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Heart Rate Variability and Emotion Regulation

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ClinicalTrials.gov Identifier: NCT03458910
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Mara Mather, 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.

Condition or disease Intervention/treatment Phase
Heart Rate Variability Behavioral: HRV training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to either the HRV-increase group or the HRV-decrease group.
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Why Does Heart Rate Variability Matter for Emotion Regulation
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Experimental: 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).
Behavioral: HRV training
Participants will be asked to undergo daily practice to regulate (either increase or decrease) HRV for 5 weeks.

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




Primary Outcome Measures :
  1. MPFC-amygdala functional connectivity [ Time Frame: two 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 :
  1. Emotion regulation (behavior) [ Time Frame: 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.

  2. Emotion regulation (fMRI) [ Time Frame: 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.

  3. Decision-making (behavior) [ Time Frame: 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.

  4. Decision-making (fMRI) [ Time Frame: 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.

  5. Emotional well-being [ Time Frame: 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 emotional well-being by using standardized questionnaires.

  6. Stress recovery [ Time Frame: 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 recovery from stress elicited by standard cognitive tasks.

  7. Stress reactivity [ Time Frame: 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 stress reactivity elicited by standard cognitive tasks.

  8. HRV [ Time Frame: 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 HRV measured by high frequency (HF) HRV.

  9. HRV [ Time Frame: 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 HRV measured by low frequency (LF) HRV.

  10. HRV [ Time Frame: 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 HRV measured by the root mean square of successive differences (RMSSD).

  11. Inflammatory markers [ Time Frame: 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 inflammatory markers including C-reactive protein and cytokines.

  12. Arterial Spin Labeling (ASL) [ Time Frame: 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.


Other Outcome Measures:
  1. Working memory [ Time Frame: 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 cognitive performance measured by NIH Toolbox List Sorting Working Memory Test (LSWM).

  2. Processing Speed [ Time Frame: 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 cognitive performance measured by NIH Toolbox Pattern Comparison Processing Speed Test (PCPS).

  3. Inhibitory Control and Attention [ Time Frame: 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 cognitive performance measured by NIH Toolbox Flanker Inhibitory Control and Attention Test (Flanker).

  4. Sustained attention [ Time Frame: 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 cognitive performance measured by Sustained Attention to Response Test (SART).

  5. Recognition memory [ Time Frame: one time point: after about three and half weeks of training ]
    The investigators will examine the difference between groups in recognition memory performance.

  6. Recall [ Time Frame: one time point: after about three and half weeks of training ]
    The investigators will examine the difference between groups in recall memory performance.

  7. Stress [ Time Frame: 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 stress measured by cortisol levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Fluent in English
  • Aged between 18-35 for the younger group and aged between 55-75 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458910


Contacts
Contact: Kaoru Nashiro, PhD (213) 740-9407 nashiro@usc.edu
Contact: Hyun Joo Yoo, PhD hyunjooy@usc.edu

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90089
Contact: Christine Cho    213-740-9543    cho890@usc.edu   
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Mara Mather, PhD University of Southern California

Responsible Party: Mara Mather, Professor of Gerontology and Psychology, University of Southern California
ClinicalTrials.gov Identifier: NCT03458910     History of Changes
Other Study ID Numbers: UP-17-00219
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mara Mather, University of Southern California:
heart rate variability, HRV