Heart Rate Variability and Emotion Regulation

Heart Rate Variability Clinical Trial

— HRV-ER  

Official title:

Why Does Heart Rate Variability Matter for Emotion Regulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03458910
• Other study ID #: UP-17-00219
• Status: Terminated
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: May 5, 2020

Study information

• Verified date: October 2020
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 193
• Est. completion date: May 5, 2020
• Est. primary completion date: March 13, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Rate Variability

Intervention

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

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Working memory	The investigators will examine the difference between Time 1 and Time 2 and between groups in cognitive performance measured by NIH Toolbox List Sorting Working Memory Test (LSWM).	two time points: an average of 5 weeks between Time 1 and Time 2
Other	Processing Speed	The investigators will examine the difference between Time 1 and Time 2 and between groups in cognitive performance measured by NIH Toolbox Pattern Comparison Processing Speed Test (PCPS).	two time points: an average of 5 weeks between Time 1 and Time 2
Other	Inhibitory Control and Attention	The investigators will examine the difference between Time 1 and Time 2 and between groups in cognitive performance measured by NIH Toolbox Flanker Inhibitory Control and Attention Test (Flanker).	two time points: an average of 5 weeks between Time 1 and Time 2
Other	Sustained attention	The investigators will examine the difference between Time 1 and Time 2 and between groups in cognitive performance measured by Sustained Attention to Response Test (SART).	two time points: an average of 5 weeks between Time 1 and Time 2
Other	Recognition memory	The investigators will examine the difference between groups in recognition memory performance.	one time point: after about three and half weeks of training
Other	Recall	The investigators will examine the difference between groups in recall memory performance.	one time point: after about three and half weeks of training
Other	Stress	The investigators will examine the difference between Time 1 and Time 2 and between groups in stress measured by cortisol levels.	two time points: an average of 5 weeks between Time 1 and Time 2
Primary	MPFC-amygdala functional connectivity	The investigators will compute right amygdala - mPFC functional connectivity values during resting state and fMRI scan for the Time 1 (before HRV biofeedback) and Time 2 (after HRV biofeedback) scans. The investigators will then compute the difference in these functional connectivity values before and after biofeedback (Time 2 - Time 1) for each group.	two time points: an average of 5 weeks between Time 1 and Time 2
Secondary	Emotion regulation (behavior)	The investigators will examine the difference between Time 1 and Time 2 and between groups in emotion regulation ability measured by self-reported effectiveness when instructed to regulate emotion during viewing emotional pictures.	two time points: an average of 5 weeks between Time 1 and Time 2
Secondary	Emotion regulation (fMRI)	The investigators will examine the difference between Time 1 and Time 2 and between groups in the ability to up- and down-regulate amygdala activity when instructed to regulate emotion during viewing emotional pictures.	two time points: an average of 5 weeks between Time 1 and Time 2
Secondary	Decision-making (behavior)	The investigators will examine the difference between groups in decision-making ability measured by multiple-choice responses during a computer-based task.	one time point: at study completion, which is the end of 5-week training
Secondary	Decision-making (fMRI)	The investigators will examine the difference between groups in the ability to up- and down-regulate task-relevant brain regions during a computer-based task.	one time point: at study completion, which is the end of 5-week training
Secondary	Emotional well-being	The investigators will examine the difference between Time 1 and Time 2 and between groups in emotional well-being by using standardized questionnaires.	two time points: an average of 5 weeks between Time 1 and Time 2
Secondary	Stress recovery	The investigators will examine the difference between Time 1 and Time 2 and between groups in recovery from stress elicited by standard cognitive tasks.	two time points: an average of 5 weeks between Time 1 and Time 2
Secondary	Stress reactivity	The investigators will examine the difference between Time 1 and Time 2 and between groups in stress reactivity elicited by standard cognitive tasks.	two time points: an average of 5 weeks between Time 1 and Time 2
Secondary	HRV	The investigators will examine the difference between Time 1 and Time 2 and between groups in HRV measured by high frequency (HF) HRV.	two time points: an average of 5 weeks between Time 1 and Time 2
Secondary	HRV	The investigators will examine the difference between Time 1 and Time 2 and between groups in HRV measured by low frequency (LF) HRV.	two time points: an average of 5 weeks between Time 1 and Time 2
Secondary	HRV	The investigators will examine the difference between Time 1 and Time 2 and between groups in HRV measured by the root mean square of successive differences (RMSSD).	two time points: an average of 5 weeks between Time 1 and Time 2
Secondary	Inflammatory markers	The investigators will examine the difference between Time 1 and Time 2 and between groups in inflammatory markers including C-reactive protein and cytokines.	two time points: an average of 5 weeks between Time 1 and Time 2
Secondary	Arterial Spin Labeling (ASL)	The investigators will examine the difference between groups in cerebral blood flow during rest and paced-breathing using ASL technique.	one time point: at study completion, which is the end of 5-week training