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NCT04078035 · ClinicalTrials.gov registry record · NA
Biological Response to Brief Psychological Challenge
A NA study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- NA
- Development phase
- 72
- Enrollment target
NCT04078035: Completed NA study, sponsored by University of Pittsburgh.
NCT04078035 is a NA study that has completed, run by University of Pittsburgh. The registered enrollment target is 72 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04078035, a NA study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Serum levels of mitochondrial DNA assessed from blood samples
Interventions
- BEHAVIORAL Socio-evaluative speech task
- BEHAVIORAL Control, Quiet Rest
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2020-07-23 |
| Est. Completion | 2022-01-31 |
| Phase | NA |
What the finished NCT04078035 record still lists
NCT04078035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Socio-evaluative speech task is the first listed.
NCT04078035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04078035 about?
NCT04078035 is a clinical study titled "Biological Response to Brief Psychological Challenge". 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 ...
What is the current status of trial NCT04078035?
This trial is currently completed. It is a NA study. The enrollment target is 72 participants. The study started on 2020-07-23. Estimated completion is 2022-01-31.
What interventions are being tested in trial NCT04078035?
The interventions under investigation include: Socio-evaluative speech task (BEHAVIORAL), Control, Quiet Rest (BEHAVIORAL).
Who is sponsoring clinical trial NCT04078035?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04078035's enrollment target sits among peer trials
72 1089th of 2000 higher than 899 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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