Acute Inflammatory Response to Psychological StressNCT04078035

Biological Response to Brief Psychological Challenge

A study testing Socio-evaluative speech task in people with Acute Inflammatory Response to Psychological Stress, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Acute Inflammatory Response to Psychological Stress
What is being tested?: Socio-evaluative speech task
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: 23 Jul 2020to 31 Jan 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Generally healthy
Non-smokers/illicit drug users
Blood pressure below 140/90
Weight > 110 lbs
BMI < 30
Fluent in English

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Women -- regular menstrual cycles over the past 12 months (defined as 21- 35 days in length)
Able and willing to give informed consent
Willing to abstain from alcohol and vigorous exercise for 24 hours, from food and drinks (other than water) for 3 hours and from non-prescription medications (other than oral contraception) for 2 days before testing.
Willing to attend two laboratory stress testing sessions, give blood though an intravenous catheter, undergo medical evaluation and complete psychosocial questionnaires.

Who cannot join

Reported history of chronic systemic immune, metabolic or mitochondrial diseases, or chronic diseases that influence the central nervous, autonomic nervous or neuroendocrine systems, e.g., autoimmune disease, chronic infections, cardiovascular disease, diabetes, chronic kidney or liver disease, cancer treatment.
Reported psychiatric history of schizophrenia or other psychotic illness, or mood disorder.
Resting blood pressure > 140/90 mmHg at baseline testing.
Weight < 110 lbs
BMI equal to or greater than 30
Report currently taking glucocorticoid, anti-inflammatory, anti-retroviral, immunosuppressant, insulin, antiarrhythmic, antihypertensive, oral hypoglycemic, antidepressant, benzodiazepine or prescription weight loss medications or other medications known to influence the immune, autonomic or neuroendocrine systems.

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For women - Post-menopausal or irregular menstrual cycles over the past 12 months. Report current pregnancy or lactation.
Current smokers (defined as having smoked a cigarette in the previous 3 months).
Current illicit drug use (defined as reported use of illicit drugs such as marijuana, cocaine or heroin in the previous 3 months).
Not fluent in English (have used English in everyday speaking and reading for at least 10 years)
Unable or unwilling to give informed consent
Unwilling to abstain from alcohol and vigorous exercise for 24 hours, from food and drinks (other than water) for 3 hours and from non-prescription medications (other than oral contraception) for 2 days prior to testing.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Transduction of Psychological Stress Into Systematic Inflammation by Mitochondrial DNA Signaling

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.

Read the detailed description

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.

Conditions: Acute Inflammatory Response to Psychological Stress
Being tested: Socio-evaluative speech task, Control, Quiet Rest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Socio-evaluative speech taskBehavioural
5-minute speech task designed to induce physiological arousal in a laboratory setting.
Control, Quiet RestBehavioural
5-minute quiet rest period.

Study groups in NCT04078035
Study group	Role	What they receive
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. Receives: Behavioral: Socio-evaluative speech task; Behavioral: Control, Quiet Rest
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. Receives: Behavioral: Socio-evaluative speech task; Behavioral: Control, Quiet Rest

What is being measured

The primary outcome is the main question the study is designed to answer.

Cell-free Mitochondrial DNA
Serum levels of mitochondrial DNA assessed from blood samples
Measured: 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
Measured: 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
Measured: 5 minutes before to 5, 10, 20, 30, 45, 60, 75, 90, 120 post-task periods

Secondary outcomes (14)

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.
Measured: last 5 minutes of baseline, 5-min task-period, first two 5 minutes post-task.
Systolic Blood Pressure
Blood pressure was assessed twice on 10 occasions across the protocol. The two readings on each occasion were averaged.
Measured: 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.
Measured: 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
Measured: 5 minutes before to 10, 20, 30, 45, 60 minutes post-task periods
Epinephrine
Levels of epinephrine in plasma
Measured: 5 minutes before to 5, 10, 20, 30, & 60 minutes post-task periods
Norepinephrine
Levels of norepinephrine in plasma
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 minutes before and 2-, 60-, and 120-minutes post-task periods

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 202031 Jan 2022

First posted4 Sep 2019
Study start23 Jul 2020
Primary completion31 Jan 2022
Study completion31 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Acute Inflammatory Response to Psychological StressStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: 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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04078035
Sponsor's protocol ID: STUDY19020140
Other IDs: R01MH119336
Status last verified: Feb 2024
First submitted: 28 Aug 2019
Last updated: 1 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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.
PubMed 31029929
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.
PubMed 31112904

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transduction of Psychological Stress Into Systematic Inflammation by Mitochondrial DNA Signaling
ClinicalTrials.gov ID: NCT04078035
Acronym / sponsor ID: STUDY19020140
Conditions: Acute Inflammatory Response to Psychological Stress
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 23 Jul 2020 (actual)
Primary completion: 31 Jan 2022 (actual)
Study completion: 31 Jan 2022 (actual)
First posted: 4 Sep 2019 (actual)
Results: Posted 1 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Socio-evaluative Speech Stress, then Control	Experimental	Behavioral: Socio-evaluative speech task, Behavioral: Control, Quiet RestParticipants 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.
Control, then Socio-Evaluative Speech Stress	Experimental	Behavioral: Socio-evaluative speech task, Behavioral: Control, Quiet RestParticipants 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.

Who may qualify

Ages: 20 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Generally healthy
Non-smokers/illicit drug users
Blood pressure below 140/90
Weight > 110 lbs
BMI < 30

Key exclusion criteria (12 listed)

Reported history of chronic systemic immune, metabolic or mitochondrial diseases, or chronic diseases that influence the central nervous, autonomic nervous or neuroendocrine systems, e.g., autoimmune disease, chronic infections, cardiovascular disease, diabetes, chronic kidney or liver disease, cancer treatment.
Reported psychiatric history of schizophrenia or other psychotic illness, or mood disorder.
Resting blood pressure > 140/90 mmHg at baseline testing.
Weight < 110 lbs
BMI equal to or greater than 30

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Socio-evaluative speech task5-minute speech task designed to induce physiological arousal in a laboratory setting.	Behavioural	Control, then Socio-Evaluative Speech Stress, Socio-evaluative Speech Stress, then Control
Control, Quiet Rest5-minute quiet rest period.	Behavioural	Control, then Socio-Evaluative Speech Stress, Socio-evaluative Speech Stress, then Control

Primary outcome

Cell-free Mitochondrial DNA
Time frame: 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
Interleukin-6
Time frame: 5 minutes before to 5, 10, 20, 30, 45, 60, 75, 90, 120 post-task periods
Plasma levels of interleukin-6
Tumor Necrosis Factor-alpha
Time frame: 5 minutes before to 5, 10, 20, 30, 45, 60, 75, 90, 120 post-task periods
Plasma levels of tumor necrosis factor-alpha

14 secondary outcomes

Heart Rate
Time frame: last 5 minutes of baseline, 5-min task-period, first two 5 minutes post-task.
Systolic Blood Pressure
Time frame: 5 min pre-task and 5, 10, 20, 30, 45, 60, 75, 90, 120
Diastolic Blood Pressure
Time frame: 5 min pre-task and 5, 10, 20, 30, 45, 60, 75, 90, 120 post task onset
Cortisol
Time frame: 5 minutes before to 10, 20, 30, 45, 60 minutes post-task periods
Epinephrine
Time frame: 5 minutes before to 5, 10, 20, 30, & 60 minutes post-task periods
Norepinephrine
Time frame: 5 minutes before to 5, 10, 20, 30, & 60 minutes post-task periods
Heart Rate Variability
Time frame: Pre-task, task, and 1-5 and 6-10 minutes post task
Fatigue
Time frame: 2 minutes before and 2, 60, and 120 minutes post-task periods
Anger
Time frame: 2 minutes before and 2-, 60-, and 120-minutes post-task periods
Anxious Mood
Time frame: 2 minutes before and 2-, 60- and 120-minutes post-task periods
Depressed Mood
Time frame: 2 minutes before and 2-, 60- and 120-minutes post-task periods
Vigor
Time frame: 2 minutes before and 2-, 60-, and 120-minutes post-task periods
Wellbeing
Time frame: 2 minutes before and 2-, 60- and 120-minutes post-task periods
Calm Mood
Time frame: 2 minutes before and 2-, 60-, and 120-minutes post-task periods

Results and safety

Results posted to the registry on 1 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Socio-evaluative Speech Stress, Then Control	36	36
Control, Then Socio-Evaluative Speech Stress	36	36

Primary outcome: Cell-free Mitochondrial DNA

Time frame: 5 minutes before task, and 5, 10, 20, 30, 45, 60, 75, 90 and 120 minutes after the task.. Mean (Standard Deviation). Unit: Copies per uL

Measure	Socio-evaluative Speech Stress Session n = 63	Control Session n = 61
5 min pre-task	165.79 (143.01)	405.56 (1218.33)
5 min	175.45 (144.03)	164.45 (133.03)
10 min	414.74 (1942.78)	296.62 (629.78)
20 min	153.37 (144.03)	213.27 (511.28)
30 min	151.50 (124.64)	163.41 (147.62)
45 min	171.53 (178.85)	172.03 (155.38)
60 min	150.76 (93.06)	215.58 (437.87)
75 min	183.87 (216.89)	255.99 (549.68)

Socio-evaluative Speech Stress Session vs Control Session: Slope: -0.00015, p = 0.86, Mixed Models Analysis

Primary outcome: Interleukin-6

Time frame: 5 minutes before to 5, 10, 20, 30, 45, 60, 75, 90, 120 post-task periods. Mean (Standard Deviation). Unit: pg/ml

Measure	Socio-evaluative Speech Stress Session n = 63	Control Session n = 61
5 mins pre-task	1.52 (1.29)	1.40 (0.99)
5 min	1.76 (1.31)	1.58 (0.94)
10 min	1.61 (1.24)	1.52 (0.94)
20 min	2.05 (1.49)	1.78 (1.01)
30 min	2.01 (1.44)	1.85 (1.29)
45 min	2.30 (1.70)	2.15 (1.32)
60 min	2.50 (1.76)	2.27 (1.34)
75 min	3.28 (3.61)	3.06 (2.84)

Socio-evaluative Speech Stress Session vs Control Session: Slope: 0.00022, p = 0.74, Mixed Models Analysis

Primary outcome: Tumor Necrosis Factor-alpha

Time frame: 5 minutes before to 5, 10, 20, 30, 45, 60, 75, 90, 120 post-task periods. Mean (Standard Deviation). Unit: pg/ml

Measure	Socio-evaluative Speech Stress Session n = 63	Control Session n = 61
5 min pre-task	5.92 (2.21)	6.10 (2.21)
5 min	6.62 (1.90)	6.81 (2.79)
10 min	6.59 (1.84)	6.28 (1.92)
20 min	6.70 (1.72)	6.79 (2.76)
30 min	6.45 (1.82)	6.35 (1.89)
45 min	6.61 (1.76)	6.74 (2.63)
60 min	6.41 (1.65)	6.52 (2.51)
75 min	6.58 (1.68)	6.79 (2.64)

Socio-evaluative Speech Stress Session: Slope: -0.0012, p = 0.52, Mixed Models Analysis

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Socio-evaluative Speech Stress Session	0 of 63 (0%)	0 of 63 (0%)	0 of 63
Control Session	0 of 61 (0%)	0 of 61 (0%)	0 of 61

Limitations and caveats (from the sponsor): The trial was disrupted by the COVID-19 pandemic.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31029929Trumpff 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.
Background: PubMed 31112904Trumpff 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.
Individual participant dataSharing planned: Yes. 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anna L Marsland, Ph.D. principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Socio-evaluative speech task in people with Acute Inflammatory Response to Psychological Stress, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cell-free Mitochondrial DNA (time frame: 5 minutes before task, and 5, 10, 20, 30, 45, 60, 75, 90 and 120 minutes after the task.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04078035, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024; AzTrials last refreshed its copy on 2 Nov 2026.