Trial Outcomes & Findings for Reward Processes and Rehearsal in Exposure Therapy (NCT NCT06132425)
NCT ID: NCT06132425
Last Updated: 2025-06-13
Results Overview
Responses to two self-reported questions assessing public speaking anxiety and avoidance (scored from 0-8, where higher scores reflect greater public speaking anxiety and avoidance) and responses to the Personal Report of Public Speaking Anxiety (PRPSA; scored from 34-170, where higher scores reflect greater public speaking anxiety symptom severity).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
88 participants
Primary outcome timeframe
Baseline through study completion, an average of 3 weeks.
Results posted on
2025-06-13
Participant Flow
Participant milestones
| Measure |
Positive Rehearsal
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to identify positive emotional experiences associated with exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
Neutral Rehearsal
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to maintain a neutral, non-emotional stance and focus on overall exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
44
|
|
Overall Study
Visit 1
|
42
|
42
|
|
Overall Study
Visit 2
|
38
|
40
|
|
Overall Study
Follow-Up
|
38
|
37
|
|
Overall Study
COMPLETED
|
38
|
37
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Positive Rehearsal
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to identify positive emotional experiences associated with exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
Neutral Rehearsal
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to maintain a neutral, non-emotional stance and focus on overall exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Did not follow study instructions
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
Baseline Characteristics
Reward Processes and Rehearsal in Exposure Therapy
Baseline characteristics by cohort
| Measure |
Positive Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to identify positive emotional experiences associated with exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
Neutral Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to maintain a neutral, non-emotional stance and focus on overall exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.5 years
STANDARD_DEVIATION 4.0 • n=93 Participants
|
20.0 years
STANDARD_DEVIATION 2.5 • n=4 Participants
|
20.2 years
STANDARD_DEVIATION 3.3 • n=27 Participants
|
|
Sex/Gender, Customized
Sex assigned at birth, female
|
35 participants
n=93 Participants
|
39 participants
n=4 Participants
|
74 participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
43 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
PHQ-8
|
8.8 units on a scale
STANDARD_DEVIATION 5.7 • n=93 Participants
|
9.2 units on a scale
STANDARD_DEVIATION 5.3 • n=4 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 5.5 • n=27 Participants
|
|
LSAS
|
72.4 units on a scale
STANDARD_DEVIATION 22.3 • n=93 Participants
|
73.3 units on a scale
STANDARD_DEVIATION 22.9 • n=4 Participants
|
72.9 units on a scale
STANDARD_DEVIATION 22.5 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline through study completion, an average of 3 weeks.Population: 42 participants from each group completed baseline measures. 38 participants in the positive group and 40 in the neutral group completed post-exposure measures (6 lost to follow-up, withdrew from the study, or did not follow study instructions). 38 participants in the positive group and 37 in the neutral group completed follow-up measures (3 lost to follow-up). Additionally, 2 participants in the positive group partially completed follow-up measures.
Responses to two self-reported questions assessing public speaking anxiety and avoidance (scored from 0-8, where higher scores reflect greater public speaking anxiety and avoidance) and responses to the Personal Report of Public Speaking Anxiety (PRPSA; scored from 34-170, where higher scores reflect greater public speaking anxiety symptom severity).
Outcome measures
| Measure |
Positive Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to identify positive emotional experiences associated with exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
Neutral Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to maintain a neutral, non-emotional stance and focus on overall exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
|---|---|---|
|
Change in Public Speaking Anxiety
Baseline public speaking anxiety
|
6.5 units on a scale
Standard Deviation 0.8
|
6.6 units on a scale
Standard Deviation 1.0
|
|
Change in Public Speaking Anxiety
Baseline public speaking avoidance
|
6.2 units on a scale
Standard Deviation 1.4
|
6.3 units on a scale
Standard Deviation 1.2
|
|
Change in Public Speaking Anxiety
Baseline PRPSA
|
136.1 units on a scale
Standard Deviation 14.9
|
138.8 units on a scale
Standard Deviation 14.1
|
|
Change in Public Speaking Anxiety
Post-exposure public speaking anxiety
|
5.4 units on a scale
Standard Deviation 1.5
|
5.3 units on a scale
Standard Deviation 1.7
|
|
Change in Public Speaking Anxiety
Post-exposure public speaking avoidance
|
4.8 units on a scale
Standard Deviation 1.7
|
4.3 units on a scale
Standard Deviation 2.0
|
|
Change in Public Speaking Anxiety
Post-exposure PRPSA
|
123.8 units on a scale
Standard Deviation 17.9
|
122.8 units on a scale
Standard Deviation 19.5
|
|
Change in Public Speaking Anxiety
Follow-up public speaking anxiety
|
5.3 units on a scale
Standard Deviation 1.8
|
4.8 units on a scale
Standard Deviation 1.9
|
|
Change in Public Speaking Anxiety
Follow-up public speaking avoidance
|
4.6 units on a scale
Standard Deviation 1.9
|
4.2 units on a scale
Standard Deviation 2.2
|
|
Change in Public Speaking Anxiety
Follow-up PRPSA
|
122.4 units on a scale
Standard Deviation 19.3
|
119.7 units on a scale
Standard Deviation 18.4
|
SECONDARY outcome
Timeframe: Sessions 1 through 2, an average of 2 weeks.Learning rate was calculated by using computational modeling of a prediction error formula (e.g., Rescorla \& Wagner, 1972), similar to previous approaches (Barnes-Horowitz, et al., in press; Zbozinek, Perez, et al., 2022). Prior to each exposure, participants rated their expected likelihood that their feared outcome would occur on the upcoming exposure (scores ranged from 0-100). Using computational modeling, these ratings across all exposures were then input into a prediction error formula in order to derive an estimated learning rate (i.e., rate of change in expectancy ratings across exposures) for each participant. Larger, more positive learning rate values reflect greater and faster learning via faster updating of expectancy ratings across exposures.
Outcome measures
| Measure |
Positive Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to identify positive emotional experiences associated with exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
Neutral Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to maintain a neutral, non-emotional stance and focus on overall exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
|---|---|---|
|
Learning Rate
|
.17 unitless
Standard Deviation .19
|
.24 unitless
Standard Deviation .19
|
SECONDARY outcome
Timeframe: Sessions 1 through 2, an average of 2 weeks.Relief rate was calculated by using computational modeling of a prediction error formula (e.g., Rescorla \& Wagner, 1972), similar to previous approaches (Barnes-Horowitz, et al., in press; Zbozinek, Perez, et al., 2022). After each exposure, if the feared outcome did not occur, participants rated the degree of relief they felt that their feared outcome did not occur (scores ranged from 0-100). Using computational modeling, these ratings across all exposures were then input into a prediction error formula in order to derive an estimated relief rate (i.e., rate of change in relief ratings across exposures) for each participant. Larger, more positive relief rate values reflect greater and faster updating of relief ratings across exposures.
Outcome measures
| Measure |
Positive Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to identify positive emotional experiences associated with exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
Neutral Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to maintain a neutral, non-emotional stance and focus on overall exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
|---|---|---|
|
Relief Rate
|
.02 unitless
Standard Deviation .11
|
-.001 unitless
Standard Deviation .06
|
SECONDARY outcome
Timeframe: Baseline through session 2, an average of 2 weeks.Population: 42 participants from each group completed baseline measures. 38 participants in the positive group and 40 in the neutral group completed post-exposure measures (6 lost to follow-up, withdrew from the study, or did not follow study instructions).
Change in self-reported positive affect measured using a visual analog scale (scored from 1-9 where higher scores reflect greater positive affect).
Outcome measures
| Measure |
Positive Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to identify positive emotional experiences associated with exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
Neutral Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to maintain a neutral, non-emotional stance and focus on overall exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
|---|---|---|
|
Change in Positive Affect
Baseline
|
4.9 units on a scale
Standard Deviation 2.2
|
4.5 units on a scale
Standard Deviation 2.0
|
|
Change in Positive Affect
Post-exposure
|
4.2 units on a scale
Standard Deviation 2.3
|
4.4 units on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline through session 2, an average of 2 weeks.Population: 42 participants from each group completed baseline measures. 38 participants in the positive group and 40 in the neutral group completed post-exposure measures (6 lost to follow-up, withdrew from the study, or did not follow study instructions).
Change in self-reported reward sensitivity using the Positive Valence System Scale (PVSS; scored from 21-189 where higher scores reflect greater reward sensitivity).
Outcome measures
| Measure |
Positive Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to identify positive emotional experiences associated with exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
Neutral Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to maintain a neutral, non-emotional stance and focus on overall exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
|---|---|---|
|
Change in Reward Sensitivity
Baseline
|
142.9 units on a scale
Standard Deviation 20.5
|
145.7 units on a scale
Standard Deviation 17.9
|
|
Change in Reward Sensitivity
Post-exposure
|
146.3 units on a scale
Standard Deviation 18.5
|
148.3 units on a scale
Standard Deviation 20.4
|
SECONDARY outcome
Timeframe: Baseline through session 2, an average of 2 weeks.Population: 42 participants from each group completed baseline measures. 38 participants in the positive group and 40 in the neutral group completed post-exposure measures (6 lost to follow-up, withdrew from the study, or did not follow study instructions).
Change in self-reported reward sensitivity was assessed using the Behavioral Activation Scale (BAS). Items were rated on a four-point Likert scale (1 = strongly disagree; 4 = strongly agree) and summed (range of scores = 13-52), where higher scores reflect greater reward sensitivity.
Outcome measures
| Measure |
Positive Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to identify positive emotional experiences associated with exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
Neutral Rehearsal
n=42 Participants
After every two exposure trials, participants will complete a rehearsal exercise prompting reflection of expectancy violation and rehearsal of the inhibitory association between the conditional stimulus (i.e., speech) and the unconditional stimulus (i.e., rejection). During rehearsal, participants are prompted to maintain a neutral, non-emotional stance and focus on overall exposure trial outcomes.
Exposure: All participants complete two study visits, each consisting of 8 exposure trials for durations of 1 minute each, resulting in a total of 16 exposures. For each exposure, participants are assigned a speech topic and given 1 minute to give an unprepared speech to two study confederates.
Rehearsal: After every two exposures, participants will complete a rehearsal task where the participant is asked to use a positive or neutral approach to remember and recount the exposures they have just completed.
|
|---|---|---|
|
Change in Reward Sensitivity
Baseline
|
39.6 units on a scale
Standard Deviation 5.9
|
39.9 units on a scale
Standard Deviation 5.5
|
|
Change in Reward Sensitivity
Post-exposure
|
41.2 units on a scale
Standard Deviation 6.0
|
40.5 units on a scale
Standard Deviation 6.1
|
Adverse Events
Positive Rehearsal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Neutral Rehearsal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nora Barnes-Horowitz
University of California, Los Angeles
Phone: (310) 825-2961
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place