Heart Rate Variability and Emotion Regulation

NCT03458910 | Terminated Results

• 1 other identifier: UP-17-00219
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Heart Rate Variability

Keywords

heart rate variability, HRV

Outcome Measures

Primary Outcomes (4)

• mPFC-right Amygdala Resting-state Functional Connectivity for Younger Adults (ANOVA)

  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.

  Time 1 (Baseline), Time 2 (5 weeks)

• mPFC-right Amygdala Resting-state Functional Connectivity for Older Adults (ANOVA)

  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.

  Time 1 (Baseline), Time 2 (5 weeks)

• mPFC-right Amygdala Resting-state Functional Connectivity for Younger Adults (Post-Pre)

  The strength of resting-state functional connectivity between mPFC and the right amygdala was measured by correlation coefficients. The difference in functional connectivity between the two time points (Time 2 - Time 1) was calculated. Higher values indicate greater connectivity at Time 2 than Time 1 (or post- than pre-intervention).

  Time 1 (Baseline), Time 2 (5 weeks)

• mPFC-right Amygdala Resting-state Functional Connectivity for Older Adults (Post-Pre)

  The strength of resting-state functional connectivity between mPFC and the right amygdala was measured by correlation coefficients. The difference in functional connectivity between the two time points (Time 2 - Time 1) was calculated. Higher values indicate greater connectivity at Time 2 than Time 1 (or post- than pre-intervention).

  Time 1 (Baseline), Time 2 (5 weeks)

Secondary Outcomes (64)

• Emotion Regulation in Younger Adults (Behavior)

  Time 1 (Baseline), Time 2 (5 weeks)

• Emotion Regulation in Older Adults (Behavior)

  Time 1 (Baseline), Time 2 (5 weeks)

• Left Amygdala BOLD Activity During Emotion Regulation in Younger Adults

  Time 1 (Baseline), Time 2 (5 weeks)

• Left Amygdala BOLD Activity During Emotion Regulation in Older Adults

  Time 1 (Baseline), Time 2 (5 weeks)

• Right Amygdala BOLD Activity During Emotion Regulation in Younger Adults

  Time 1 (Baseline), Time 2 (5 weeks)

Other Outcomes (15)

• Working Memory for Younger Adults

  Time 1 (Baseline), Time 2 (5 weeks)

• Working Memory for Older Adults

  Time 1 (Baseline), Time 2 (5 weeks)

• Processing Speed for Younger Adults

  Time 1 (Baseline), Time 2 (5 weeks)

Study Arms (2)

HRV-increase group

EXPERIMENTAL

Half of the participants will be randomly assigned to this group who will undergo daily practice to increase their heart rate variability (HRV).

Behavioral: HRV training

HRV-decrease group

EXPERIMENTAL

Half of the participants will be randomly assigned to this group who will undergo daily practice to decrease their HRV and heart rate.

Behavioral: HRV training

Interventions

HRV training BEHAVIORAL

Participants will be asked to undergo daily practice to regulate (either increase or decrease) HRV for 5 weeks.

HRV-decrease group; HRV-increase group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in English
• Aged between 18-35 for the younger group and aged between 55-80 for the older group
• Scores on TELE indicate no current dementia
• Normal or corrected-to-normal vision and hearing
• People taking antidepressant, anti-anxiety medication and/or attending psychotherapy only if the treatment had been ongoing and unchanged for at least three months

You may not qualify if:

• Have a disorder that would impede performing the HRV biofeedback procedures (i.e., abnormal cardiac rhythm, heart disease including coronary artery disease, angina, and arrhythmia, cardiac pacemaker, stroke, panic attack, cognitive impairment).
• Current practice of any relaxation, biofeedback, or breathing technique.
• Currently taking any psychoactive drugs other than antidepressants or anti-anxiety medications
• No trips that would lead them to miss any of the weekly meetings
• Currently nursing, pregnant, or intend to become pregnant
• Have metals in their body, as this is a scanning requirement
• Have any conditions listed in the MRI Screening form (see below)
• MRI screening
• Cardiac pacemaker
• Implanted cardiac defibrillator
• Aneurysm clip or brain clip
• Carotid artery vascular clamp
• Neurostimulator
• Insulin or infusion pump
• Spinal fusion stimulator

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

Location

Related Publications (2)

• Min J, Rouanet J, Martini AC, Nashiro K, Yoo HJ, Porat S, Cho C, Wan J, Cole SW, Head E, Nation DA, Thayer JF, Mather M. Modulating heart rate oscillation affects plasma amyloid beta and tau levels in younger and older adults. Sci Rep. 2023 Mar 9;13(1):3967. doi: 10.1038/s41598-023-30167-0.

  PMID: 36894565 DERIVED

• Cho C, Yoo HJ, Min J, Nashiro K, Thayer JF, Lehrer PM, Mather M. Changes in Medial Prefrontal Cortex Mediate Effects of Heart Rate Variability Biofeedback on Positive Emotional Memory Biases. Appl Psychophysiol Biofeedback. 2023 Jun;48(2):135-147. doi: 10.1007/s10484-023-09579-1. Epub 2023 Jan 20.

  PMID: 36658380 DERIVED

Results Point of Contact

• Title: Dr. Mara Mather
• Organization: University of Southern California

mara.mather@usc.edu

(213) 821-1868

Study Officials

• Mara Mather, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gerontology and Psychology

Model Details: Participants will be randomly assigned to either the HRV-increase group or the HRV-decrease group.

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 8, 2018
• Study Start: February 14, 2018
• Primary Completion: March 13, 2020
• Study Completion: May 5, 2020
• Last Updated: July 23, 2025
• Results First Posted: May 20, 2025

Record last verified: 2025-07

Locations

US (1)