Heart Rate VariabilityHRV-ERNCT03458910
Heart Rate Variability and Emotion Regulation
A study testing HRV training in people with Heart Rate Variability, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Rate Variability
- What is being tested?
- HRV training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 5 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 46Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90089
About this study
Official title: Why Does Heart Rate Variability Matter for Emotion Regulation
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:
- 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.
- 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.
- Conditions
- Heart Rate Variability
- Being tested
- HRV training
- Keywords
- heart rate variability, HRV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV trainingBehavioural
Participants will be asked to undergo daily practice to regulate (either increase or decrease) HRV for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| HRV-increase group | Experimental | Half of the participants will be randomly assigned to this group who will undergo daily practice to increase their heart rate variability (HRV). Receives: Behavioral: HRV training |
| HRV-decrease group | Experimental | Half of the participants will be randomly assigned to this group who will undergo daily practice to decrease their HRV and heart rate. Receives: Behavioral: HRV training |
What is being measured
The primary outcome is the main question the study is designed to answer.
mPFC-right Amygdala Resting-state Functional Connectivity for Younger Adults (ANOVA)
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.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
mPFC-right Amygdala Resting-state Functional Connectivity for Older Adults (ANOVA)
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.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
mPFC-right Amygdala Resting-state Functional Connectivity for Younger Adults (Post-Pre)
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).
Measured: Time 1 (Baseline), Time 2 (5 weeks)
mPFC-right Amygdala Resting-state Functional Connectivity for Older Adults (Post-Pre)
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).
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Secondary outcomes (64)
Emotion Regulation in Younger Adults (Behavior)
Emotional intensity ratings, which participants reported during the emotion regulation task inside MRI scanner before and after intervention. The ratings ranged from 1 through 4, and 4 represents strongest intensity.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Emotion Regulation in Older Adults (Behavior)
Emotional intensity ratings, which participants reported during the emotion regulation task inside MRI scanner before and after intervention. The ratings ranged from 1 through 4, and 4 represents strongest intensity.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Left Amygdala BOLD Activity During Emotion Regulation in Younger Adults
We measured percent changes (%) in BOLD activity in the left amygdala region during emotion down-regulation, viewing, and up-regulation before and after intervention. The viewing condition was used as a baseline during the task. The change is represented by %.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Left Amygdala BOLD Activity During Emotion Regulation in Older Adults
We measured percent changes (%) in BOLD activity in the left amygdala region during emotion down-regulation, viewing, and up-regulation before and after intervention. The viewing condition was used as a baseline during the task. The change is represented by %.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Right Amygdala BOLD Activity During Emotion Regulation in Younger Adults
We measured percent changes (%) in BOLD activity in the right amygdala region during emotion down-regulation, viewing, and up-regulation before and after intervention. The viewing condition was used as a baseline during the task. The change is represented by %.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Right Amygdala BOLD Activity During Emotion Regulation in Older Adults
We measured percent changes (%) in BOLD activity in the right amygdala region during emotion down-regulation, viewing, and up-regulation before and after intervention. The viewing condition was used as a baseline during the task. The change is represented by %.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Decision-making for Younger Adults at Post Intervention (Behavior)
The decision-making ability was measured by multiple-choice responses during a computer-based task.
Median percentage of acceptance of unfair offers and fair offers were calculated.
A higher percentage of accepted both unfair and fair offers points toward more rational decision-making and likely better emotion regulation.
This task was administered only at post-intervention (but not pre-intervention).
Measured: one time point: at study completion, which is the end of 5-week training
Decision-making for Younger Adults (fMRI)
We measured percent changes (%) in BOLD activity in the dorsal anterior cingulate cortex and anterior insula during a computer-based decision-making task. Higher values indicate greater activity.
Measured: one time point: at study completion, which is the end of 5-week training
Mood for Younger Adults
Emotional well-being measured by the Profile of Mood States (POMS) for younger adults.
The POMS consists of 40 items that are rated on a 5-point scale ranging from "0=not at all" to "4=extremely. Total Mood Disturbance (TMD) was calculated by summing the totals for the negative items and then subtracting the totals for the positive items. A constant (i.e., 100) was added to the TMD formula in order to eliminate negative scores. Higher scores indicate more negative mood states. The scores range from 56 and 216.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Mood for Older Adults
Emotional well-being measured by the Profile of Mood States (POMS) for older adults.
The POMS consists of 40 items that are rated on a 5-point scale ranging from "0=not at all" to "4=extremely. Total Mood Disturbance (TMD) was calculated by summing the totals for the negative items and then subtracting the totals for the positive items. A constant (i.e., 100) was added to the TMD formula in order to eliminate negative scores. Higher scores indicate more negative mood states. The scores range from 56 and 216.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Depression for Younger Adults
Emotional well-being measured by the Center for Epidemiological Studies Depression Scale (CES-D) for younger adults.
The CES-D consists of 20 items that are rated on a scale of 0 to 3 (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Possible range of scores is 0 to 60, with the higher scores indicating more depressive symptoms.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Depression for Older Adults
Emotional well-being measured by the Center for Epidemiological Studies Depression Scale (CES-D) for older adults.
The CES-D consists of 20 items that are rated on a scale of 0 to 3 (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Possible range of scores is 0 to 60, with the higher scores indicating more depressive symptoms.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
State Anxiety for Younger Adults
Emotional well-being measured by the State Anxiety Inventory (SAI) for younger adults.
The SAI consists of 20 items that are rated on a 4-point scale as follows: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Scores range from 20 to 80, with higher scores indicating greater state anxiety.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
State Anxiety for Older Adults
Emotional well-being measured by the State Anxiety Inventory (SAI) for older adults.
The SAI consists of 20 items that are rated on a 4-point scale as follows: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Scores range from 20 to 80, with higher scores indicating greater state anxiety.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Trait Anxiety for Younger Adults
Emotional well-being measured by the Trait Anxiety Inventory (TAI) for younger adults.
The TAI consists of 20 items that are rated on a 4-point scale as follows: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Scores range from 20 to 80, with higher scores indicating greater trait anxiety.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Trait Anxiety for Older Adults
Emotional well-being measured by the Trait Anxiety Inventory (TAI) for older adults.
The TAI consists of 20 items that are rated on a 4-point scale as follows: 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. Scores range from 20 to 80, with higher scores indicating greater trait anxiety.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Systolic Blood Pressure) for Younger Adults
Difference in stress recovery elicited by standard cognitive tasks, as assessed by change in systolic blood pressure from cognitive tasks to recovery rest
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Systolic Blood Pressure) for Older Adults
Difference in stress recovery elicited by standard cognitive tasks, as assessed by change in systolic blood pressure from cognitive tasks to recovery rest
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Heart Rate) for Younger Adults
Difference in stress recovery elicited by standard cognitive tasks, as assessed by change in heart rate from cognitive tasks to recovery rest
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Heart Rate) for Older Adults
Difference in stress recovery elicited by standard cognitive tasks, as assessed by change in heart rate from cognitive tasks to recovery rest
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Breathing Rate) for Younger Adults
Difference in stress recovery elicited by standard cognitive tasks, as assessed by change in breathing rate from cognitive tasks to recovery rest
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Breathing Rate) for Older Adults
Difference in stress recovery elicited by standard cognitive tasks, as assessed by change in breathing rate from cognitive tasks to recovery rest
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Systolic Blood Pressure) for Younger Adults
Difference in stress reactivity elicited by standard cognitive tasks, as assessed by change in systolic blood pressure from rest to cognitive tasks
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Systolic Blood Pressure) for Older Adults
Difference in stress reactivity elicited by standard cognitive tasks, as assessed by change in systolic blood pressure from rest to cognitive tasks
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Heart Rate) for Younger Adults
Difference in stress reactivity elicited by standard cognitive tasks, as assessed by change in heart rate from rest to cognitive tasks
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Heart Rate) for Older Adults
Difference in stress reactivity elicited by standard cognitive tasks, as assessed by change in heart rate from cognitive tasks to recovery rest
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Breathing Rate) for Younger Adults
Difference in stress reactivity elicited by standard cognitive tasks, as assessed by change in breathing rate from rest to cognitive tasks
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Breathing Rate) for Older Adults
Difference in stress reactivity elicited by standard cognitive tasks, as assessed by change in breathing rate from rest to cognitive tasks
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Arterial Spin Labeling (ASL) for Younger Adults
Cerebral blood flow was measured at pre-training resting state and post-training paced-breathing.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Arterial Spin Labeling (ASL) for Older Adults
Cerebral blood flow was measured at pre-training resting state and post-training paced-breathing.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
High Frequency (HF) HRV for Younger Adults
HRV measured by high frequency (HF) HRV for younger adults.
HF-HRV was quantified as the spectral power of interbeat interval variability within the high frequency range (typically 0.15-0.40 Hz), which reflects parasympathetic (vagal) activity. In this study, HF-HRV was obtained using photoplethysmography (PPG) methods. During a standardized resting condition, the device continuously recorded interbeat intervals. These data were then processed via spectral analysis to calculate the power in the high frequency band. Measurements are expressed in units of milliseconds squared (ms²). Higher HF-HRV values indicate increased parasympathetic modulation and are generally associated with improved autonomic regulation and better cognitive performance.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
High Frequency (HF) HRV for Older Adults
HRV measured by high frequency (HF) HRV for older adults.
HF-HRV was quantified as the spectral power of interbeat interval variability within the high frequency range (typically 0.15-0.40 Hz), which reflects parasympathetic (vagal) activity. In this study, HF-HRV was obtained using photoplethysmography (PPG) methods. During a standardized resting condition, the device continuously recorded interbeat intervals. These data were then processed via spectral analysis to calculate the power in the high frequency band. Measurements are expressed in units of milliseconds squared (ms²). Higher HF-HRV values indicate increased parasympathetic modulation and are generally associated with improved autonomic regulation and better cognitive performance.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Low Frequency (LF) HRV for Younger Adults
HRV measured by low frequency (LF) HRV for younger adults.
LF-HRV was quantified as the spectral power of interbeat interval variability within the low frequency range (typically 0.04-0.15 Hz), which reflects the combined influences of sympathetic and parasympathetic activity. In this study, LF-HRV was obtained using photoplethysmography (PPG) methods. During a standardized resting condition, the device continuously recorded interbeat intervals. These data were then processed via spectral analysis to calculate the power in the low frequency band. Measurements are expressed in units of milliseconds squared (ms²). Although LF-HRV reflects contributions from both branches of the autonomic nervous system, higher LF-HRV values can indicate enhanced autonomic modulation, with interpretation made in the context of overall autonomic balance.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Low Frequency (LF) HRV for Older Adults
HRV measured by low frequency (LF) HRV for older adults.
LF-HRV was quantified as the spectral power of interbeat interval variability within the low frequency range (typically 0.04-0.15 Hz), which reflects the combined influences of sympathetic and parasympathetic activity. In this study, LF-HRV was obtained using photoplethysmography (PPG) methods. During a standardized resting condition, the device continuously recorded interbeat intervals. These data were then processed via spectral analysis to calculate the power in the low frequency band. Measurements are expressed in units of milliseconds squared (ms²). Although LF-HRV reflects contributions from both branches of the autonomic nervous system, higher LF-HRV values can indicate enhanced autonomic modulation, with interpretation made in the context of overall autonomic balance.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
The Root Mean Squared Successive Differences (RMSSD) HRV for Younger Adults
HRV measured by the root mean square of successive differences (RMSSD) for younger adults.
RMSSD (Root Mean Square of Successive Differences) is a time-domain measure that quantifies the variability between successive interbeat intervals, primarily reflecting parasympathetic (vagal) activity. In this study, RMSSD was obtained using photoplethysmography (PPG) methods. During a standardized resting condition, the device continuously recorded interbeat intervals, and RMSSD was computed as the square root of the mean of the squared differences between consecutive interbeat intervals. Measurements are expressed in milliseconds (ms). Higher RMSSD values indicate increased parasympathetic modulation, generally associated with improved autonomic regulation and better cardiovascular and cognitive performance.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
The Root Mean Squared Successive Differences (RMSSD) HRV for Older Adults
HRV measured by the root mean square of successive differences (RMSSD) for older adults.
RMSSD (Root Mean Square of Successive Differences) is a time-domain measure that quantifies the variability between successive interbeat intervals, primarily reflecting parasympathetic (vagal) activity. In this study, RMSSD was obtained using photoplethysmography (PPG) methods. During a standardized resting condition, the device continuously recorded interbeat intervals, and RMSSD was computed as the square root of the mean of the squared differences between consecutive interbeat intervals. Measurements are expressed in milliseconds (ms). Higher RMSSD values indicate increased parasympathetic modulation, generally associated with improved autonomic regulation and better cardiovascular and cognitive performance.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by C-reactive Protein for Younger Adults
Inflammation measured by salivary C-reactive protein (CRP) for younger adults
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by C-reactive Protein for Older Adults
Inflammation measured by salivary C-reactive protein (CRP) for older adults
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by IL-1b Levels for Younger Adults
Inflammation measured by salivary IL-1b levels for younger adults
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by IL-1b Levels for Older Adults
Inflammation measured by salivary IL-1b levels for older adults
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by IL-6 Levels for Younger Adults
Inflammation measured by salivary IL-6 levels for younger adults
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by IL-6 Levels for Older Adults
Inflammation measured by salivary IL-6 levels for older adults
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by IL-8 Levels for Younger Adults
Inflammation measured by salivary IL-8 levels for younger adults
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by IL-8 Levels for Older Adults
Inflammation measured by salivary IL-8 levels for older adults
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by TNF-a Levels for Younger Adults
Inflammation measured by salivary TNF-a levels for younger adults
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by TNF-a Levels for Older Adults
Inflammation measured by salivary TNF-a levels for older adults
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Plasma Amyloid Beta 40 (Aβ40) for Younger Adults
Plasma Aβ40 levels at pre- and post-intervention were compared between HRV-increase and HRV-decrease group for younger adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Plasma Amyloid Beta 40 (Aβ40) for Older Adults
Plasma Aβ40 levels at pre- and post-intervention were compared between HRV-increase and HRV-decrease group for older adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Plasma Amyloid Beta 42 (Aβ42) Younger Adults
Plasma Aβ42 levels at pre- and post-intervention were compared between HRV-increase and HRV-decrease group for younger adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Plasma Amyloid Beta 42 (Aβ42) for Older Adults
Plasma Aβ42 levels at pre- and post-intervention were compared between HRV-increase and HRV-decrease group for older adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Plasma Phosphorylated Tau 181 (pTau) for Younger Adults
Plasma pTau levels at pre- and post-intervention were reported for HRV-increase and HRV-decrease group for younger adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Plasma Phosphorylated Tau 181 (pTau) for Older Adults
Plasma pTau levels at pre- and post-intervention were compared between HRV-increase and HRV-decrease group for older adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Plasma Total Tau (tTau) for Younger Adults
Plasma tTau levels at pre- and post-intervention were reported for HRV-increase and HRV-decrease group for younger adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Plasma Total Tau (tTau) for Older Adults
Plasma tTau levels at pre- and post-intervention were compared between HRV-increase and HRV-decrease group for older adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
LC-innervated Subregion Volume in the Hippocampus for Younger Adults
LC-innervated subregion volume in the hippocampus at pre- and post-intervention was compared between the HRV-increase and HRV-decrease groups in younger adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
LC-innervated Subregion Volume in the Hippocampus for Older Adults
LC-innervated subregion volume in the hippocampus at pre- and post-intervention was compared between the HRV-increase and HRV-decrease groups in older adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Cortical Volume in the Left Orbitofrontal Cortex for Younger Adults
Left orbitofrontal volume at pre- and post-intervention was compared between the HRV-increase and HRV-decrease groups in younger adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Cortical Volume in the Left Orbitofrontal Cortex for Older Adults
Left orbitofrontal volume at pre- and post-intervention was compared between the HRV-increase and HRV-decrease groups in older adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Cortical Volume in the Right Orbitofrontal Cortex for Younger Adults
Right orbitofrontal volume at pre- and post-intervention was compared between the HRV-increase and HRV-decrease groups in younger adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Cortical Volume in the Right Orbitofrontal Cortex for Older Adults
Right orbitofrontal volume at pre- and post-intervention was compared between the HRV-increase and HRV-decrease groups in older adults.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
mPFC-left Amygdala Resting-state Functional Connectivity for Younger Adults (Post-Pre)
The strength of resting-state functional connectivity between mPFC and the left 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).
Measured: Time 1 (Baseline), Time 2 (5 weeks)
mPFC-left Amygdala Resting-state Functional Connectivity for Older Adults (Post-Pre)
The strength of resting-state functional connectivity between mPFC and the left 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).
Measured: Time 1 (Baseline), Time 2 (5 weeks)
mPFC-left Amygdala Resting-state Functional Connectivity for Younger Adults (ANOVA)
The strength of resting-state functional connectivity was measured by correlation coefficients. Values represent the correlation of BOLD time-series between mPFC and the left amygdala. Higher values indicate greater connectivity.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
mPFC-left Amygdala Resting-state Functional Connectivity for Older Adults (ANOVA)
The strength of resting-state functional connectivity was measured by correlation coefficients. Values represent the correlation of BOLD time-series between mPFC and the left amygdala. Higher values indicate greater connectivity.
Measured: Time 1 (Baseline), Time 2 (5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start14 Feb 2018
- Primary completion13 Mar 2020
- Study completion5 May 2020
Why it stopped: COVID-19 increased risk of participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the HRV-increase group or the HRV-decrease group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mara Mather, University of Southern California
- Investigators
- Mara Mather, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03458910
- Sponsor's protocol ID
- UP-17-00219
- Acronym
- HRV-ER
- Status last verified
- Jul 2025
- First submitted
- 13 Feb 2018
- Last updated
- 23 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Min J, Rouanet J, Martini AC, Nashiro K, Yoo HJ, Porat S, Cho C, Wan J, Cole SW, Head E, Nation DA, Thayer JF, Mather M. Modulating heart rate oscillation affects plasma amyloid beta and tau levels in younger and older adults. Sci Rep. 2023 Mar 9;13(1):3967. doi: 10.1038/s41598-023-30167-0.
PubMed 36894565Cho C, Yoo HJ, Min J, Nashiro K, Thayer JF, Lehrer PM, Mather M. Changes in Medial Prefrontal Cortex Mediate Effects of Heart Rate Variability Biofeedback on Positive Emotional Memory Biases. Appl Psychophysiol Biofeedback. 2023 Jun;48(2):135-147. doi: 10.1007/s10484-023-09579-1. Epub 2023 Jan 20.
PubMed 36658380Min J, Nashiro K, Yoo HJ, Cho C, Nasseri P, Bachman SL, Porat S, Thayer JF, Chang C, Lee TH, Mather M. Emotion Downregulation Targets Interoceptive Brain Regions While Emotion Upregulation Targets Other Affective Brain Regions. J Neurosci. 2022 Apr 6;42(14):2973-2985. doi: 10.1523/JNEUROSCI.1865-21.2022. Epub 2022 Feb 22.
PubMed 35193926
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Why Does Heart Rate Variability Matter for Emotion Regulation
- ClinicalTrials.gov ID
- NCT03458910
- Acronym / sponsor ID
- HRV-ER / UP-17-00219
- Conditions
- Heart Rate Variability
- Keywords
- heart rate variability, HRV
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 increased risk of participation
- Enrolment
- 193 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 8 Mar 2018 (actual)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the HRV-increase group or the HRV-decrease group.
| Arm | Type | Receives |
|---|---|---|
| HRV-increase group | Experimental | Behavioral: HRV trainingHalf of the participants will be randomly assigned to this group who will undergo daily practice to increase their heart rate variability (HRV). |
| HRV-decrease group | Experimental | Behavioral: HRV trainingHalf of the participants will be randomly assigned to this group who will undergo daily practice to decrease their HRV and heart rate. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (46 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRV trainingParticipants will be asked to undergo daily practice to regulate (either increase or decrease) HRV for 5 weeks. | Behavioural | HRV-decrease group, HRV-increase group |
Primary outcome
mPFC-right Amygdala Resting-state Functional Connectivity for Younger Adults (ANOVA)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
64 secondary outcomes
Emotion Regulation in Younger Adults (Behavior)
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Emotion Regulation in Older Adults (Behavior)
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Left Amygdala BOLD Activity During Emotion Regulation in Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Left Amygdala BOLD Activity During Emotion Regulation in Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Right Amygdala BOLD Activity During Emotion Regulation in Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Right Amygdala BOLD Activity During Emotion Regulation in Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Decision-making for Younger Adults at Post Intervention (Behavior)
Time frame: one time point: at study completion, which is the end of 5-week training
Decision-making for Younger Adults (fMRI)
Time frame: one time point: at study completion, which is the end of 5-week training
Mood for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Mood for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Depression for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Depression for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
State Anxiety for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
State Anxiety for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Trait Anxiety for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Trait Anxiety for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Systolic Blood Pressure) for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Systolic Blood Pressure) for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Heart Rate) for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Heart Rate) for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Breathing Rate) for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Breathing Rate) for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Systolic Blood Pressure) for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Systolic Blood Pressure) for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Heart Rate) for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Heart Rate) for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Breathing Rate) for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Breathing Rate) for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Arterial Spin Labeling (ASL) for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Arterial Spin Labeling (ASL) for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
High Frequency (HF) HRV for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
High Frequency (HF) HRV for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Low Frequency (LF) HRV for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Low Frequency (LF) HRV for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
The Root Mean Squared Successive Differences (RMSSD) HRV for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
The Root Mean Squared Successive Differences (RMSSD) HRV for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by C-reactive Protein for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by C-reactive Protein for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by IL-1b Levels for Younger Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by IL-1b Levels for Older Adults
Time frame: Time 1 (Baseline), Time 2 (5 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36894565Min J, Rouanet J, Martini AC, Nashiro K, Yoo HJ, Porat S, Cho C, Wan J, Cole SW, Head E, Nation DA, Thayer JF, Mather M. Modulating heart rate oscillation affects plasma amyloid beta and tau levels in younger and older adults. Sci Rep. 2023 Mar 9;13(1):3967. doi: 10.1038/s41598-023-30167-0.
- Derived from this study: PubMed 36658380Cho C, Yoo HJ, Min J, Nashiro K, Thayer JF, Lehrer PM, Mather M. Changes in Medial Prefrontal Cortex Mediate Effects of Heart Rate Variability Biofeedback on Positive Emotional Memory Biases. Appl Psychophysiol Biofeedback. 2023 Jun;48(2):135-147. doi: 10.1007/s10484-023-09579-1. Epub 2023 Jan 20.
- Derived from this study: PubMed 35193926Min J, Nashiro K, Yoo HJ, Cho C, Nasseri P, Bachman SL, Porat S, Thayer JF, Chang C, Lee TH, Mather M. Emotion Downregulation Targets Interoceptive Brain Regions While Emotion Upregulation Targets Other Affective Brain Regions. J Neurosci. 2022 Apr 6;42(14):2973-2985. doi: 10.1523/JNEUROSCI.1865-21.2022. Epub 2022 Feb 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mara Mather, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRV training in people with Heart Rate Variability, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mPFC-right Amygdala Resting-state Functional Connectivity for Younger Adults (ANOVA) (time frame: Time 1 (Baseline), Time 2 (5 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03458910, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.