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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: Clinical Trial NA study, sponsored by University of Southern California.
NCT03458910 is a NA study that was terminated before completion, run by University of Southern California. The registered enrollment target is 193 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The strength of resting-state functional connectivity was measured by correlation coefficients. Values represent the correlation of BOLD time-series between mPFC and the right amygdala. Higher values indicate greater connectivity.
Interventions
- BEHAVIORAL HRV training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2018-02-14 |
| Est. Completion | 2020-05-05 |
| Phase | NA |
Why NCT03458910 stopped before completion
NCT03458910 is an interventional study that assigns participants to a tested intervention. The registered 193 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which HRV training is the first listed.
NCT03458910 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03458910's enrollment target sits among peer trials
193 569th of 2000 higher than 1,431 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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