Trial Outcomes & Findings for A Unified Treatment for Anxiety Disorders (NCT NCT00586001)
NCT ID: NCT00586001
Last Updated: 2018-12-11
Results Overview
DSM-IV diagnoses of anxiety disorders. Principal and additional diagnoses are assigned a clinical severity rating (CSR) on a scale from 0 (no symptoms) to 8 (extremely severe symptoms), with a rating of 4 or above (definitely disturbing/disabling) passing the clinical threshold for DSM-IV diagnostic criteria.
COMPLETED
NA
37 participants
Measured at pre-treatment (baseline) and post-treatment (month 3)
2018-12-11
Participant Flow
Participant milestones
| Measure |
Unified Treatment
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-List Control
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
11
|
|
Overall Study
COMPLETED
|
22
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Unified Treatment for Anxiety Disorders
Baseline characteristics by cohort
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
29.38 years
n=5 Participants
|
30.64 years
n=7 Participants
|
30.01 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
11 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)DSM-IV diagnoses of anxiety disorders. Principal and additional diagnoses are assigned a clinical severity rating (CSR) on a scale from 0 (no symptoms) to 8 (extremely severe symptoms), with a rating of 4 or above (definitely disturbing/disabling) passing the clinical threshold for DSM-IV diagnostic criteria.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Anxiety Disorders Interview Schedule for DSM-IV
Pre
|
5.23 score on a scale
Standard Deviation 0.89
|
5.09 score on a scale
Standard Deviation 0.79
|
|
Anxiety Disorders Interview Schedule for DSM-IV
Post
|
3.18 score on a scale
Standard Deviation 1.55
|
5.14 score on a scale
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Reported scores are the mean total scores.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Structured Interview Guide for the Hamilton Anxiety Rating Scale
Pre
|
16.15 score on a scale
Standard Deviation 7.91
|
14.36 score on a scale
Standard Deviation 5.19
|
|
Structured Interview Guide for the Hamilton Anxiety Rating Scale
Post
|
7.39 score on a scale
Standard Deviation 5.37
|
13.08 score on a scale
Standard Deviation 4.22
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)Structured Interview Guide for the Hamilton Depression Rating Scale, items are scored on scale of 0 to 4, higher score meaning a higher severity. Total scores can range from 0 (no symptoms) to 53 (severe). Reported scores are a mean of the total scores.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Structured Interview Guide for the Hamilton Depression Rating Scale
Pre
|
10.35 score on a scale
Standard Deviation 5.77
|
10.09 score on a scale
Standard Deviation 3.87
|
|
Structured Interview Guide for the Hamilton Depression Rating Scale
Post
|
5.49 score on a scale
Standard Deviation 4.63
|
7.85 score on a scale
Standard Deviation 4.01
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)Positive and Negative Affect Schedule-Negative Affectivity; Positive and Negative Affect Schedule-Positive Affectivity; Items are rated on a scale of 1 (very slightly or not at all) to 5 (extremely) relating to how a person feels average feels the indicated emotion. Total scores can range from 20 to 100. Higher scores are more severe. Reported scores are based on mean totals.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Positive and Negative Affect Scale
Pre; Positive Affect
|
28.81 score on a scale
Standard Deviation 6.27
|
28.00 score on a scale
Standard Deviation 7.19
|
|
Positive and Negative Affect Scale
Post; Positive Affect
|
32.84 score on a scale
Standard Deviation 6.50
|
27.17 score on a scale
Standard Deviation 8.61
|
|
Positive and Negative Affect Scale
Pre; Negative Affect
|
26.62 score on a scale
Standard Deviation 5.48
|
24.36 score on a scale
Standard Deviation 5.21
|
|
Positive and Negative Affect Scale
Post; Negative Affect
|
20.57 score on a scale
Standard Deviation 4.95
|
22.86 score on a scale
Standard Deviation 7.03
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)Items are measured on a scale from 0 (little to no symptoms) to 3 (severe). Total scores can range from 0 to 63, higher ratings are more severe. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. The reported scores are mean total scores.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Beck Depression Inventory - II
Pre
|
11.96 score on a scale
Standard Deviation 7.53
|
11.73 score on a scale
Standard Deviation 9.92
|
|
Beck Depression Inventory - II
Post
|
4.21 score on a scale
Standard Deviation 4.43
|
11.45 score on a scale
Standard Deviation 9.64
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)Items are scored on a 0 to 3 scale. Total scores range from 0 to 63. 0-9 is minimal, 10-16 is mild, 17-29 is moderate, and 30-63 is severe. Reported scores are a mean of total scores.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Beck Anxiety Inventory
Pre
|
19.08 score on a scale
Standard Deviation 9.93
|
16.91 score on a scale
Standard Deviation 6.97
|
|
Beck Anxiety Inventory
Post
|
8.27 score on a scale
Standard Deviation 6.51
|
12.22 score on a scale
Standard Deviation 7.93
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)Items are scored on a 0 to 8 scale. The total score range is 0 to 40. Higher scores are more severe. Reported scores are means of total scores.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Work and Social Adjustment Scale
Pre
|
16.04 score on a scale
Standard Deviation 6.53
|
16.46 score on a scale
Standard Deviation 2.39
|
|
Work and Social Adjustment Scale
Post
|
7.62 score on a scale
Standard Deviation 5.40
|
13.14 score on a scale
Standard Deviation 3.66
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)Items are rated on a scale of 0 to 4. Scores can range from 0 to 28. Higher scores indicate higher severity of Panic Disorder symptoms
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Panic Disorder Severity Scale - Self Report Version
Pre
|
7.65 score on a scale
Standard Deviation 5.68
|
7.09 score on a scale
Standard Deviation 7.04
|
|
Panic Disorder Severity Scale - Self Report Version
Post
|
2.77 score on a scale
Standard Deviation 3.01
|
6.20 score on a scale
Standard Deviation 7.02
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)The PSWQ is a 16-item questionnaire. Items are rated from 1 to 5, and a total score can range from 16 to 80. Higher scores indicate higher severity of worry symptoms.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Penn State Worry Questionnaire
Pre
|
62.27 score on a scale
Standard Deviation 11.54
|
62.55 score on a scale
Standard Deviation 10.76
|
|
Penn State Worry Questionnaire
Post
|
49.18 score on a scale
Standard Deviation 13.89
|
60.30 score on a scale
Standard Deviation 15.86
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)The SIAS is a twenty-item measure. Experiences are rated on a 5-point scale from 0 to 4. Experiences are rated on a global period of what is typical. A total score of 60 is possible with cutoffs of 34+ indicative of social phobia and 43+ indicative of social anxiety.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Social Interaction Anxiety Scale
Pre
|
28.19 score on a scale
Standard Deviation 17.99
|
38.18 score on a scale
Standard Deviation 20.03
|
|
Social Interaction Anxiety Scale
Post
|
23.32 score on a scale
Standard Deviation 16.76
|
37.60 score on a scale
Standard Deviation 20.56
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)The QOLI is a 32 item self-report, asking about the importance of 16 domains of life and a participant's satisfaction in each domain. Scores can range from -48 to 115. Higher scores indicate higher quality of life.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Quality of Life Inventory
Pre-Treatment
|
35.46 score on a scale
Standard Deviation 19.52
|
32.45 score on a scale
Standard Deviation 10.40
|
|
Quality of Life Inventory
Post-Treatment
|
46.73 score on a scale
Standard Deviation 14.00
|
34.67 score on a scale
Standard Deviation 11.15
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)The Y-BOCS is a 12-item scale used to see symptom severity of obsessions and compulsions. Items are scored from 0 to 4. The total score can range from 0 to 48. A higher score indicates higher symptom severity.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Yale-Brown Obsessive Compulsive Scale
Pre
|
8.81 score on a scale
Standard Deviation 9.47
|
7.18 score on a scale
Standard Deviation 9.91
|
|
Yale-Brown Obsessive Compulsive Scale
Post
|
6.09 score on a scale
Standard Deviation 8.17
|
8.65 score on a scale
Standard Deviation 8.76
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)The ERQ-2 is a 16 item self-report. Items are scored from 1 to 7, and focus on emotional experience and emotional expression. Scores can range from 16 to 112, and higher scores indicate stronger cognitive reappraisal and expressive suppression abilities.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Emotion Regulation Questionnaire - 2
Pre-Treatment
|
55.40 score on a scale
Standard Deviation 16.82
|
60.36 score on a scale
Standard Deviation 22.01
|
|
Emotion Regulation Questionnaire - 2
Post-Treatment
|
59.95 score on a scale
Standard Deviation 15.74
|
60.00 score on a scale
Standard Deviation 18.68
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)The Behavioral Inhibition System/Behavioral Approach System Scales is a 20-item self-report where all items can be rated from 0 to 3. The total score can range from 0 to 60. Higher scores indicate higher levels of behavioral inhibition skills.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
BIS/BAS Scales (Carver & White, 1994)
Pre-Treatment BIS
|
24.15 score on a scale
Standard Deviation 3.41
|
24.45 score on a scale
Standard Deviation 2.16
|
|
BIS/BAS Scales (Carver & White, 1994)
Post-Treatment BIS
|
22.32 score on a scale
Standard Deviation 4.14
|
23.60 score on a scale
Standard Deviation 2.79
|
|
BIS/BAS Scales (Carver & White, 1994)
Pre-Treatment BAS
|
38.09 score on a scale
Standard Deviation 6.55
|
35.18 score on a scale
Standard Deviation 7.18
|
|
BIS/BAS Scales (Carver & White, 1994)
Post-Treatment BAS
|
40.27 score on a scale
Standard Deviation 5.78
|
35.40 score on a scale
Standard Deviation 8.13
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)The ACS is a 42 item scale where each item is rated from 1 to 7. Scores can range from 42 to 294. Higher scores indicate higher skill levels for controlling emotions
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Affective Control Scale
Pre-Treatment
|
140.92 score on a scale
Standard Deviation 26.48
|
141.00 score on a scale
Standard Deviation 35.08
|
|
Affective Control Scale
Post-Treatment
|
106.36 score on a scale
Standard Deviation 25.34
|
141.60 score on a scale
Standard Deviation 40.63
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)The ASI is a 16 item self report where items can be scored from 0 to 4. Scores can range from 0 to 64. Higher scores indicate a higher sensitivity to anxiety and it's symptoms.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Anxiety Sensitivity Index
Post-Treatment
|
19.36 score on a scale
Standard Deviation 12.75
|
25.50 score on a scale
Standard Deviation 12.40
|
|
Anxiety Sensitivity Index
Pre-Treatment
|
29.62 score on a scale
Standard Deviation 11.56
|
29.27 score on a scale
Standard Deviation 10.53
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)The TAF is a 19 item self report where each item can be scored from 0 to 4. Scores can range from 0 to 76. Higher scores indicate a higher frequency of maladaptive cognitive intrusions.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
The Thought-Action Fusion Scale (Shafran et al., 1996)
Pre-Treatment
|
13.46 score on a scale
Standard Deviation 14.03
|
16.82 score on a scale
Standard Deviation 15.82
|
|
The Thought-Action Fusion Scale (Shafran et al., 1996)
Post-Treatment
|
11.43 score on a scale
Standard Deviation 9.67
|
16.90 score on a scale
Standard Deviation 17.51
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)The IUS is a 27-item self report where each item can be scored from 0 to 4. Scores range from 0 to 108. It rates response to uncertainty, ambiguous situations, and the future. Higher scores indicate higher anxiety and depressive symptoms.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
Intolerance of Uncertainty Scale (IUS)
Pre-Treatment
|
40.38 score on a scale
Standard Deviation 20.14
|
39.27 score on a scale
Standard Deviation 21.86
|
|
Intolerance of Uncertainty Scale (IUS)
Post-Treatment
|
27.77 score on a scale
Standard Deviation 19.57
|
40.25 score on a scale
Standard Deviation 28.38
|
SECONDARY outcome
Timeframe: Measured at pre-treatment (baseline) and post-treatment (month 3)The TMMS is a 48 item self report where each item can be scored from 1 to 5. The three subscales are Attention, Clarity, and Repair. Scores for each of the three subscales can each range from 16 to 80. Higher scores indicate higher emotion regulation skills.
Outcome measures
| Measure |
Unified Treatment
n=26 Participants
Unified treatment: The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders.
|
Wait-list Control
n=11 Participants
Wait-list control: Participants were asked to wait 16 weeks before receiving treatment.
|
|---|---|---|
|
The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995)
Pre-Treatment Repair Subscale
|
39.43 score on a scale
Standard Deviation 4.40
|
37.40 score on a scale
Standard Deviation 4.09
|
|
The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995)
Post-Treatment Attention Subscale
|
80.68 score on a scale
Standard Deviation 8.12
|
76.00 score on a scale
Standard Deviation 11.63
|
|
The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995)
Pre-Treatment Attention Subscale
|
76.83 score on a scale
Standard Deviation 8.84
|
76.50 score on a scale
Standard Deviation 9.40
|
|
The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995)
Pre-Treatment Clarity Subscale
|
50.83 score on a scale
Standard Deviation 7.65
|
51.30 score on a scale
Standard Deviation 11.74
|
|
The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995)
Post-Treatment Clarity Subscale
|
54.69 score on a scale
Standard Deviation 7.91
|
54.31 score on a scale
Standard Deviation 11.37
|
|
The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995)
Post-Treatment Repair Subscale
|
40.59 score on a scale
Standard Deviation 4.42
|
37.89 score on a scale
Standard Deviation 5.53
|
Adverse Events
Unified Treatment
Wait-list Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Todd Farchione
Boston University Charles River Campus
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place