Participants
|
9 Participants
n=80 Participants
|
|
Enrolled after COVID-19 pandemic started
|
28 Participants
n=40 Participants
|
28 Participants
n=40 Participants
|
56 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 6, and Week 12Population: Data was analyzed in an intent to treat analysis.
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
Outcome measures
| Measure |
Smartphone-delivered CBT for BDD
n=40 Participants
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.
|
Waitlist Control
n=40 Participants
12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control).
|
|---|---|---|
|
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
|
30.85 score on a scale
Standard Deviation 4.82
|
|
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
|
27.13 score on a scale
Standard Deviation 6.03
|
|
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
|
26.70 score on a scale
Standard Deviation 6.24
|
SECONDARY outcome
Timeframe: Week 0, Week 6, and Week 12Population: Data was analyzed in an intent to treat analysis.
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.
Outcome measures
| Measure |
Smartphone-delivered CBT for BDD
n=40 Participants
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.
|
Waitlist Control
n=40 Participants
12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control).
|
|---|---|---|
|
Difference in Depression at the End of Treatment/Waitlist Period
Week 0
|
11.13 score on a scale
Standard Deviation 4.37
|
11.43 score on a scale
Standard Deviation 3.96
|
|
Difference in Depression at the End of Treatment/Waitlist Period
Week 6
|
10.15 score on a scale
Standard Deviation 4.77
|
10.08 score on a scale
Standard Deviation 4.74
|
|
Difference in Depression at the End of Treatment/Waitlist Period
Week 12
|
7.11 score on a scale
Standard Deviation 4.51
|
10.31 score on a scale
Standard Deviation 4.17
|
SECONDARY outcome
Timeframe: Week 0, Week 6, and Week 12Population: Data was analyzed in an intent to treat analysis.
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.
Outcome measures
| Measure |
Smartphone-delivered CBT for BDD
n=40 Participants
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.
|
Waitlist Control
n=40 Participants
12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control).
|
|---|---|---|
|
Difference in Delusionality at the End of Treatment/Waitlist Period
Week 0
|
15.10 score on a scale
Standard Deviation 3.25
|
14.45 score on a scale
Standard Deviation 3.43
|
|
Difference in Delusionality at the End of Treatment/Waitlist Period
Week 6
|
12.26 score on a scale
Standard Deviation 5.25
|
13.50 score on a scale
Standard Deviation 4.75
|
|
Difference in Delusionality at the End of Treatment/Waitlist Period
Week 12
|
8.30 score on a scale
Standard Deviation 4.98
|
13.22 score on a scale
Standard Deviation 4.88
|
SECONDARY outcome
Timeframe: Week 0, Week 6, and Week 12Population: Data was analyzed in an intent to treat analysis.
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.
Outcome measures
| Measure |
Smartphone-delivered CBT for BDD
n=40 Participants
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.
|
Waitlist Control
n=40 Participants
12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control).
|
|---|---|---|
|
Difference in Functional Impairment at the End of Treatment/Waitlist Period
Week 0
|
15.95 score on a scale
Standard Deviation 6.56
|
17.08 score on a scale
Standard Deviation 6.76
|
|
Difference in Functional Impairment at the End of Treatment/Waitlist Period
Week 6
|
11.09 score on a scale
Standard Deviation 6.36
|
13.22 score on a scale
Standard Deviation 7.21
|
|
Difference in Functional Impairment at the End of Treatment/Waitlist Period
Week 12
|
7.64 score on a scale
Standard Deviation 6.78
|
13.49 score on a scale
Standard Deviation 7.31
|
SECONDARY outcome
Timeframe: Week 0, Week 6, and Week 12Population: Data was analyzed in an intent to treat analysis.
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.
Outcome measures
| Measure |
Smartphone-delivered CBT for BDD
n=40 Participants
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.
|
Waitlist Control
n=40 Participants
12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control).
|
|---|---|---|
|
Difference in Quality of Life at the End of Treatment/Waitlist Period
Week 0
|
52.72 score on a scale
Standard Deviation 16.27
|
48.35 score on a scale
Standard Deviation 10.19
|
|
Difference in Quality of Life at the End of Treatment/Waitlist Period
Week 6
|
53.99 score on a scale
Standard Deviation 16.42
|
52.12 score on a scale
Standard Deviation 12.25
|
|
Difference in Quality of Life at the End of Treatment/Waitlist Period
Week 12
|
66.45 score on a scale
Standard Deviation 16.45
|
55.20 score on a scale
Standard Deviation 12.40
|
Adverse Events
Smartphone-delivered CBT for BDD
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Waitlist Control
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Smartphone-delivered CBT for BDD
n=40 participants at risk
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.
|
Waitlist Control
n=40 participants at risk
12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for BDD following the 12-week waitlist control).
|
|---|---|---|
|
Psychiatric disorders
Increased anxiety or depression
|
12.5%
5/40 • 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.
|
2.5%
1/40 • 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.
|
|
Psychiatric disorders
Suicidal ideation worsening
|
12.5%
5/40 • 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.
|
2.5%
1/40 • 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.
|
|
Immune system disorders
Allergies, allergic reactions
|
7.5%
3/40 • 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.
|
5.0%
2/40 • 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.
|
|
Injury, poisoning and procedural complications
Injuries and accidents
|
7.5%
3/40 • 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.
|
2.5%
1/40 • 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.
|
|
Injury, poisoning and procedural complications
Procedural complications
|
0.00%
0/40 • 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.
|
5.0%
2/40 • 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.
|
|
Nervous system disorders
Migraine
|
5.0%
2/40 • 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.
|
0.00%
0/40 • 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.
|
|
Reproductive system and breast disorders
Endometriosis
|
5.0%
2/40 • 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.
|
0.00%
0/40 • 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.
|
|
Surgical and medical procedures
Medical procedure
|
5.0%
2/40 • 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.
|
2.5%
1/40 • 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.
|
|
Psychiatric disorders
Other
|
0.00%
0/40 • 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.
|
7.5%
3/40 • 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.
|
Additional Information
Director, Center for OCD and Related Disorders
Massachusetts General Hospital, Department of Psychiatry
Phone: 617-724-6146
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place