Clinical trial NCT03458910: Heart Rate Variability and Emotion Regulation
Official title: Why Does Heart Rate Variability Matter for Emotion Regulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Rate Variability
Keywords: heart rate variability, HRV
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either the HRV-increase group or the HRV-decrease group.
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: mPFC-right Amygdala Resting-state Functional Connectivity for Younger Adults (ANOVA)
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: mPFC-right Amygdala Resting-state Functional Connectivity for Older Adults (ANOVA)
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: mPFC-right Amygdala Resting-state Functional Connectivity for Younger Adults (Post-Pre)
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: mPFC-right Amygdala Resting-state Functional Connectivity for Older Adults (Post-Pre)
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
Secondary outcomes:
measure: Emotion Regulation in Younger Adults (Behavior)
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Emotion Regulation in Older Adults (Behavior)
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Left Amygdala BOLD Activity During Emotion Regulation in Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Left Amygdala BOLD Activity During Emotion Regulation in Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Right Amygdala BOLD Activity During Emotion Regulation in Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Right Amygdala BOLD Activity During Emotion Regulation in Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Decision-making for Younger Adults at Post Intervention (Behavior)
timeFrame: one time point: at study completion, which is the end of 5-week training
measure: Decision-making for Younger Adults (fMRI)
timeFrame: one time point: at study completion, which is the end of 5-week training
measure: Mood for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Mood for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Depression for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Depression for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: State Anxiety for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: State Anxiety for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Trait Anxiety for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Trait Anxiety for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Stress Recovery (Systolic Blood Pressure) for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Stress Recovery (Systolic Blood Pressure) for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Stress Recovery (Heart Rate) for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Stress Recovery (Heart Rate) for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Stress Recovery (Breathing Rate) for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Stress Recovery (Breathing Rate) for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Stress Reactivity (Systolic Blood Pressure) for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Stress Reactivity (Systolic Blood Pressure) for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Stress Reactivity (Heart Rate) for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Stress Reactivity (Heart Rate) for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Stress Reactivity (Breathing Rate) for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Stress Reactivity (Breathing Rate) for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Arterial Spin Labeling (ASL) for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Arterial Spin Labeling (ASL) for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: High Frequency (HF) HRV for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: High Frequency (HF) HRV for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Low Frequency (LF) HRV for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Low Frequency (LF) HRV for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: The Root Mean Squared Successive Differences (RMSSD) HRV for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: The Root Mean Squared Successive Differences (RMSSD) HRV for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Inflammation Measured by C-reactive Protein for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Inflammation Measured by C-reactive Protein for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Inflammation Measured by IL-1b Levels for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Inflammation Measured by IL-1b Levels for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Inflammation Measured by IL-6 Levels for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Inflammation Measured by IL-6 Levels for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Inflammation Measured by IL-8 Levels for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Inflammation Measured by IL-8 Levels for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Inflammation Measured by TNF-a Levels for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Inflammation Measured by TNF-a Levels for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Plasma Amyloid Beta 40 (Aβ40) for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Plasma Amyloid Beta 40 (Aβ40) for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Plasma Amyloid Beta 42 (Aβ42) Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Plasma Amyloid Beta 42 (Aβ42) for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Plasma Phosphorylated Tau 181 (pTau) for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Plasma Phosphorylated Tau 181 (pTau) for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Plasma Total Tau (tTau) for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Plasma Total Tau (tTau) for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: LC-innervated-sub Region Volume in Hippocampus for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: LC-innervated-sub Region Volume in Hippocampus for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Cortical Volume in Left Orbitofrontal Cortex or Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Cortical Volume in Left Orbitofrontal Cortex for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Cortical Volume in Right Orbitofrontal Cortex for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Cortical Volume in Right Orbitofrontal Cortex for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: mPFC-left Amygdala Resting-state Functional Connectivity for Younger Adults (Post-Pre)
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: mPFC-left Amygdala Resting-state Functional Connectivity for Older Adults (Post-Pre)
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: mPFC-left Amygdala Resting-state Functional Connectivity for Younger Adults (ANOVA)
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: mPFC-left Amygdala Resting-state Functional Connectivity for Older Adults (ANOVA)
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
Other outcomes:
measure: Working Memory for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Working Memory for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Processing Speed for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Processing Speed for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Inhibitory Control and Attention for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Inhibitory Control and Attention for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Sustained Attention for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Sustained Attention for Older Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
measure: Recognition Memory for Younger Adults (Hits)
timeFrame: Week 5 Lab Visit (after about 2.5-3 weeks of training)
measure: Recognition Memory for Older Adults (Hits)
timeFrame: Week 5 Lab Visit (after about 2.5-3 weeks of training)
measure: Recognition Memory for Younger Adults (False Alarm)
timeFrame: Week 5 Lab Visit (after about 2.5-3 weeks of training)
measure: Recognition Memory for Older Adults (False Alarm)
timeFrame: Week 5 Lab Visit (after about 2.5-3 weeks of training)
measure: Recall Memory for Younger Adults
timeFrame: Week 5 Lab Visit (after about 2.5-3 weeks of training)
measure: Recall Memory for Older Adults
timeFrame: Week 5 Lab Visit (after about 2.5-3 weeks of training)
measure: Stress Measured by Cortisol Levels for Younger Adults
timeFrame: Time 1 (Baseline), Time 2 (5 weeks)
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Mara Mather, PhD
role: PRINCIPAL_INVESTIGATOR
References: