Heart Rate Variability and Emotion Regulation (HRV-ER)

July 11, 2025 updated by: Mara Mather, University of Southern California

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:

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
193

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Time 1 (Baseline), Time 2 (5 weeks)
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.
Time 1 (Baseline), Time 2 (5 weeks)
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).
Time 1 (Baseline), Time 2 (5 weeks)
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).
Time 1 (Baseline), Time 2 (5 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Emotion Regulation in Younger Adults (Behavior)
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
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.
Time 1 (Baseline), Time 2 (5 weeks)
Emotion Regulation in Older Adults (Behavior)
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
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.
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)
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 %.
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)
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 %.
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)
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 %.
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)
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 %.
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

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).
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
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.
one time point: at study completion, which is the end of 5-week training
Depression for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

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.
Time 1 (Baseline), Time 2 (5 weeks)
Depression for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

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.
Time 1 (Baseline), Time 2 (5 weeks)
State Anxiety for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

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.
Time 1 (Baseline), Time 2 (5 weeks)
State Anxiety for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

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.
Time 1 (Baseline), Time 2 (5 weeks)
Trait Anxiety for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

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.
Time 1 (Baseline), Time 2 (5 weeks)
Trait Anxiety for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

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.
Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Systolic Blood Pressure) for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Difference in stress recovery elicited by standard cognitive tasks, as assessed by change in systolic blood pressure from cognitive tasks to recovery rest
Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Systolic Blood Pressure) for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Difference in stress recovery elicited by standard cognitive tasks, as assessed by change in systolic blood pressure from cognitive tasks to recovery rest
Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Heart Rate) for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Difference in stress recovery elicited by standard cognitive tasks, as assessed by change in heart rate from cognitive tasks to recovery rest
Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Heart Rate) for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Difference in stress recovery elicited by standard cognitive tasks, as assessed by change in heart rate from cognitive tasks to recovery rest
Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Breathing Rate) for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Difference in stress recovery elicited by standard cognitive tasks, as assessed by change in breathing rate from cognitive tasks to recovery rest
Time 1 (Baseline), Time 2 (5 weeks)
Stress Recovery (Breathing Rate) for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Difference in stress recovery elicited by standard cognitive tasks, as assessed by change in breathing rate from cognitive tasks to recovery rest
Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Systolic Blood Pressure) for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Difference in stress reactivity elicited by standard cognitive tasks, as assessed by change in systolic blood pressure from rest to cognitive tasks
Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Systolic Blood Pressure) for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Difference in stress reactivity elicited by standard cognitive tasks, as assessed by change in systolic blood pressure from rest to cognitive tasks
Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Heart Rate) for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Difference in stress reactivity elicited by standard cognitive tasks, as assessed by change in heart rate from rest to cognitive tasks
Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Heart Rate) for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Difference in stress reactivity elicited by standard cognitive tasks, as assessed by change in heart rate from cognitive tasks to recovery rest
Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Breathing Rate) for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Difference in stress reactivity elicited by standard cognitive tasks, as assessed by change in breathing rate from rest to cognitive tasks
Time 1 (Baseline), Time 2 (5 weeks)
Stress Reactivity (Breathing Rate) for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Difference in stress reactivity elicited by standard cognitive tasks, as assessed by change in breathing rate from rest to cognitive tasks
Time 1 (Baseline), Time 2 (5 weeks)
Arterial Spin Labeling (ASL) for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Cerebral blood flow was measured at pre-training resting state and post-training paced-breathing.
Time 1 (Baseline), Time 2 (5 weeks)
Arterial Spin Labeling (ASL) for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Cerebral blood flow was measured at pre-training resting state and post-training paced-breathing.
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 salivary C-reactive protein (CRP) for younger adults
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 salivary C-reactive protein (CRP) for older adults
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 salivary IL-1b levels for younger adults
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)
Inflammation measured by salivary IL-1b levels for older adults
Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by IL-6 Levels for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation measured by salivary IL-6 levels for younger adults
Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by IL-6 Levels for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation measured by salivary IL-6 levels for older adults
Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by IL-8 Levels for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation measured by salivary IL-8 levels for younger adults
Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by IL-8 Levels for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation measured by salivary IL-8 levels for older adults
Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by TNF-a Levels for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation measured by salivary TNF-a levels for younger adults
Time 1 (Baseline), Time 2 (5 weeks)
Inflammation Measured by TNF-a Levels for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Inflammation measured by salivary TNF-a levels for older adults
Time 1 (Baseline), Time 2 (5 weeks)
mPFC-left 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 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).
Time 1 (Baseline), Time 2 (5 weeks)
mPFC-left 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 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).
Time 1 (Baseline), Time 2 (5 weeks)
mPFC-left 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 left amygdala. Higher values indicate greater connectivity.
Time 1 (Baseline), Time 2 (5 weeks)
mPFC-left 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 left amygdala. Higher values indicate greater connectivity.
Time 1 (Baseline), Time 2 (5 weeks)
Mood for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

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.
Time 1 (Baseline), Time 2 (5 weeks)
Mood for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

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.
Time 1 (Baseline), Time 2 (5 weeks)
High Frequency (HF) HRV for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

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.
Time 1 (Baseline), Time 2 (5 weeks)
High Frequency (HF) HRV for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

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.
Time 1 (Baseline), Time 2 (5 weeks)
Low Frequency (LF) HRV for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

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.
Time 1 (Baseline), Time 2 (5 weeks)
Low Frequency (LF) HRV for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

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.
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)

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.
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)

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.
Time 1 (Baseline), Time 2 (5 weeks)
Plasma Amyloid Beta 40 (Aβ40) for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Plasma Aβ40 levels at pre- and post-intervention were compared between HRV-increase and HRV-decrease group for younger adults.
Time 1 (Baseline), Time 2 (5 weeks)
Plasma Amyloid Beta 40 (Aβ40) for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Plasma Aβ40 levels at pre- and post-intervention were compared between HRV-increase and HRV-decrease group for older adults.
Time 1 (Baseline), Time 2 (5 weeks)
Plasma Amyloid Beta 42 (Aβ42) Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Plasma Aβ42 levels at pre- and post-intervention were compared between HRV-increase and HRV-decrease group for younger adults.
Time 1 (Baseline), Time 2 (5 weeks)
Plasma Amyloid Beta 42 (Aβ42) for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Plasma Aβ42 levels at pre- and post-intervention were compared between HRV-increase and HRV-decrease group for older adults.
Time 1 (Baseline), Time 2 (5 weeks)
Plasma Phosphorylated Tau 181 (pTau) for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Plasma pTau levels at pre- and post-intervention were reported for HRV-increase and HRV-decrease group for younger adults.
Time 1 (Baseline), Time 2 (5 weeks)
Plasma Phosphorylated Tau 181 (pTau) for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Plasma pTau levels at pre- and post-intervention were compared between HRV-increase and HRV-decrease group for older adults.
Time 1 (Baseline), Time 2 (5 weeks)
Plasma Total Tau (tTau) for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Plasma tTau levels at pre- and post-intervention were reported for HRV-increase and HRV-decrease group for younger adults.
Time 1 (Baseline), Time 2 (5 weeks)
Plasma Total Tau (tTau) for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Plasma tTau levels at pre- and post-intervention were compared between HRV-increase and HRV-decrease group for older adults.
Time 1 (Baseline), Time 2 (5 weeks)
LC-innervated Subregion Volume in the Hippocampus for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
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.
Time 1 (Baseline), Time 2 (5 weeks)
LC-innervated Subregion Volume in the Hippocampus for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
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.
Time 1 (Baseline), Time 2 (5 weeks)
Cortical Volume in the Left Orbitofrontal Cortex for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Left orbitofrontal volume at pre- and post-intervention was compared between the HRV-increase and HRV-decrease groups in younger adults.
Time 1 (Baseline), Time 2 (5 weeks)
Cortical Volume in the Left Orbitofrontal Cortex for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Left orbitofrontal volume at pre- and post-intervention was compared between the HRV-increase and HRV-decrease groups in older adults.
Time 1 (Baseline), Time 2 (5 weeks)
Cortical Volume in the Right Orbitofrontal Cortex for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Right orbitofrontal volume at pre- and post-intervention was compared between the HRV-increase and HRV-decrease groups in younger adults.
Time 1 (Baseline), Time 2 (5 weeks)
Cortical Volume in the Right Orbitofrontal Cortex for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Right orbitofrontal volume at pre- and post-intervention was compared between the HRV-increase and HRV-decrease groups in older adults.
Time 1 (Baseline), Time 2 (5 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Working Memory for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Working memory performance measured by NIH Toolbox List Sorting Working Memory Test (LSWM). The standard score is calculated to have a normative mean of 100 and a standard deviation (SD) of 15. Scores range from 59 to 140, with higher scores indicating better Working memory.
Time 1 (Baseline), Time 2 (5 weeks)
Working Memory for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

Working memory performance measured by NIH Toolbox List Sorting Working Memory Test (LSWM).

The standard score is calculated to have a normative mean of 100 and a standard deviation (SD) of 15. Scores range from 59 to 140, with higher scores indicating better Working memory.
Time 1 (Baseline), Time 2 (5 weeks)
Processing Speed for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

Processing speed performance measured by NIH Toolbox Pattern Comparison Processing Speed Test (PCPS).

The standard score is calculated to have a normative mean of 100 and a standard deviation (SD) of 15. Scores range from 59 to 140, with higher scores indicating faster processing speed.
Time 1 (Baseline), Time 2 (5 weeks)
Processing Speed for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

Processing speed performance measured by NIH Toolbox Pattern Comparison Processing Speed Test (PCPS).

The standard score is calculated to have a normative mean of 100 and a standard deviation (SD) of 15. Scores range from 59 to 140, with higher scores indicating faster processing speed.
Time 1 (Baseline), Time 2 (5 weeks)
Inhibitory Control and Attention for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

Inhibitory control performance measured by NIH Toolbox Flanker Inhibitory Control and Attention Test (Flanker).

The standard score is calculated to have a normative mean of 100 and a standard deviation (SD) of 15. Scores range from 59 to 140, with higher scores indicating better Inhibitory Control and Attention.
Time 1 (Baseline), Time 2 (5 weeks)
Inhibitory Control and Attention for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

Inhibitory control performance measured by NIH Toolbox Flanker Inhibitory Control and Attention Test (Flanker).

The standard score is calculated to have a normative mean of 100 and a standard deviation (SD) of 15. Scores range from 59 to 140, with higher scores indicating better Inhibitory Control and Attention.
Time 1 (Baseline), Time 2 (5 weeks)
Sustained Attention for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

Sustained attention performance was measured by Sustained Attention to Response Test (SART).

A commission error was calculated as the number of button press for 25 no-go trials, and an omission error was calculated as the number of no button press for 200 go trials in younger adults. The number of errors range from 0 to 25 for commission errors and from 0 to 200 for omission errors. A higher number of omission and commission errors indicates worse sustained attention performance.
Time 1 (Baseline), Time 2 (5 weeks)
Sustained Attention for Older Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)

Sustained attention performance was measured by Sustained Attention to Response Test (SART).

A commission error was calculated as the number of button press for 25 no-go trials, and an omission error was calculated as the number of no button press for 200 go trials in older adults. The number of errors range from 0 to 25 for commission errors and from 0 to 200 for omission errors. A higher number of omission and commission errors indicates worse sustained attention performance.
Time 1 (Baseline), Time 2 (5 weeks)
Recognition Memory for Younger Adults (Hits)
Time Frame: Week 5 Lab Visit (after about 2.5-3 weeks of training)
Recognition memory performance based on average proportion of previously presented images that were correctly identified (i.e., hits) by younger adults
Week 5 Lab Visit (after about 2.5-3 weeks of training)
Recognition Memory for Older Adults (Hits)
Time Frame: Week 5 Lab Visit (after about 2.5-3 weeks of training)
Recognition memory performance based on average proportion of previously presented images that were correctly identified (i.e., hits) by older adults
Week 5 Lab Visit (after about 2.5-3 weeks of training)
Recognition Memory for Younger Adults (False Alarm)
Time Frame: Week 5 Lab Visit (after about 2.5-3 weeks of training)
Recognition memory performance based on average proportion of images not previously presented that were incorrectly identified as seen (i.e., False Alarms) by younger adults
Week 5 Lab Visit (after about 2.5-3 weeks of training)
Recognition Memory for Older Adults (False Alarm)
Time Frame: Week 5 Lab Visit (after about 2.5-3 weeks of training)
Recognition memory performance based on average proportion of images not previously presented that were incorrectly identified as seen (i.e., False Alarms) by older adults
Week 5 Lab Visit (after about 2.5-3 weeks of training)
Recall Memory for Younger Adults
Time Frame: Week 5 Lab Visit (after about 2.5-3 weeks of training)
Average proportion of previously presented images that were correctly recalled by younger adults
Week 5 Lab Visit (after about 2.5-3 weeks of training)
Recall Memory for Older Adults
Time Frame: Week 5 Lab Visit (after about 2.5-3 weeks of training)
Average proportion of previously presented images that were correctly recalled by older adults
Week 5 Lab Visit (after about 2.5-3 weeks of training)
Stress Measured by Cortisol Levels for Younger Adults
Time Frame: Time 1 (Baseline), Time 2 (5 weeks)
Stress measured by salivary cortisol levels for younger adults
Time 1 (Baseline), Time 2 (5 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mara Mather, PhD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UP-17-00219

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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