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临床试验/NCT03458910
NCT03458910终止不适用

Why Does Heart Rate Variability Matter for Emotion Regulation

University of Southern California2 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2018年2月14日最近更新:
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适应症

试验速览

阶段
不适用
状态
终止
入组人数
193
试验地点
2
主要终点
mPFC-right Amygdala Resting-state Functional Connectivity for Younger Adults (ANOVA)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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

结局指标

主要结局

mPFC-right Amygdala Resting-state Functional Connectivity for Younger Adults (ANOVA)

时间窗: Time 1 (Baseline), Time 2 (5 weeks)

The strength of resting-state functional connectivity was measured by correlation coefficients. Values represent the correlation of BOLD time-series between mPFC and the right amygdala. Higher values indicate greater connectivity.

mPFC-right Amygdala Resting-state Functional Connectivity for Older Adults (ANOVA)

时间窗: Time 1 (Baseline), Time 2 (5 weeks)

The strength of resting-state functional connectivity was measured by correlation coefficients. Values represent the correlation of BOLD time-series between mPFC and the right amygdala. Higher values indicate greater connectivity.

mPFC-right Amygdala Resting-state Functional Connectivity for Younger Adults (Post-Pre)

时间窗: Time 1 (Baseline), Time 2 (5 weeks)

The strength of resting-state functional connectivity between mPFC and the right amygdala was measured by correlation coefficients. The difference in functional connectivity between the two time points (Time 2 - Time 1) was calculated. Higher values indicate greater connectivity at Time 2 than Time 1 (or post- than pre-intervention).

mPFC-right Amygdala Resting-state Functional Connectivity for Older Adults (Post-Pre)

时间窗: Time 1 (Baseline), Time 2 (5 weeks)

The strength of resting-state functional connectivity between mPFC and the right amygdala was measured by correlation coefficients. The difference in functional connectivity between the two time points (Time 2 - Time 1) was calculated. Higher values indicate greater connectivity at Time 2 than Time 1 (or post- than pre-intervention).

次要结局

  • Inflammation Measured by IL-6 Levels for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by IL-8 Levels for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by IL-8 Levels for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by TNF-a Levels for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by TNF-a Levels for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Amyloid Beta 40 (Aβ40) for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Amyloid Beta 40 (Aβ40) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Amyloid Beta 42 (Aβ42) Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Amyloid Beta 42 (Aβ42) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Phosphorylated Tau 181 (pTau) for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Phosphorylated Tau 181 (pTau) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Total Tau (tTau) for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Total Tau (tTau) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • mPFC-left Amygdala Resting-state Functional Connectivity for Younger Adults (Post-Pre)(Time 1 (Baseline), Time 2 (5 weeks))
  • mPFC-left Amygdala Resting-state Functional Connectivity for Older Adults (Post-Pre)(Time 1 (Baseline), Time 2 (5 weeks))
  • mPFC-left Amygdala Resting-state Functional Connectivity for Younger Adults (ANOVA)(Time 1 (Baseline), Time 2 (5 weeks))
  • mPFC-left Amygdala Resting-state Functional Connectivity for Older Adults (ANOVA)(Time 1 (Baseline), Time 2 (5 weeks))
  • Low Frequency (LF) HRV for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • The Root Mean Squared Successive Differences (RMSSD) HRV for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • The Root Mean Squared Successive Differences (RMSSD) HRV for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by C-reactive Protein for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by C-reactive Protein for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by IL-1b Levels for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by IL-1b Levels for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by IL-6 Levels for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Emotion Regulation in Younger Adults (Behavior)(Time 1 (Baseline), Time 2 (5 weeks))
  • Emotion Regulation in Older Adults (Behavior)(Time 1 (Baseline), Time 2 (5 weeks))
  • Left Amygdala BOLD Activity During Emotion Regulation in Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Left Amygdala BOLD Activity During Emotion Regulation in Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Right Amygdala BOLD Activity During Emotion Regulation in Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Right Amygdala BOLD Activity During Emotion Regulation in Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Decision-making for Younger Adults at Post Intervention (Behavior)(one time point: at study completion, which is the end of 5-week training)
  • Mood for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Mood for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Decision-making for Younger Adults (fMRI)(one time point: at study completion, which is the end of 5-week training)
  • Depression for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Depression for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • State Anxiety for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • State Anxiety for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Trait Anxiety for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Trait Anxiety for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Stress Recovery (Systolic Blood Pressure) for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Stress Recovery (Systolic Blood Pressure) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Stress Recovery (Heart Rate) for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Stress Recovery (Heart Rate) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Stress Recovery (Breathing Rate) for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Stress Recovery (Breathing Rate) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Stress Reactivity (Systolic Blood Pressure) for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Stress Reactivity (Systolic Blood Pressure) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Stress Reactivity (Heart Rate) for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Stress Reactivity (Heart Rate) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Stress Reactivity (Breathing Rate) for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Stress Reactivity (Breathing Rate) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Arterial Spin Labeling (ASL) for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Arterial Spin Labeling (ASL) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • High Frequency (HF) HRV for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • High Frequency (HF) HRV for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Low Frequency (LF) HRV for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Low Frequency (LF) HRV for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • The Root Mean Squared Successive Differences (RMSSD) HRV for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • The Root Mean Squared Successive Differences (RMSSD) HRV for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by C-reactive Protein for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by C-reactive Protein for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by IL-1b Levels for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by IL-1b Levels for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by IL-6 Levels for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by IL-6 Levels for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by IL-8 Levels for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by IL-8 Levels for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by TNF-a Levels for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Inflammation Measured by TNF-a Levels for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Amyloid Beta 40 (Aβ40) for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Amyloid Beta 40 (Aβ40) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Amyloid Beta 42 (Aβ42) Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Amyloid Beta 42 (Aβ42) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Phosphorylated Tau 181 (pTau) for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Phosphorylated Tau 181 (pTau) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Total Tau (tTau) for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Plasma Total Tau (tTau) for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • LC-innervated Subregion Volume in the Hippocampus for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • LC-innervated Subregion Volume in the Hippocampus for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Cortical Volume in the Left Orbitofrontal Cortex for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Cortical Volume in the Left Orbitofrontal Cortex for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Cortical Volume in the Right Orbitofrontal Cortex for Younger Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • Cortical Volume in the Right Orbitofrontal Cortex for Older Adults(Time 1 (Baseline), Time 2 (5 weeks))
  • mPFC-left Amygdala Resting-state Functional Connectivity for Younger Adults (Post-Pre)(Time 1 (Baseline), Time 2 (5 weeks))
  • mPFC-left Amygdala Resting-state Functional Connectivity for Older Adults (Post-Pre)(Time 1 (Baseline), Time 2 (5 weeks))
  • mPFC-left Amygdala Resting-state Functional Connectivity for Younger Adults (ANOVA)(Time 1 (Baseline), Time 2 (5 weeks))
  • mPFC-left Amygdala Resting-state Functional Connectivity for Older Adults (ANOVA)(Time 1 (Baseline), Time 2 (5 weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mara Mather

Professor of Gerontology and Psychology

University of Southern California

研究点 (2)

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