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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH119336 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The investigators plan to conduct a crossover experimental trial examining physiological responses to a socio-evaluative speech task under laboratory conditions. Participants will attend two laboratory sessions. At one session participants will take part in a brief laboratory stress task and at the other participants will rest for the same period. Measures of cardiovascular response will be assessed at both sessions. In addition, blood will be drawn at multiple time points across a 125 minute period to assess changes in circulating levels of cortisol, catecholamines, markers of inflammation and cell free mitochondrial DNA in response to the task. The investigators expect that the stress task will induce a specific increase in ccf-mtDNA, which will statistically mediate subsequent peak circulating Interleukin-6 and Tumor Necrosis Factor-α levels. In secondary analyses, the investigators will examine whether stress-induced increases in circulating cortisol, epinephrine, and norepinephrine levels correlate with increases in ccf-mtDNA. These studies will establish the kinetics and magnitude of psychological stress-induced ccf-mtDNA release, the association with early stress mediators, and whether ccf-mtDNA mediates the inflammatory response to acute stress in humans.
The proposed study will examine physiologic responses to acute psychological challenge in the laboratory among healthy adults. It is widely accepted that there is an increase in circulating markers of inflammation following a single bout of laboratory stress. This increase in systemic inflammation is believed to contribute to the damaging health effect of psychological stress. However, to date, the biological mechanisms by which psychological stress is transduced into inflammation are unclear. The investigators' preliminary evidence suggests that mitochondrion may play a role, with stress-induced increases in circulating levels of mitochondria- derived signaling molecules that are known to modulate immune cell function and the production of pro-inflammatory cytokines.
To test this possibility, the investigators plan to conduct a crossover experimental trial examining physiological responses to an evaluative speech task under laboratory conditions. The investigators have previously used this task to induce physiological arousal. The investigators plan to recruit 60 non-smoking volunteers (50% female, aged 20-50 years) and test these participants on two occasions separated by at least a month. On one occasion the participants will be exposed to the speech task. On the other occasion, the participants will rest quietly for the same period. Conditions will be counterbalanced. At both visits cardiovascular responses (heart rate, blood pressure, and heart rate variability) will be assessed as measures of autonomic activation before, during and after the task period. Participants will also have an intravenous catheter inserted and blood drawn at ten time points over the two hour testing period on each occasion. Blood samples will be sent to laboratories at the University of Pittsburgh and at Columbia University for the assessment of mitochondria-derived signalling molecules, inflammatory markers, and cortisol levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Socio-evaluative Speech Stress, then Control | Experimental | 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. |
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| Control, then Socio-Evaluative Speech Stress | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Socio-evaluative speech task | Behavioral | 5-minute speech task designed to induce physiological arousal in a laboratory setting. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cell-free Mitochondrial DNA | Serum levels of mitochondrial DNA assessed from blood samples | 5 minutes before task, and 5, 10, 20, 30, 45, 60, 75, 90 and 120 minutes after the task. |
| Interleukin-6 | Plasma levels of interleukin-6 | 5 minutes before to 5, 10, 20, 30, 45, 60, 75, 90, 120 post-task periods |
| Tumor Necrosis Factor-alpha | Plasma levels of tumor necrosis factor-alpha | 5 minutes before to 5, 10, 20, 30, 45, 60, 75, 90, 120 post-task periods |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | 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. | last 5 minutes of baseline, 5-min task-period, first two 5 minutes post-task. |
| Systolic Blood Pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna L Marsland, Ph.D. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31029929 | Background | Trumpff C, Marsland AL, Basualto-Alarcon C, Martin JL, Carroll JE, Sturm G, Vincent AE, Mosharov EV, Gu Z, Kaufman BA, Picard M. Acute psychological stress increases serum circulating cell-free mitochondrial DNA. Psychoneuroendocrinology. 2019 Aug;106:268-276. doi: 10.1016/j.psyneuen.2019.03.026. Epub 2019 Mar 28. | |
| 31112904 | Background | Trumpff C, Marsland AL, Sloan RP, Kaufman BA, Picard M. Predictors of ccf-mtDNA reactivity to acute psychological stress identified using machine learning classifiers: A proof-of-concept. Psychoneuroendocrinology. 2019 Sep;107:82-92. doi: 10.1016/j.psyneuen.2019.05.001. Epub 2019 May 7. |
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Individual deidentified participant data (including data dictionaries) will be shared. This includes all of the individual -participant data collected during the trial. In addition, the study protocol will be made available. The Co-Principal Investigators of the study will oversee all matters related to data management and archiving. Final research data will be deposited in the digital repository of the Inter-university Consortium for Political and Social Research (ICPSR), of which the University of Pittsburgh is a member, and which receives partial funding from the NIH.
Data will be made available within nine months to one year after the publication of results bearing on the project's specific aims. The Inter-university Consortium for Political and Social Research (ICPSR) will archive the full dataset and its documentation for the long term, supporting the data through changing technologies, new media, and data formats.
All publications and presentations deriving from the final research data will include information on the location of the data and how it can be accessed, well as acknowledgement of the repository and funding source. The ICPSR has policies and procedures in place that will provide data access to qualified researchers, fully consistent with NIH data sharing policies and applicable laws and regulations.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Session1 |
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| Session 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cell-free Mitochondrial DNA | Serum levels of mitochondrial DNA assessed from blood samples | Posted | Mean | Standard Deviation | Copies per uL | 5 minutes before task, and 5, 10, 20, 30, 45, 60, 75, 90 and 120 minutes after the task. |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Socio-evaluative Speech Stress Session | 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. |
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The trial was disrupted by the COVID-19 pandemic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anna Marsland | University of Pittsburgh | 14123705622 | marsland@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 8, 2020 | Jan 30, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 8, 2020 | Feb 27, 2024 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 1, 2021 | Dec 14, 2022 | ICF_001.pdf |
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The investigators propose a crossover experimental trial examining physiological responses to a socio-evaluative speech task under laboratory conditions. Participants will be tested on two occasions separated by at least 1 month. On one occasion, participants will be exposed to the speech task. On the other occasion, participants will rest quietly for the same period of time with identical assessment in the absence of the stressor. Conditions will be counterbalanced in randomized starting order across subjects.
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Samples of plasma and serum will be identified by participant identification number only. Technicians assessing levels of biological measures in these samples will be blind to condition.
| Control, Quiet Rest | Behavioral | 5-minute quiet rest period. |
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Blood pressure was assessed twice on 10 occasions across the protocol. The two readings on each occasion were averaged. |
| 5 min pre-task and 5, 10, 20, 30, 45, 60, 75, 90, 120 |
| Diastolic Blood Pressure | Diastolic blood pressure was assessed two times on 10 occasions across the protocol. On each occasion, the two measures were averaged. | 5 min pre-task and 5, 10, 20, 30, 45, 60, 75, 90, 120 post task onset |
| Cortisol | Circulating levels of cortisol assessed by ELISA | 5 minutes before to 10, 20, 30, 45, 60 minutes post-task periods |
| Epinephrine | Levels of epinephrine in plasma | 5 minutes before to 5, 10, 20, 30, & 60 minutes post-task periods |
| Norepinephrine | Levels of norepinephrine in plasma | 5 minutes before to 5, 10, 20, 30, & 60 minutes post-task periods |
| Heart Rate Variability | 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 | Pre-task, task, and 1-5 and 6-10 minutes post task |
| Fatigue | 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. | 2 minutes before and 2, 60, and 120 minutes post-task periods |
| Anger | 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. | 2 minutes before and 2-, 60-, and 120-minutes post-task periods |
| Anxious Mood | 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. | 2 minutes before and 2-, 60- and 120-minutes post-task periods |
| Depressed Mood | 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. | 2 minutes before and 2-, 60- and 120-minutes post-task periods |
| Vigor | 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. | 2 minutes before and 2-, 60-, and 120-minutes post-task periods |
| Wellbeing | 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. | 2 minutes before and 2-, 60- and 120-minutes post-task periods |
| Calm Mood | 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. | 2 minutes before and 2-, 60-, and 120-minutes post-task periods |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/M^2 |
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| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
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| Primary | Interleukin-6 | Plasma levels of interleukin-6 | Posted | Mean | Standard Deviation | pg/ml | 5 minutes before to 5, 10, 20, 30, 45, 60, 75, 90, 120 post-task periods |
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| Primary | Tumor Necrosis Factor-alpha | Plasma levels of tumor necrosis factor-alpha | Posted | Mean | Standard Deviation | pg/ml | 5 minutes before to 5, 10, 20, 30, 45, 60, 75, 90, 120 post-task periods |
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| Secondary | Heart Rate | 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. | Posted | Mean | Standard Deviation | Beats per minute | last 5 minutes of baseline, 5-min task-period, first two 5 minutes post-task. |
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| Secondary | Systolic Blood Pressure | Blood pressure was assessed twice on 10 occasions across the protocol. The two readings on each occasion were averaged. | Posted | Mean | Standard Error | mmHg | 5 min pre-task and 5, 10, 20, 30, 45, 60, 75, 90, 120 |
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| Secondary | Diastolic Blood Pressure | Diastolic blood pressure was assessed two times on 10 occasions across the protocol. On each occasion, the two measures were averaged. | Posted | Mean | Standard Deviation | mmHg | 5 min pre-task and 5, 10, 20, 30, 45, 60, 75, 90, 120 post task onset |
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| Secondary | Cortisol | Circulating levels of cortisol assessed by ELISA | Posted | Mean | Standard Deviation | ug/dL | 5 minutes before to 10, 20, 30, 45, 60 minutes post-task periods |
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| Secondary | Epinephrine | Levels of epinephrine in plasma | Posted | Mean | Standard Deviation | pg/ml | 5 minutes before to 5, 10, 20, 30, & 60 minutes post-task periods |
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| Secondary | Norepinephrine | Levels of norepinephrine in plasma | Posted | Mean | Standard Deviation | pg/ml | 5 minutes before to 5, 10, 20, 30, & 60 minutes post-task periods |
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| Secondary | Heart Rate Variability | 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 | Posted | Mean | Standard Deviation | log normal milliseconds | Pre-task, task, and 1-5 and 6-10 minutes post task |
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| Secondary | Fatigue | 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. | Posted | Mean | Standard Deviation | score on scale | 2 minutes before and 2, 60, and 120 minutes post-task periods |
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| Secondary | Anger | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 minutes before and 2-, 60-, and 120-minutes post-task periods |
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| Secondary | Anxious Mood | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 minutes before and 2-, 60- and 120-minutes post-task periods |
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| Secondary | Depressed Mood | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 minutes before and 2-, 60- and 120-minutes post-task periods |
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| Secondary | Vigor | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 minutes before and 2-, 60-, and 120-minutes post-task periods |
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| Secondary | Wellbeing | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 minutes before and 2-, 60- and 120-minutes post-task periods |
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| Secondary | Calm Mood | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 minutes before and 2-, 60-, and 120-minutes post-task periods |
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| 0 |
| 63 |
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| 63 |
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| 63 |
| EG001 | Control Session | 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. | 0 | 61 | 0 | 61 | 0 | 61 |
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