MedPath

Heart Rate Variability and Emotion Regulation

Not Applicable
Terminated
Conditions
Heart Rate Variability
Interventions
Behavioral: HRV training
Registration Number
NCT03458910
Lead Sponsor
University of Southern California
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
193
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
HRV-decrease groupHRV trainingHalf of the participants will be randomly assigned to this group who will undergo daily practice to decrease their HRV and heart rate.
HRV-increase groupHRV trainingHalf of the participants will be randomly assigned to this group who will undergo daily practice to increase their heart rate variability (HRV).
Primary Outcome Measures
NameTimeMethod
MPFC-amygdala functional connectivitytwo time points: an average of 5 weeks between Time 1 and Time 2

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.

Secondary Outcome Measures
NameTimeMethod
Emotion regulation (behavior)two time points: an average of 5 weeks between Time 1 and Time 2

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.

Emotion regulation (fMRI)two time points: an average of 5 weeks between Time 1 and Time 2

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.

Decision-making (behavior)one time point: at study completion, which is the end of 5-week training

The investigators will examine the difference between groups in decision-making ability measured by multiple-choice responses during a computer-based task.

Emotional well-beingtwo time points: an average of 5 weeks between Time 1 and Time 2

The investigators will examine the difference between Time 1 and Time 2 and between groups in emotional well-being by using standardized questionnaires.

Stress reactivitytwo time points: an average of 5 weeks between Time 1 and Time 2

The investigators will examine the difference between Time 1 and Time 2 and between groups in stress reactivity elicited by standard cognitive tasks.

Decision-making (fMRI)one time point: at study completion, which is the end of 5-week training

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.

Arterial Spin Labeling (ASL)one time point: at study completion, which is the end of 5-week training

The investigators will examine the difference between groups in cerebral blood flow during rest and paced-breathing using ASL technique.

Stress recoverytwo time points: an average of 5 weeks between Time 1 and Time 2

The investigators will examine the difference between Time 1 and Time 2 and between groups in recovery from stress elicited by standard cognitive tasks.

HRVtwo time points: an average of 5 weeks between Time 1 and Time 2

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).

Inflammatory markerstwo time points: an average of 5 weeks between Time 1 and Time 2

The investigators will examine the difference between Time 1 and Time 2 and between groups in inflammatory markers including C-reactive protein and cytokines.

Trial Locations

Locations (1)

University of Southern California

🇺🇸

Los Angeles, California, United States

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