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NCT03458910 · ClinicalTrials.gov registry record · NA

Heart Rate Variability and Emotion Regulation

A NA study, sponsored by University of Southern California.

Terminated
Registry status
NA
Development phase
193
Enrollment target

NCT03458910 is a NA study that was terminated before completion, run by University of Southern California. The registered enrollment target is 193 participants.

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The verdict

NCT03458910, a NA study, was terminated before completion, sponsored by University of Southern California.

TERMINATED
Registry status
NA
Development phase
193 participants
Enrollment target

Study Summary

Previous research suggests that heart rate variability (HRV) biofeedback aimed at increasing HRV can reduce anxiety and stress. However, some mental quiescence practices that reduce HRV during the practice sessions also lead to positive emotional outcomes. Thus, it is not obvious that the benefits of HRV-biofeedback accrue due to increasing HRV during the session. An alternative possibility is that the benefits arise from engaging prefrontal control over heart rate. In this study, the investigators will test two possible mechanisms of the effects of HRV on emotional health by comparing two groups. In one group, participants will be asked to engage in daily training to decrease HRV using the HRV biofeedback device. In the other group, participants will be asked to engage in daily training to increase HRV using the HRV biofeedback device. This will allow analyses to pit two possible mechanisms against each other: 1. Mechanism 1: engaging prefrontal control over heart rate is the critical factor that allows HRV biofeedback to help improve well-being. In this case, well-being should increase over time in both groups, as both training should engage prefrontal cortex to implement self-directed control over heart rate. Strengthening prefrontal control mechanisms may help improve emotion regulation in everyday life. 2. Mechanism 2: increased HRV during the training sessions leads to greater functional connectivity among brain regions associated with emotion regulation during the high HRV state. In this case, improved well-being would be specifically associated with having time each day during which there were very high HRV states, and so improved well-being should be seen only in the group in which participants get biofeedback to increase HRV.

Interventions

  • BEHAVIORAL HRV training

Trial Details

FieldValue
Enrollment Target 193 participants
Start Date 2018-02-14
Est. Completion 2020-05-05
Phase NA

Sponsor

University of Southern California

617 total trials

What the Registry Record Tells You About NCT03458910

The ClinicalTrials.gov registry entry for NCT03458910 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 193 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which HRV training is the first listed.

NCT03458910 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03458910 about?

NCT03458910 is a clinical study titled "Heart Rate Variability and Emotion Regulation". Previous research suggests that heart rate variability (HRV) biofeedback aimed at increasing HRV can reduce anxiety and stress. However, some mental quiescence practices that reduce HRV during the practice sessions also lead to positive emotional outcomes. Thus, it is not obvious that the benefits o...

What is the current status of trial NCT03458910?

This trial is currently terminated. It is a NA study. The enrollment target is 193 participants. The study started on 2018-02-14. Estimated completion is 2020-05-05.

What interventions are being tested in trial NCT03458910?

The interventions under investigation include: HRV training (BEHAVIORAL).

Who is sponsoring clinical trial NCT03458910?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.