Trial Outcomes & Findings for Biological Response to Brief Psychological Challenge (NCT NCT04078035)

NCT ID: NCT04078035

Last Updated: 2024-03-01

Results Overview

Serum levels of mitochondrial DNA assessed from blood samples

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: 5 minutes before task, and 5, 10, 20, 30, 45, 60, 75, 90 and 120 minutes after the task.
• Results posted on: 2024-03-01

Participant Flow

Participants were recruited into this study between 7/23/2020 and 12/17/2021. Healthy volunteers were recruited from advertisements places around campus and through "Pitt+Me," a registry of individuals interested in participating in research taking place at the University of Pittsburgh.

Participants were scheduled for a screening telephone call to determine eligibility. Eligible participants were rescreened at 1st study visit and excluded if they did not meet eligibility criteria. We also excluded individuals on whom we could not insert a functioning intravenous catheter at the first study visit.

Participant milestones

Measure	Socio-evaluative Speech Stress, Then Control Participants will attend two laboratory sessions. At the first session, participants will complete a socio-evaluative speech task, which is a widely used, highly effective way to investigate stress responses in a laboratory setting. Participants will prepare and deliver a brief, 3-minute speech defending themselves against an alleged transgression (e.g., running a stop sign). The speech will be delivered in front of a video camera, a mirror and an audience (the interviewer and another staff member). Participants will be told that their non-verbal behaviors are being evaluated. At the second session, participants will rest quietly for the same period as the speech task, in the absence of the stressor. Socio-evaluative speech task: 5-minute speech task designed to induce physiological arousal in a laboratory setting. Control, Quiet Rest: 5-minute quiet rest period.	Control, Then Socio-Evaluative Speech Stress Participants will attend two laboratory sessions. At the first session, participants will rest quietly for 5 minutes. At the second session, participants will complete a socio-evaluative speech task, which is a widely used, highly effective way to investigate stress responses in a laboratory setting. Participants will prepare and deliver a brief, 3-minute speech defending themselves against an alleged transgression (e.g., running a stop sign). The speech will be delivered in front of a video camera, a mirror and an audience (the interviewer and another staff member). Participants will be told that their non-verbal behaviors are being evaluated. Socio-evaluative speech task: 5-minute speech task designed to induce physiological arousal in a laboratory setting. Control, Quiet Rest: 5-minute quiet rest period.
Session1 STARTED	36	36
Session1 COMPLETED	36	36
Session1 NOT COMPLETED	0	0
Session 2 STARTED	36	36
Session 2 COMPLETED	25	27
Session 2 NOT COMPLETED	11	9

Reasons for withdrawal

Measure	Socio-evaluative Speech Stress, Then Control Participants will attend two laboratory sessions. At the first session, participants will complete a socio-evaluative speech task, which is a widely used, highly effective way to investigate stress responses in a laboratory setting. Participants will prepare and deliver a brief, 3-minute speech defending themselves against an alleged transgression (e.g., running a stop sign). The speech will be delivered in front of a video camera, a mirror and an audience (the interviewer and another staff member). Participants will be told that their non-verbal behaviors are being evaluated. At the second session, participants will rest quietly for the same period as the speech task, in the absence of the stressor. Socio-evaluative speech task: 5-minute speech task designed to induce physiological arousal in a laboratory setting. Control, Quiet Rest: 5-minute quiet rest period.	Control, Then Socio-Evaluative Speech Stress Participants will attend two laboratory sessions. At the first session, participants will rest quietly for 5 minutes. At the second session, participants will complete a socio-evaluative speech task, which is a widely used, highly effective way to investigate stress responses in a laboratory setting. Participants will prepare and deliver a brief, 3-minute speech defending themselves against an alleged transgression (e.g., running a stop sign). The speech will be delivered in front of a video camera, a mirror and an audience (the interviewer and another staff member). Participants will be told that their non-verbal behaviors are being evaluated. Socio-evaluative speech task: 5-minute speech task designed to induce physiological arousal in a laboratory setting. Control, Quiet Rest: 5-minute quiet rest period.
Session 2 Lost to Follow-up	3	1
Session 2 Unable to insert IV - participant elected to withdraw	8	8

Baseline Characteristics

Biological Response to Brief Psychological Challenge

Baseline characteristics by cohort

Measure	Socio-evaluative Speech Stress, Then Control n=36 Participants Participants will attend two laboratory sessions. At the first session, participants will complete a socio-evaluative speech task, which is a widely used, highly effective way to investigate stress responses in a laboratory setting. Participants will prepare and deliver a brief, 3-minute speech defending themselves against an alleged transgression (e.g., running a stop sign). The speech will be delivered in front of a video camera, a mirror and an audience (the interviewer and another staff member). Participants will be told that their non-verbal behaviors are being evaluated. At the second session, participants will rest quietly for the same period as the speech task, in the absence of the stressor. Socio-evaluative speech task: 5-minute speech task designed to induce physiological arousal in a laboratory setting. Control, Quiet Rest: 5-minute quiet rest period.	Control, Then Socio-Evaluative Speech Stress n=36 Participants Participants will attend two laboratory sessions. At the first session, participants will rest quietly for 5 minutes. At the second session, participants will complete a socio-evaluative speech task, which is a widely used, highly effective way to investigate stress responses in a laboratory setting. Participants will prepare and deliver a brief, 3-minute speech defending themselves against an alleged transgression (e.g., running a stop sign). The speech will be delivered in front of a video camera, a mirror and an audience (the interviewer and another staff member). Participants will be told that their non-verbal behaviors are being evaluated. Socio-evaluative speech task: 5-minute speech task designed to induce physiological arousal in a laboratory setting. Control, Quiet Rest: 5-minute quiet rest period.	Total n=72 Participants Total of all reporting groups
Age, Continuous	32 Years STANDARD_DEVIATION 9 • n=5 Participants	31 Years STANDARD_DEVIATION 8 • n=7 Participants	31 Years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	19 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	17 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	36 participants n=7 Participants	72 participants n=5 Participants
Body Mass Index	24.30 kg/M^2 STANDARD_DEVIATION 4.27 • n=5 Participants	22.61 kg/M^2 STANDARD_DEVIATION 2.68 • n=7 Participants	23.46 kg/M^2 STANDARD_DEVIATION 3.64 • n=5 Participants
Systolic Blood Pressure	113.05 mmHg STANDARD_DEVIATION 7.82 • n=5 Participants	108.06 mmHg STANDARD_DEVIATION 10.53 • n=7 Participants	110.78 mmHg STANDARD_DEVIATION 9.42 • n=5 Participants
Diastolic Blood Pressure	68.92 mmHg STANDARD_DEVIATION 6.58 • n=5 Participants	65.85 mmHg STANDARD_DEVIATION 6.73 • n=7 Participants	67.42 mmHg STANDARD_DEVIATION 6.75 • n=5 Participants

PRIMARY outcome

Timeframe: 5 minutes before task, and 5, 10, 20, 30, 45, 60, 75, 90 and 120 minutes after the task.

Serum levels of mitochondrial DNA assessed from blood samples

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Cell-free Mitochondrial DNA 5 min pre-task	165.79 Copies per uL Standard Deviation 143.01	405.56 Copies per uL Standard Deviation 1218.33
Cell-free Mitochondrial DNA 5 min	175.45 Copies per uL Standard Deviation 144.03	164.45 Copies per uL Standard Deviation 133.03
Cell-free Mitochondrial DNA 10 min	414.74 Copies per uL Standard Deviation 1942.78	296.62 Copies per uL Standard Deviation 629.78
Cell-free Mitochondrial DNA 20 min	153.37 Copies per uL Standard Deviation 144.03	213.27 Copies per uL Standard Deviation 511.28
Cell-free Mitochondrial DNA 30 min	151.50 Copies per uL Standard Deviation 124.64	163.41 Copies per uL Standard Deviation 147.62
Cell-free Mitochondrial DNA 45 min	171.53 Copies per uL Standard Deviation 178.85	172.03 Copies per uL Standard Deviation 155.38
Cell-free Mitochondrial DNA 60 min	150.76 Copies per uL Standard Deviation 93.06	215.58 Copies per uL Standard Deviation 437.87
Cell-free Mitochondrial DNA 75 min	183.87 Copies per uL Standard Deviation 216.89	255.99 Copies per uL Standard Deviation 549.68
Cell-free Mitochondrial DNA 90 min	187.20 Copies per uL Standard Deviation 202.77	223.99 Copies per uL Standard Deviation 272.97
Cell-free Mitochondrial DNA 120 min	161.19 Copies per uL Standard Deviation 149.77	232.64 Copies per uL Standard Deviation 279.89

PRIMARY outcome

Timeframe: 5 minutes before to 5, 10, 20, 30, 45, 60, 75, 90, 120 post-task periods

Plasma levels of interleukin-6

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Interleukin-6 5 mins pre-task	1.52 pg/ml Standard Deviation 1.29	1.40 pg/ml Standard Deviation 0.99
Interleukin-6 5 min	1.76 pg/ml Standard Deviation 1.31	1.58 pg/ml Standard Deviation 0.94
Interleukin-6 10 min	1.61 pg/ml Standard Deviation 1.24	1.52 pg/ml Standard Deviation 0.94
Interleukin-6 20 min	2.05 pg/ml Standard Deviation 1.49	1.78 pg/ml Standard Deviation 1.01
Interleukin-6 30 min	2.01 pg/ml Standard Deviation 1.44	1.85 pg/ml Standard Deviation 1.29
Interleukin-6 45 min	2.30 pg/ml Standard Deviation 1.70	2.15 pg/ml Standard Deviation 1.32
Interleukin-6 60 min	2.50 pg/ml Standard Deviation 1.76	2.27 pg/ml Standard Deviation 1.34
Interleukin-6 75 min	3.28 pg/ml Standard Deviation 3.61	3.06 pg/ml Standard Deviation 2.84
Interleukin-6 90 min	3.80 pg/ml Standard Deviation 3.78	2.91 pg/ml Standard Deviation 1.97
Interleukin-6 120 min	4.50 pg/ml Standard Deviation 3.92	4.72 pg/ml Standard Deviation 5.31

PRIMARY outcome

Timeframe: 5 minutes before to 5, 10, 20, 30, 45, 60, 75, 90, 120 post-task periods

Plasma levels of tumor necrosis factor-alpha

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Tumor Necrosis Factor-alpha 5 min pre-task	5.92 pg/ml Standard Deviation 2.21	6.10 pg/ml Standard Deviation 2.21
Tumor Necrosis Factor-alpha 5 min	6.62 pg/ml Standard Deviation 1.90	6.81 pg/ml Standard Deviation 2.79
Tumor Necrosis Factor-alpha 10 min	6.59 pg/ml Standard Deviation 1.84	6.28 pg/ml Standard Deviation 1.92
Tumor Necrosis Factor-alpha 20 min	6.70 pg/ml Standard Deviation 1.72	6.79 pg/ml Standard Deviation 2.76
Tumor Necrosis Factor-alpha 30 min	6.45 pg/ml Standard Deviation 1.82	6.35 pg/ml Standard Deviation 1.89
Tumor Necrosis Factor-alpha 45 min	6.61 pg/ml Standard Deviation 1.76	6.74 pg/ml Standard Deviation 2.63
Tumor Necrosis Factor-alpha 60 min	6.41 pg/ml Standard Deviation 1.65	6.52 pg/ml Standard Deviation 2.51
Tumor Necrosis Factor-alpha 75 min	6.58 pg/ml Standard Deviation 1.68	6.79 pg/ml Standard Deviation 2.64
Tumor Necrosis Factor-alpha 90 min	3.78 pg/ml Standard Deviation 6.68	6.75 pg/ml Standard Deviation 1.74
Tumor Necrosis Factor-alpha 120 min	3.92 pg/ml Standard Deviation 6.43	6.66 pg/ml Standard Deviation 2.62

SECONDARY outcome

Timeframe: last 5 minutes of baseline, 5-min task-period, first two 5 minutes post-task.

Continuous measurement of heart rate was averaged across 4 periods: last 5 minutes of baseline, 5-min task-period, first two 5 minutes post-task.

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Heart Rate Mean of 5 min pre-task	65.60 Beats per minute Standard Deviation 9.57	66.76 Beats per minute Standard Deviation 9.53
Heart Rate mean of 5 min task period	79.27 Beats per minute Standard Deviation 14.44	66.36 Beats per minute Standard Deviation 9.46
Heart Rate mean of min 1-5 post-task	71.37 Beats per minute Standard Deviation 10.83	67.43 Beats per minute Standard Deviation 9.20
Heart Rate mean of min 6-10 post-task	66.00 Beats per minute Standard Deviation 9.46	65.03 Beats per minute Standard Deviation 9.24

SECONDARY outcome

Timeframe: 5 min pre-task and 5, 10, 20, 30, 45, 60, 75, 90, 120

Blood pressure was assessed twice on 10 occasions across the protocol. The two readings on each occasion were averaged.

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Systolic Blood Pressure 5 min pre-task	111.18 mmHg Standard Error 9.47	109.43 mmHg Standard Error 10.18
Systolic Blood Pressure 5 min post-task	120.29 mmHg Standard Error 11.71	110.70 mmHg Standard Error 9.46
Systolic Blood Pressure 10 min post-task	120.02 mmHg Standard Error 12.58	109.38 mmHg Standard Error 9.95
Systolic Blood Pressure 20 min post-task	131.55 mmHg Standard Error 18.09	109.23 mmHg Standard Error 10.43
Systolic Blood Pressure 30 min post-task	135.63 mmHg Standard Error 16.62	108.98 mmHg Standard Error 10.15
Systolic Blood Pressure 45 min post-task	133.42 mmHg Standard Error 14.32	109.14 mmHg Standard Error 10.12
Systolic Blood Pressure 60 min post-task	125.43 mmHg Standard Error 13.54	109.46 mmHg Standard Error 10.59
Systolic Blood Pressure 75 min post-task	120.61 mmHg Standard Error 12.45	109.59 mmHg Standard Error 12.07
Systolic Blood Pressure 90 min post-task	117.15 mmHg Standard Error 10.58	109.29 mmHg Standard Error 10.12
Systolic Blood Pressure 120 min post-tsk	115.45 mmHg Standard Error 12.59	108.32 mmHg Standard Error 12.25

SECONDARY outcome

Timeframe: 5 min pre-task and 5, 10, 20, 30, 45, 60, 75, 90, 120 post task onset

Diastolic blood pressure was assessed two times on 10 occasions across the protocol. On each occasion, the two measures were averaged.

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Diastolic Blood Pressure 5 min pre-task	67.69 mmHg Standard Deviation 9.47	65.74 mmHg Standard Deviation 10.18
Diastolic Blood Pressure 5 min post-task onset	72.00 mmHg Standard Deviation 11.71	66.02 mmHg Standard Deviation 9.46
Diastolic Blood Pressure 10 min post task onset	72.65 mmHg Standard Deviation 12.58	65.17 mmHg Standard Deviation 9.95
Diastolic Blood Pressure 20 min post task onset	79.58 mmHg Standard Deviation 18.09	65.27 mmHg Standard Deviation 10.43
Diastolic Blood Pressure 30 min post task onset	81.57 mmHg Standard Deviation 16.62	66.42 mmHg Standard Deviation 10.15
Diastolic Blood Pressure 45 min post task onset	79.03 mmHg Standard Deviation 14.32	65.71 mmHg Standard Deviation 10.12
Diastolic Blood Pressure 60 min post task onset	71.80 mmHg Standard Deviation 13.54	66.17 mmHg Standard Deviation 10.59
Diastolic Blood Pressure 75 min post task onset	68.02 mmHg Standard Deviation 12.45	65.86 mmHg Standard Deviation 12.07
Diastolic Blood Pressure 90 min post task onset	66.37 mmHg Standard Deviation 10.58	64.34 mmHg Standard Deviation 10.12
Diastolic Blood Pressure 120 min post task onset	66.30 mmHg Standard Deviation 12.59	64.10 mmHg Standard Deviation 12.25

SECONDARY outcome

Timeframe: 5 minutes before to 10, 20, 30, 45, 60 minutes post-task periods

Circulating levels of cortisol assessed by ELISA

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Cortisol 5 min pre-task	1.50 ug/dL Standard Deviation 0.72	1.48 ug/dL Standard Deviation 0.76
Cortisol 10 min post task onset	1.46 ug/dL Standard Deviation 0.76	1.30 ug/dL Standard Deviation 0.62
Cortisol 20 min post task onset	1.57 ug/dL Standard Deviation 0.86	1.30 ug/dL Standard Deviation 0.63
Cortisol 30 min post task onset	1.49 ug/dL Standard Deviation 0.64	1.24 ug/dL Standard Deviation 0.64
Cortisol 45 min post task onset	1.43 ug/dL Standard Deviation 0.62	1.24 ug/dL Standard Deviation 0.66
Cortisol 60 min post task onset	1.35 ug/dL Standard Deviation 0.72	1.18 ug/dL Standard Deviation 0.60

SECONDARY outcome

Timeframe: 5 minutes before to 5, 10, 20, 30, & 60 minutes post-task periods

Levels of epinephrine in plasma

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Epinephrine 5 min pre-task	50.56 pg/ml Standard Deviation 20.09	48.62 pg/ml Standard Deviation 21.67
Epinephrine 5 min post task onset	54.01 pg/ml Standard Deviation 23.87	47.46 pg/ml Standard Deviation 21.19
Epinephrine 10 min post task onset	49.81 pg/ml Standard Deviation 18.69	52.48 pg/ml Standard Deviation 28.98
Epinephrine 20 min post task onset	47.95 pg/ml Standard Deviation 18.12	45.16 pg/ml Standard Deviation 17.38
Epinephrine 30 min post task onset	47.08 pg/ml Standard Deviation 16.63	44.26 pg/ml Standard Deviation 18.35
Epinephrine 60 min post task onset	48.34 pg/ml Standard Deviation 17.78	41.64 pg/ml Standard Deviation 16.43

SECONDARY outcome

Timeframe: 5 minutes before to 5, 10, 20, 30, & 60 minutes post-task periods

Levels of norepinephrine in plasma

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Norepinephrine 5 min pre-task	522.86 pg/ml Standard Deviation 228.82	480.48 pg/ml Standard Deviation 175.92
Norepinephrine 5 min post-task onset	540.39 pg/ml Standard Deviation 178.62	485.44 pg/ml Standard Deviation 157.60
Norepinephrine 10 min post-task	526.93 pg/ml Standard Deviation 187.47	484.38 pg/ml Standard Deviation 151.81
Norepinephrine 20 min post-task	494.17 pg/ml Standard Deviation 173.34	470.70 pg/ml Standard Deviation 172.50
Norepinephrine 30 min post-task	477.84 pg/ml Standard Deviation 191.16	476.14 pg/ml Standard Deviation 155.51
Norepinephrine 60 min post-task	472.74 pg/ml Standard Deviation 156.83	461.97 pg/ml Standard Deviation 160.05

SECONDARY outcome

Timeframe: Pre-task, task, and 1-5 and 6-10 minutes post task

Interbeat intervals of heart rate assessed by 3-lead EKG. Measures were taken continuously from 5 minutes before the task to 10 minutes after the task. Rsults were then averaged across 4 periods: 5 minutes prior to the task, the 5-minute task period, and 5-, and 10-minutes post task

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Heart Rate Variability Mean across minutes 1-5 post-task	6.18 log normal milliseconds Standard Deviation 0.97	6.37 log normal milliseconds Standard Deviation 0.85
Heart Rate Variability Mean across 6-10 minutes post-task	6.30 log normal milliseconds Standard Deviation 0.93	6.43 log normal milliseconds Standard Deviation 0.91
Heart Rate Variability Mean across 5 min pre-task	6.50 log normal milliseconds Standard Deviation 1.05	6.58 log normal milliseconds Standard Deviation 0.81
Heart Rate Variability Mean across 5 min task period	5.94 log normal milliseconds Standard Deviation 0.96	6.50 log normal milliseconds Standard Deviation 0.92

SECONDARY outcome

Timeframe: 2 minutes before and 2, 60, and 120 minutes post-task periods

Momentary assessment of fatigue, measured as score on the fatigue subscale on the brief Profile of Mood States questionnaire. Scores range from 0 - 20, with higher scores reflecting more fatigue.

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Fatigue Pre-task	4.76 score on scale Standard Deviation 4.02	5.47 score on scale Standard Deviation 3.72
Fatigue post-task	2.59 score on scale Standard Deviation 2.75	5.36 score on scale Standard Deviation 3.86
Fatigue 60 min post task onset	5.79 score on scale Standard Deviation 4.15	6.48 score on scale Standard Deviation 4.62
Fatigue 120 min post task onset	5.50 score on scale Standard Deviation 4.50	5.41 score on scale Standard Deviation 4.36

SECONDARY outcome

Timeframe: 2 minutes before and 2-, 60-, and 120-minutes post-task periods

Momentary assessment of anger, measured as score on the anger subscale on the brief Profile of Mood States questionnaire in response to the task periods. Scores range from 0 - 12, with higher scores reflecting more anger.

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Anger Pre-task	0.30 score on a scale Standard Deviation 1.03	0.08 score on a scale Standard Deviation 0.42
Anger 2 min post-task	0.70 score on a scale Standard Deviation 1.57	0.20 score on a scale Standard Deviation 1.05
Anger 60 min post task onset	0.49 score on a scale Standard Deviation 1.39	0.16 score on a scale Standard Deviation 0.72
Anger 120 min post task onset	0.45 score on a scale Standard Deviation 1.51	0.14 score on a scale Standard Deviation 0.59

SECONDARY outcome

Timeframe: 2 minutes before and 2-, 60- and 120-minutes post-task periods

Momentary assessment of anxious mood, measured as score on the anxiety subscale on the brief Profile of Mood States questionnaire in response to the task periods. Scores range from 0 - 16, with higher scores reflecting more anxious mood.

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Anxious Mood 2 min pre-task	1.44 score on a scale Standard Deviation 2.13	1.35 score on a scale Standard Deviation 1.97
Anxious Mood 2 min post-task	3.21 score on a scale Standard Deviation 2.78	0.93 score on a scale Standard Deviation 1.97
Anxious Mood 60 min post task onset	1.56 score on a scale Standard Deviation 2.21	1.24 score on a scale Standard Deviation 2.30
Anxious Mood 120 min post task onset	1.29 score on a scale Standard Deviation 2.18	1.02 score on a scale Standard Deviation 2.46

SECONDARY outcome

Timeframe: 2 minutes before and 2-, 60- and 120-minutes post-task periods

Momentary assessment of depressed mood, measured as score on the depression subscale on the brief Profile of Mood States questionnaire in response to the task periods. Scores range from 0 - 12, with higher scores reflecting more depressed mood.

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Depressed Mood 2 min pre-task	0.32 score on a scale Standard Deviation 0.91	0.23 score on a scale Standard Deviation 0.79
Depressed Mood 2 min post-task	0.46 score on a scale Standard Deviation 1.20	0.27 score on a scale Standard Deviation 0.94
Depressed Mood 60 min post task onset	0.64 score on a scale Standard Deviation 1.34	0.29 score on a scale Standard Deviation 0.94
Depressed Mood 120 min post task onset	0.41 score on a scale Standard Deviation 1.12	0.25 score on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: 2 minutes before and 2-, 60-, and 120-minutes post-task periods

Momentary assessment of vigor, measured as score on the vigor subscale on the brief Profile of Mood States questionnaire in response to the task periods. Scores range from 0 - 12, with higher scores reflecting more vigor.

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Vigor 2 min pre-task	1.84 score on a scale Standard Deviation 1.97	1.65 score on a scale Standard Deviation 1.87
Vigor 2 min post-task	3.19 score on a scale Standard Deviation 2.28	1.54 score on a scale Standard Deviation 1.81
Vigor 60 min post task onset	1.39 score on a scale Standard Deviation 1.89	1.03 score on a scale Standard Deviation 1.53
Vigor 120 min post task onset	1.91 score on a scale Standard Deviation 2.30	1.66 score on a scale Standard Deviation 2.09

SECONDARY outcome

Timeframe: 2 minutes before and 2-, 60- and 120-minutes post-task periods

Momentary assessment of wellbeing, measured as score on the wellbeing subscale on the brief Profile of Mood States questionnaire in response to the task periods. Scores range from 0 - 12, with higher scores reflecting more wellbeing.

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Wellbeing 2 min pre-task	4.25 score on a scale Standard Deviation 2.11	4.10 score on a scale Standard Deviation 2.04
Wellbeing 2 min post-task	3.56 score on a scale Standard Deviation 2.19	3.93 score on a scale Standard Deviation 2.34
Wellbeing 60-min post-task	3.61 score on a scale Standard Deviation 2.36	3.81 score on a scale Standard Deviation 2.31
Wellbeing 120-min post-task	3.93 score on a scale Standard Deviation 2.70	3.82 score on a scale Standard Deviation 2.52

SECONDARY outcome

Timeframe: 2 minutes before and 2-, 60-, and 120-minutes post-task periods

Momentary assessment of calm mood, measured as score on the calm subscale on the brief Profile of Mood States questionnaire in response to the task periods. Scores range from 0 - 16, with higher scores reflecting more calm mood.

Outcome measures

Measure	Socio-evaluative Speech Stress Session n=63 Participants Participants attended two laboratory sessions order of these sessions was counterbalanced. At one of the sessions, they completed a 5-minute socio-evaluative speech task defending themselves against an alleged transgression (e.g., running a stop sign). Outcomes in this condition include responses to this stressor.	Control Session n=61 Participants Participants attended two laboratory sessions. Order of sessions was counterbalanced. Presented outcome data are for the control condition only. Participants rested quietly for the 5-minute task period.
Calm Mood 2 min pre-task	9.09 score on a scale Standard Deviation 2.85	9.38 score on a scale Standard Deviation 2.90
Calm Mood 2 min post-task	5.87 score on a scale Standard Deviation 2.84	8.83 score on a scale Standard Deviation 3.39
Calm Mood 60- min post task onset	7.59 score on a scale Standard Deviation 3.40	8.29 score on a scale Standard Deviation 2.91
Calm Mood 120 min post task onset	7.68 score on a scale Standard Deviation 3.18	7.63 score on a scale Standard Deviation 3.50

Adverse Events

Socio-evaluative Speech Stress Session

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Session

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

Dr. Anna Marsland

University of Pittsburgh

Phone: 14123705622

Email: marsland@pitt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place