Heart Rate Variability and Emotion Regulation

NCT ID: NCT03458910

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 193 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-14
• Study Completion Date: 2020-05-05

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. 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.

Conditions

Heart Rate Variability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

HRV-increase group

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

Group Type: EXPERIMENTAL

HRV training

Intervention Type: BEHAVIORAL

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

HRV-decrease group

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

Group Type: EXPERIMENTAL

HRV training

Intervention Type: BEHAVIORAL

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

Interventions

HRV training

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Cochlear, otologic, ear tubes or ear implant
• Prosthesis (eye/orbital, penile, etc.)
• Implant held in place by a magnet
• Heart valve prosthesis
• Artificial limb or joint
• Other implants in body or head
• Electrodes (on body, head or brain)
• Intravascular stents, filters, or
• Shunt (spinal or intraventricular)
• Vascular access port or catheters
• IUD or diaphragm
• Transdermal delivery system or other types of foil
• patches (e.g. Nitro, Nicotine, Birth control, etc.)
• Shrapnel, buckshot, or bullets
• Tattooed eyeliner or eyebrows
• Body piercing(s)
• Metal fragments (eye, head, ear, skin)
• Internal pacing wires
• Aortic clips
• Metal or wire mesh implants
• Wire sutures or surgical staples
• Harrington rods (spine)
• Bone/joint pin, screw, nail, wire, plate
• Wig, toupee, or hair implants
• Asthma or breathing disorders
• Seizures or motion disorders
• Hospitalization for mental or neurological illness
• Head Trauma
• Migraine Headache
• Panic attack
• Stroke

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Mara Mather

Professor of Gerontology and Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mara Mather, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36894565 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36658380 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

UP-17-00219

Identifier Type: -

Identifier Source: org_study_id