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Heart Rate Variability and Emotion Regulation (HRV-ER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03458910
Recruitment Status : Terminated (COVID-19 increased risk of participation)
First Posted : March 8, 2018
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Mara Mather, University of Southern California

Tracking Information
First Submitted Date  ICMJE February 13, 2018
First Posted Date  ICMJE March 8, 2018
Last Update Posted Date October 23, 2020
Actual Study Start Date  ICMJE February 14, 2018
Actual Primary Completion Date March 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 1, 2018)
  • 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).
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Heart Rate Variability and Emotion Regulation
Official Title  ICMJE Why Does Heart Rate Variability Matter for Emotion Regulation
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Heart Rate Variability
Intervention  ICMJE Behavioral: HRV training
Participants will be asked to undergo daily practice to regulate (either increase or decrease) HRV for 5 weeks.
Study Arms  ICMJE
  • 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).
    Intervention: Behavioral: HRV training
  • 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.
    Intervention: Behavioral: HRV training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 21, 2020)
193
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2018)
208
Actual Study Completion Date  ICMJE May 5, 2020
Actual Primary Completion Date March 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03458910
Other Study ID Numbers  ICMJE UP-17-00219
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mara Mather, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mara Mather, PhD University of Southern California
PRS Account University of Southern California
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP