Trial Outcomes & Findings for Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder (NCT NCT01453439)
NCT ID: NCT01453439
Last Updated: 2020-07-15
Results Overview
The Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS) is a 12-item, semi-structured, clinician-administered measure of BDD symptom severity. The scale's items are summed to yield a total score with a range from 0 to 48, with higher scores indicating more severe BDD symptoms. Treatment effects on BDD symptom severity were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 24), assessed every 4 weeks. Followup phase data was measured at week 37 and week 50.
Results posted on
2020-07-15
Participant Flow
Participant milestones
| Measure |
Cognitive Behavior Therapy (CBT)
Cognitive Behavior Therapy (CBT) is considered the psychosocial treatment of choice for BDD. It is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD. CBT is the only fully developed psychosocial treatment for BDD.
|
Supportive Psychotherapy (SPT)
SPT is a widely received psychosocial treatment by persons with BDD.
|
|---|---|---|
|
Treatment Phase
STARTED
|
61
|
59
|
|
Treatment Phase
COMPLETED
|
44
|
48
|
|
Treatment Phase
NOT COMPLETED
|
17
|
11
|
|
Follow-up
STARTED
|
44
|
48
|
|
Follow-up
COMPLETED
|
39
|
37
|
|
Follow-up
NOT COMPLETED
|
5
|
11
|
Reasons for withdrawal
| Measure |
Cognitive Behavior Therapy (CBT)
Cognitive Behavior Therapy (CBT) is considered the psychosocial treatment of choice for BDD. It is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD. CBT is the only fully developed psychosocial treatment for BDD.
|
Supportive Psychotherapy (SPT)
SPT is a widely received psychosocial treatment by persons with BDD.
|
|---|---|---|
|
Treatment Phase
Withdrawal by Subject
|
13
|
10
|
|
Treatment Phase
Suicidal Ideation
|
2
|
0
|
|
Treatment Phase
Need for higher level of care
|
1
|
1
|
|
Treatment Phase
Therapist conflict of interest
|
1
|
0
|
|
Follow-up
Withdrawal by Subject
|
0
|
1
|
|
Follow-up
Lost to Follow-up
|
5
|
10
|
Baseline Characteristics
Cognitive-Behavioral Therapy and Supportive Psychotherapy for Body Dysmorphic Disorder
Baseline characteristics by cohort
| Measure |
Cognitive Behavior Therapy (CBT)
n=61 Participants
Cognitive Behavior Therapy (CBT) is considered the psychosocial treatment of choice for BDD. It is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD. CBT is the only fully developed psychosocial treatment for BDD.
|
Supportive Psychotherapy (SPT)
n=59 Participants
SPT is a widely received psychosocial treatment by persons with BDD.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 14.5 • n=5 Participants
|
33.4 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
33.9 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic
|
47 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Hispanic
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change in BDD-YBOCS from baseline (week 0) to post-treatment (week 24), assessed every 4 weeks. Followup phase data was measured at week 37 and week 50.Population: Intent to treat analysis on 120 subjects randomized to either CBT vs SPT. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below.
The Yale-Brown Obsessive Compulsive Scale Modified for BDD (BDD-YBOCS) is a 12-item, semi-structured, clinician-administered measure of BDD symptom severity. The scale's items are summed to yield a total score with a range from 0 to 48, with higher scores indicating more severe BDD symptoms. Treatment effects on BDD symptom severity were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Outcome measures
| Measure |
Cognitive Behavior Therapy (CBT)
n=61 Participants
Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.
|
Supportive Psychotherapy (SPT)
n=59 Participants
SPT is the most common psychosocial treatment received by persons with BDD.
|
|---|---|---|
|
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
Week 12
|
19.67 score on a scale
Standard Deviation 8.21
|
22.80 score on a scale
Standard Deviation 8.90
|
|
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
week 16
|
17.74 score on a scale
Standard Deviation 9.21
|
22.13 score on a scale
Standard Deviation 9.33
|
|
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
Week 20
|
15.95 score on a scale
Standard Deviation 9.32
|
19.02 score on a scale
Standard Deviation 9.44
|
|
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
Week 24
|
13.34 score on a scale
Standard Deviation 9.46
|
18.67 score on a scale
Standard Deviation 9.77
|
|
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
Week 37
|
12.30 score on a scale
Standard Deviation 9.84
|
17.46 score on a scale
Standard Deviation 9.81
|
|
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
Week 50
|
12.31 score on a scale
Standard Deviation 10.75
|
16.90 score on a scale
Standard Deviation 10.94
|
|
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
Baseline
|
32.21 score on a scale
Standard Deviation 4.72
|
31.49 score on a scale
Standard Deviation 4.94
|
|
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
Week 4
|
26.92 score on a scale
Standard Deviation 6.20
|
27.27 score on a scale
Standard Deviation 6.41
|
|
Body Dysmorphic Disorder Symptoms (as Measured by the BDD-YBOCS)
Week 8
|
24.34 score on a scale
Standard Deviation 7.70
|
25.09 score on a scale
Standard Deviation 7.57
|
SECONDARY outcome
Timeframe: Measured every 4 weeks during treatment, and at the 3-(wk 37) and 6-month(wk 50) follow-up visitsPopulation: Intent to treat analysis on 120 subjects randomized to either CBT vs SPT. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below.
The Brown Assessment of Beliefs Scale (BABS) is a 7-item, semi-structured, clinician-administered measure that was used to assess insight regarding BDD-related beliefs (e.g., "I look deformed"). The first six items of the BABS were summed to obtain a total score ranging from 0 to 24, with higher scores reflecting poorer insight. Treatment effects on BABS score were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Outcome measures
| Measure |
Cognitive Behavior Therapy (CBT)
n=61 Participants
Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.
|
Supportive Psychotherapy (SPT)
n=59 Participants
SPT is the most common psychosocial treatment received by persons with BDD.
|
|---|---|---|
|
Insight Regarding BDD Beliefs (as Measured by the BABS)
Baseline
|
17.2459016 units on a scale
Standard Deviation 4.2608909
|
15.4067797 units on a scale
Standard Deviation 4.1817281
|
|
Insight Regarding BDD Beliefs (as Measured by the BABS)
Week 4
|
14.7500000 units on a scale
Standard Deviation 5.2538501
|
13.3090909 units on a scale
Standard Deviation 5.0584463
|
|
Insight Regarding BDD Beliefs (as Measured by the BABS)
Week 8
|
14.5128205 units on a scale
Standard Deviation 5.9066056
|
12.8500000 units on a scale
Standard Deviation 5.0765928
|
|
Insight Regarding BDD Beliefs (as Measured by the BABS)
Week 12
|
10.8837209 units on a scale
Standard Deviation 5.8562515
|
11.1304348 units on a scale
Standard Deviation 6.0428422
|
|
Insight Regarding BDD Beliefs (as Measured by the BABS)
week 16
|
10.8571429 units on a scale
Standard Deviation 7.2769983
|
9.7608696 units on a scale
Standard Deviation 5.3465868
|
|
Insight Regarding BDD Beliefs (as Measured by the BABS)
Week 20
|
9.8461538 units on a scale
Standard Deviation 6.5435322
|
10.0277778 units on a scale
Standard Deviation 5.8235292
|
|
Insight Regarding BDD Beliefs (as Measured by the BABS)
Week 24
|
8.3636364 units on a scale
Standard Deviation 7.5823875
|
7.9791667 units on a scale
Standard Deviation 5.8908136
|
|
Insight Regarding BDD Beliefs (as Measured by the BABS)
Week 37
|
6.6279070 units on a scale
Standard Deviation 7.0000791
|
8.3170732 units on a scale
Standard Deviation 5.8199614
|
|
Insight Regarding BDD Beliefs (as Measured by the BABS)
Week 50
|
7.1578947 units on a scale
Standard Deviation 7.9679300
|
7.3783784 units on a scale
Standard Deviation 5.7848046
|
SECONDARY outcome
Timeframe: Measured every week during treatment, but analysis was performed only on BDI-II assessments close to assessment visits; wk 0, 4, 8, 12, 16, 20 and 24. Followup phase data was measured at week 37 and week 50.Population: Intent to treat analysis on 120 subjects randomized to either CBT vs SPT. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below.
The Beck Depression Inventory-Second Edition (BDI-II) is a widely used 21-item self-report scale that assesses the severity of depressive symptoms during the past 2 weeks. Total scale scores range from 0 to 63, with higher scores indicating greater symptom severity. Treatment effects on depression were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Outcome measures
| Measure |
Cognitive Behavior Therapy (CBT)
n=61 Participants
Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.
|
Supportive Psychotherapy (SPT)
n=59 Participants
SPT is the most common psychosocial treatment received by persons with BDD.
|
|---|---|---|
|
Depressive Symptoms (as Measured by the BDI-II)
Baseline
|
22.1639344 units on a scale
Standard Deviation 13.1923972
|
22.8620690 units on a scale
Standard Deviation 13.6117187
|
|
Depressive Symptoms (as Measured by the BDI-II)
Week 4
|
18.6923077 units on a scale
Standard Deviation 11.7215044
|
21.4035088 units on a scale
Standard Deviation 14.9938793
|
|
Depressive Symptoms (as Measured by the BDI-II)
Week 8
|
16.9591837 units on a scale
Standard Deviation 13.4953066
|
19.3076923 units on a scale
Standard Deviation 14.3178737
|
|
Depressive Symptoms (as Measured by the BDI-II)
week 16
|
13.4000000 units on a scale
Standard Deviation 12.9446374
|
17.5416667 units on a scale
Standard Deviation 15.3220163
|
|
Depressive Symptoms (as Measured by the BDI-II)
Week 12
|
15.2000000 units on a scale
Standard Deviation 13.1037815
|
19.6041667 units on a scale
Standard Deviation 14.8563900
|
|
Depressive Symptoms (as Measured by the BDI-II)
Week 20
|
11.4545455 units on a scale
Standard Deviation 11.3474811
|
15.9302326 units on a scale
Standard Deviation 14.2300744
|
|
Depressive Symptoms (as Measured by the BDI-II)
Week 24
|
10.5348837 units on a scale
Standard Deviation 12.2966291
|
15.6041667 units on a scale
Standard Deviation 14.2541365
|
|
Depressive Symptoms (as Measured by the BDI-II)
Week 37
|
9.2307692 units on a scale
Standard Deviation 11.4120470
|
12.8611111 units on a scale
Standard Deviation 13.9328036
|
|
Depressive Symptoms (as Measured by the BDI-II)
Week 50
|
12.0606061 units on a scale
Standard Deviation 15.3030622
|
13.6666667 units on a scale
Standard Deviation 13.6541855
|
SECONDARY outcome
Timeframe: Measured at week 0, 4, 12, 16, and 24 during treatment. Follow-up phase data was measured at week 37 and at week 50.Population: Intent to treat analysis on 120 subjects randomized to either CBT vs SPT. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below.
The Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LESQ-SF) is a 16-item, self-report questionnaire that assesses life satisfaction over the past week. Questions 1-14 are then summed to a total score, and the total score is reported as a percentage maximum possible, such that the % score range is 0% to 100%, with higher scores indicating greater quality of life. Treatment effects on life satisfaction were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Outcome measures
| Measure |
Cognitive Behavior Therapy (CBT)
n=61 Participants
Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.
|
Supportive Psychotherapy (SPT)
n=59 Participants
SPT is the most common psychosocial treatment received by persons with BDD.
|
|---|---|---|
|
Life Satisfaction (Q-LESQ-SF)
Baseline
|
48.7500000 units on a scale
Standard Deviation 15.0603393
|
50.6961259 units on a scale
Standard Deviation 16.6428814
|
|
Life Satisfaction (Q-LESQ-SF)
Week 4
|
49.6648352 units on a scale
Standard Deviation 15.8763522
|
51.7857143 units on a scale
Standard Deviation 18.0729259
|
|
Life Satisfaction (Q-LESQ-SF)
Week 12
|
61.0119048 units on a scale
Standard Deviation 17.3217504
|
57.6190476 units on a scale
Standard Deviation 17.6382690
|
|
Life Satisfaction (Q-LESQ-SF)
Week 16
|
60.8894231 units on a scale
Standard Deviation 15.9117634
|
57.3457792 units on a scale
Standard Deviation 19.9192124
|
|
Life Satisfaction (Q-LESQ-SF)
week 24
|
68.2055749 units on a scale
Standard Deviation 19.3905036
|
63.9437690 units on a scale
Standard Deviation 19.0175684
|
|
Life Satisfaction (Q-LESQ-SF)
Week 37
|
69.1849817 units on a scale
Standard Deviation 17.5141781
|
64.3339768 units on a scale
Standard Deviation 17.0683239
|
|
Life Satisfaction (Q-LESQ-SF)
Week 50
|
66.5095899 units on a scale
Standard Deviation 21.2768017
|
65.8928571 units on a scale
Standard Deviation 19.3884669
|
SECONDARY outcome
Timeframe: Measured twice during the study (week 0 [pre-treatment] and at week 4)Population: The analysis population for this analysis was limited to those participants who completed the questionnaire (n=6 missing responses in the CBT arm, n=5 missing responses in the SPT arm at baseline), and decrease by week 4 due to study drop-out or missed assessments.
The Treatment Credibility/Expectancy Rating scale is a 4-item self-report questionnaire that assesses patients' judgments about the credibility of the treatment rationale, expectancy of change, and treatment acceptability. Treatment credibility is based on the mean score of the first three items, which are measured on 10-point Likert scales, so that mean scores range from 1 (lowest/worst) to 10 (highest/most). Treatment credibility was assessed at the baseline assessment (before treatment assignment) and after 1 month of treatment when patients are more familiar with the treatment protocol and rationale.
Outcome measures
| Measure |
Cognitive Behavior Therapy (CBT)
n=55 Participants
Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.
|
Supportive Psychotherapy (SPT)
n=54 Participants
SPT is the most common psychosocial treatment received by persons with BDD.
|
|---|---|---|
|
Treatment Credibility (Credibility/Expectancy Rating Scale)
Week 0
|
7.10 score on a scale
Standard Deviation 1.79
|
6.64 score on a scale
Standard Deviation 1.84
|
|
Treatment Credibility (Credibility/Expectancy Rating Scale)
Week 4
|
7.19 score on a scale
Standard Deviation 1.68
|
6.28 score on a scale
Standard Deviation 1.84
|
SECONDARY outcome
Timeframe: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured three times during the study (week 0 [pre-treatment], week 12, and week 24 [post-treatment])Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured at baseline, week 4, week 12, week 16, and week 24. Follow-up phase data was measured at week 37 and at week 50.Population: Intent to treat analysis on 120 subjects randomized to either CBT vs SPT. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below.
The Sheehan Disability Scale (SDS) is a 5-item self-report measure of functional impairment/disability. Items 1-3 (disability in work, social life/leisure, and family life/home responsibilities, respectively) are scored on Likert-scales that range from 0 (not at all) to 10 (extreme). The three items are then summed to yield an SDS total score, ranging from 0 (unimpaired) to 30 (highly impaired). Treatment effects on functional impairment were analyzed separately for the treatment period (i.e., weeks 0-24) and the follow-up period (i.e., weeks 24 to 50).
Outcome measures
| Measure |
Cognitive Behavior Therapy (CBT)
n=61 Participants
Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.
|
Supportive Psychotherapy (SPT)
n=59 Participants
SPT is the most common psychosocial treatment received by persons with BDD.
|
|---|---|---|
|
Sheehan Disability Scale (SDS)
Week 4
|
15.1000000 score on a scale
Standard Deviation 6.3927574
|
15.5000000 score on a scale
Standard Deviation 7.0056000
|
|
Sheehan Disability Scale (SDS)
Week 12
|
11.7142857 score on a scale
Standard Deviation 7.4023257
|
12.2222222 score on a scale
Standard Deviation 7.8534558
|
|
Sheehan Disability Scale (SDS)
Week 16
|
9.7250000 score on a scale
Standard Deviation 7.6660674
|
11.7272727 score on a scale
Standard Deviation 8.2019953
|
|
Sheehan Disability Scale (SDS)
week 24
|
7.9024390 score on a scale
Standard Deviation 8.2970021
|
9.0869565 score on a scale
Standard Deviation 7.2105666
|
|
Sheehan Disability Scale (SDS)
Week 37
|
6.4871795 score on a scale
Standard Deviation 6.3613628
|
9.2162162 score on a scale
Standard Deviation 7.7428646
|
|
Sheehan Disability Scale (SDS)
Week 50
|
6.6388889 score on a scale
Standard Deviation 8.1980931
|
8.3666667 score on a scale
Standard Deviation 7.8013409
|
|
Sheehan Disability Scale (SDS)
Baseline
|
16.3333333 score on a scale
Standard Deviation 5.5621806
|
17.4406780 score on a scale
Standard Deviation 6.0522757
|
SECONDARY outcome
Timeframe: The CSQ-8 was assessed twice: at week 12 [mid-treatment] and at week 24 [post-treatment]Population: The analysis population for this outcome was limited to those who were still in the study by week 12 (mid-treatmtent) and who completed the questionnaire.
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report questionnaire that assesses satisfaction with clinical services received and has a score range of 8-32, where higher scores indicate higher satisfaction.
Outcome measures
| Measure |
Cognitive Behavior Therapy (CBT)
n=47 Participants
Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.
|
Supportive Psychotherapy (SPT)
n=52 Participants
SPT is the most common psychosocial treatment received by persons with BDD.
|
|---|---|---|
|
Treatment Satisfaction (CSQ-8)
Week 12
|
28.02 score on a scale
Standard Deviation 2.88
|
26.60 score on a scale
Standard Deviation 3.82
|
|
Treatment Satisfaction (CSQ-8)
Week 24
|
29.40 score on a scale
Standard Deviation 3.56
|
27.56 score on a scale
Standard Deviation 4.07
|
SECONDARY outcome
Timeframe: Measured twice during the study (week 0 [pre-treatment] and at week 4)Population: The analysis population for this analysis was limited to those participants who completed the questionnaire (n=6 missing responses in the CBT arm, n=5 missing responses in the SPT arm at baseline), and decrease by week 4 due to study drop-out or missed assessments.
The Treatment Credibility/Expectancy Rating scale is a 4-item self-report questionnaire that assesses patients' judgments about the credibility of the treatment rationale, expectancy of change, and treatment acceptability. Treatment expectancy is a single item rating of "By the end of therapy, how much improvement in your anxiety do you think will occur?", rated on a scale from 0% to 100%. It was assessed at the baseline assessment (before treatment assignment) and after 1 month of treatment when patients are more familiar with the treatment protocol and rationale.
Outcome measures
| Measure |
Cognitive Behavior Therapy (CBT)
n=55 Participants
Cognitive-behavioral therapy (CBT) is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD.
|
Supportive Psychotherapy (SPT)
n=54 Participants
SPT is the most common psychosocial treatment received by persons with BDD.
|
|---|---|---|
|
Treatment Expectancy (Credibility/Expectancy Rating Scale)
Week 4
|
56.00 Percent improvement expected (0-100%)
Standard Deviation 20.40
|
46.73 Percent improvement expected (0-100%)
Standard Deviation 20.55
|
|
Treatment Expectancy (Credibility/Expectancy Rating Scale)
Week 0
|
58.36 Percent improvement expected (0-100%)
Standard Deviation 20.71
|
50.19 Percent improvement expected (0-100%)
Standard Deviation 19.28
|
Adverse Events
Cognitive Behavior Therapy (CBT)
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
Supportive Psychotherapy (SPT)
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cognitive Behavior Therapy (CBT)
n=61 participants at risk
Cognitive Behavior Therapy (CBT) is considered the psychosocial treatment of choice for BDD. It is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD. CBT is the only fully developed psychosocial treatment for BDD.
|
Supportive Psychotherapy (SPT)
n=59 participants at risk
SPT is a widely received psychosocial treatment by persons with BDD.
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
1.6%
1/61 • Number of events 1 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
1.7%
1/59 • Number of events 1 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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
Increase in BDD and depressive Symptoms
|
1.6%
1/61 • Number of events 2 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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%
0/59 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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
Self-harm
|
1.6%
1/61 • Number of events 1 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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%
0/59 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
|
Gastrointestinal disorders
Negative reaction to anesthesia
|
1.6%
1/61 • Number of events 1 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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%
0/59 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
|
General disorders
Pain felt in one arm for a couple of days
|
1.6%
1/61 • Number of events 1 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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%
0/59 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
|
Infections and infestations
Mononucleosis
|
0.00%
0/61 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
1.7%
1/59 • Number of events 1 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
|
Cardiac disorders
Cardiac surgery
|
1.6%
1/61 • Number of events 1 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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%
0/59 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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
Anaphylactic shock
|
0.00%
0/61 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
1.7%
1/59 • Number of events 1 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
Other adverse events
| Measure |
Cognitive Behavior Therapy (CBT)
n=61 participants at risk
Cognitive Behavior Therapy (CBT) is considered the psychosocial treatment of choice for BDD. It is a time-limited treatment that includes cognitive restructuring, mindfulness/attention retraining, exposure, and response prevention, specifically tailored for BDD. CBT is the only fully developed psychosocial treatment for BDD.
|
Supportive Psychotherapy (SPT)
n=59 participants at risk
SPT is a widely received psychosocial treatment by persons with BDD.
|
|---|---|---|
|
Psychiatric disorders
Increased anxiety and/or depression
|
13.1%
8/61 • Number of events 12 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
22.0%
13/59 • Number of events 14 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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
Increase in other psychiatric symptoms
|
13.1%
8/61 • Number of events 8 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
5.1%
3/59 • Number of events 3 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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 and/or self-harm
|
6.6%
4/61 • Number of events 6 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
1.7%
1/59 • Number of events 1 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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
Injury, poisoning, and procedural complications
|
14.8%
9/61 • Number of events 16 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
8.5%
5/59 • Number of events 6 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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
Nervous system disorders
|
6.6%
4/61 • Number of events 4 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
5.1%
3/59 • Number of events 3 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
3.3%
2/61 • Number of events 2 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
5.1%
3/59 • Number of events 3 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
|
Social circumstances
Social circumstances
|
3.3%
2/61 • Number of events 2 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
5.1%
3/59 • Number of events 3 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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
Surgical and medical procedures
|
3.3%
2/61 • Number of events 2 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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.
|
6.8%
4/59 • Number of events 4 • Adverse event data was collected every 4 weeks at the beginning of therapy sessions, at the post-treatment visit, and at the 3- and 6-month follow-up visits (for a total of 1 year for each participant who completed the full study protocol). At these assessments, participants were probed for adverse events that occurred since the last adverse event assessment (usually 4 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
Dr. Sabine Wilhelm, Ph.D.
Massachusetts General Hospital
Phone: +1(617)724-6146
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place