Cardiovascular Disease Risk ReductionNCT07172152
Improving Minority Health Through Biofeedback and Stress Reduction
A study testing HRV Biofeedback Training in people with Cardiovascular Disease Risk Reduction and Chronic Stress, run by Amelia Saul, PhD, CTRS, BCB at 1 site in United States.
Trial summary
This study aims to evaluate the effectiveness of a four-week heart rate variability (HRV) biofeedback intervention to improve physiological stress response, emotion regulation, and anxiety-related symptoms in young ethnic minority adults with a family history of cardiovascular disease (CVD). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease Risk Reduction, Chronic Stress, Anxiety
- What is being tested?
- HRV Biofeedback Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults
- Age 18 to 35 years
- Cognitively intact to follow instructions
- English-speaking
- Family history of cardiovascular disease.
Who cannot join
- Cognitive impairments that inhibit understanding instruction
- Current diagnosis of hypertension that is controlled with prescribed medication
- Previously receiving biofeedback training
- Having a severe medical condition (e.g., pacemaker, cardiac arrhythmia, hypertension, diabetes)
- Being actively psychotic
- Having a neurological condition (e.g., Parkinson's disease) that would complicate the interpretation of physiological data
- Patients currently taking medications such as MAOIs, alpha/beta-blockers, or withdrawal or maintenance medications (e.g., Librium, methadone) are excluded due to their potential to affect the HRV data
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University
Miami, Florida, 33199
About this study
This study aims to evaluate the effectiveness of a four-week heart rate variability (HRV) biofeedback intervention to improve physiological stress response, emotion regulation, and anxiety-related symptoms in young ethnic minority adults with a family history of cardiovascular disease (CVD). Participants will be randomly assigned to either an intervention group, where they will engage in guided paced breathing exercises, or a control group, which will follow standard conditions without the intervention.
The study consists of five sessions, including an initial assessment, three weekly check-in sessions, and a final post-intervention assessment. Participants will practice paced breathing at home and attend brief in-lab sessions to track progress. Physiological and psychological measures, such as HRV, GSR, BP, anxiety levels, and responses to the Socially Evaluated Cold Pressor Test (SECPT), will be used to assess outcomes. Findings from this study may provide insights into accessible, non-invasive stress management interventions to mitigate CVD risk in high-risk populations.
Read the detailed description
Cardiovascular disease (CVD) is the leading cause of death in the United States, disproportionately affecting racial and ethnic minority populations. Chronic stress has been identified as a significant risk factor for CVD, yet few interventions address stress reduction as a preventative measure. This study investigates whether HRV biofeedback training can serve as an effective, non-pharmacological intervention to improve stress resilience and reduce risk factors associated with CVD.
- Conditions
- Cardiovascular Disease Risk Reduction, Chronic Stress, Anxiety, Emotional Regulation, Hypertension Prevention, Health Disparities
- Being tested
- HRV Biofeedback Training
- Keywords
- Heart Rate Variability, Biofeedback, Stress Reduction, Anxiety Management, Cardiovascular Health, Emotional Regulation, Preventative Health, Mind-Body Intervention
- Medical subject headings
- Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV Biofeedback TrainingBehavioural
Also called HRVB
Participants will be trained to use HRV biofeedback through paced breathing exercises (6 breaths per minute) twice daily over a four-week period.
| Study group | Role | What they receive |
|---|---|---|
| HRV Biofeedback Intervention Group | Experimental | Participants in this group will receive HRV biofeedback training for four weeks. They will attend five sessions: an initial baseline session, three weekly check-in sessions, and a final post-intervention assessment.
HRV biofeedback training will utilize an app that will provide guidance to participants to follow a pacer and breathe for 10 minutes and feedback will be provided. Receives: Behavioral: HRV Biofeedback Training |
| Control Group | No intervention | Participants in this group will complete baseline and post-study assessments but will not receive the HRV biofeedback intervention. They will continue their usual daily activities without specific stress management training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability Improvement
HRV will be assessed using the OptimalHRV sensor to determine improvements in autonomic regulation and stress resilience.
Measured: 4 weeks
State Anxiety Reduction (Beck Anxiety Inventory - BAI)
Changes in self-reported state anxiety levels will be assessed before and after the HRV biofeedback intervention using the Beck Anxiety Inventory (BAI). The BAI is a 21-item self-report questionnaire designed to measure anxiety severity. Each item is scored on a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"), resulting in a total score ranging from 0 to 63. Higher scores indicate greater levels of anxiety, while lower scores indicate reduced anxiety.
Measured: 4 weeks
Stress Resilience Under Acute Stress (Socially Evaluated Cold Pressor Test - SECPT)
The Socially Evaluated Cold Pressor Test (SECPT) will be used to measure changes in both self-reported and physiological stress responses to an acute stressor. Self-reported distress will be measured using a Visual Analog Scale, a 0-10 scale where 0 = no pain and 10 = worst possible pain. Higher scores indicate worse outcomes (greater distress). Emotional response will be measured using the Self-Assessment Manikin (SAM), which assesses valence, arousal, and dominance on a 5-point pictorial scale. Scores are coded such that higher valence = more positive affect, higher arousal = greater activation, and higher dominance = greater sense of control.
Measured: 4 weeks
Secondary outcomes (2)
Blood Pressure
Change in systolic and diastolic blood pressure.
Measured: 4 weeks
Galvanic Skin Response (GSR; Electrodermal Activity)
Change in skin conductance level (SCL) and response frequency during stress and recovery tasks.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start15 Sep 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Disease Risk ReductionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study follows a randomized controlled trial (RCT) design with a parallel assignment of participants into two groups: Intervention Group: Receives a four-week HRV biofeedback training. Control Group: No intervention, continues with usual activities.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amelia Saul, PhD, CTRS, BCB
- Sponsor type
- University, hospital or other
- Collaborators
- University of Puerto Rico
- Responsible party
- Sponsor-investigator, Amelia Saul, PhD, CTRS, BCB, Florida International University
- Investigators
- Amelia D Saul, PhD, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172152
- Sponsor's protocol ID
- RB-23-0122-AM02
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
PubMed 29034226Bolin LP, Saul AD, Bethune Scroggs LL, Horne C. A pilot study investigating the relationship between heart rate variability and blood pressure in young adults at risk for cardiovascular disease. Clin Hypertens. 2022 Jan 15;28(1):2. doi: 10.1186/s40885-021-00185-z.
PubMed 35031077
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Minority Health Through Biofeedback and Stress Reduction
- ClinicalTrials.gov ID
- NCT07172152
- Acronym / sponsor ID
- RB-23-0122-AM02
- Conditions
- Cardiovascular Disease Risk Reduction, Chronic Stress, Anxiety, Emotional Regulation, Hypertension Prevention, Health Disparities
- Keywords
- Heart Rate Variability, Biofeedback, Stress Reduction, Anxiety Management, Cardiovascular Health, Emotional Regulation, Preventative Health, Mind-Body Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Amelia Saul, PhD, CTRS, BCBUniversity, hospital or other
- Collaborators
- University of Puerto Rico
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of a four-week heart rate variability (HRV) biofeedback intervention to improve physiological stress response, emotion regulation, and anxiety-related symptoms in young ethnic minority adults with a family history of cardiovascular disease (CVD). Participants will be randomly assigned to either an intervention group, where they will engage in guided paced breathing exercises, or a control group, which will follow standard conditions without the intervention.
The study consists of five sessions, including an initial assessment, three weekly check-in sessions, and a final post-intervention assessment. Participants will practice paced breathing at home and attend brief in-lab sessions to track progress. Physiological and psychological measures, such as HRV, GSR, BP, anxiety levels, and responses to the Socially Evaluated Cold Pressor Test (SECPT), will be used to assess outcomes. Findings from this study may provide insights into accessible, non-invasive stress management interventions to mitigate CVD risk in high-risk populations.
Detailed description
Cardiovascular disease (CVD) is the leading cause of death in the United States, disproportionately affecting racial and ethnic minority populations. Chronic stress has been identified as a significant risk factor for CVD, yet few interventions address stress reduction as a preventative measure. This study investigates whether HRV biofeedback training can serve as an effective, non-pharmacological intervention to improve stress resilience and reduce risk factors associated with CVD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study follows a randomized controlled trial (RCT) design with a parallel assignment of participants into two groups: Intervention Group: Receives a four-week HRV biofeedback training. Control Group: No intervention, continues with usual activities.
| Arm | Type | Receives |
|---|---|---|
| HRV Biofeedback Intervention Group | Experimental | Behavioral: HRV Biofeedback TrainingParticipants in this group will receive HRV biofeedback training for four weeks. They will attend five sessions: an initial baseline session, three weekly check-in sessions, and a final post-intervention assessment. HRV biofeedback training will utilize an app that will provide guidance to participants to follow a pacer and breathe for 10 minutes and feedback will be provided. |
| Control Group | No intervention | –Participants in this group will complete baseline and post-study assessments but will not receive the HRV biofeedback intervention. They will continue their usual daily activities without specific stress management training. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults
- Age 18 to 35 years
- Cognitively intact to follow instructions
- English-speaking
- Family history of cardiovascular disease.
Key exclusion criteria (7 listed)
- Cognitive impairments that inhibit understanding instruction
- Current diagnosis of hypertension that is controlled with prescribed medication
- Previously receiving biofeedback training
- Having a severe medical condition (e.g., pacemaker, cardiac arrhythmia, hypertension, diabetes)
- Being actively psychotic
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 Biofeedback TrainingAlso: HRVBParticipants will be trained to use HRV biofeedback through paced breathing exercises (6 breaths per minute) twice daily over a four-week period. | Behavioural | HRV Biofeedback Intervention Group |
Primary outcome
Heart Rate Variability Improvement
Time frame: 4 weeks
HRV will be assessed using the OptimalHRV sensor to determine improvements in autonomic regulation and stress resilience.
State Anxiety Reduction (Beck Anxiety Inventory - BAI)
Time frame: 4 weeks
Changes in self-reported state anxiety levels will be assessed before and after the HRV biofeedback intervention using the Beck Anxiety Inventory (BAI). The BAI is a 21-item self-report questionnaire designed to measure anxiety severity. Each item is scored on a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Severely-it bothered me a lot"), resulting in a total score ranging from 0 to 63. Higher scores indicate greater levels of anxiety, while lower scores indicate reduced anxiety.
Stress Resilience Under Acute Stress (Socially Evaluated Cold Pressor Test - SECPT)
Time frame: 4 weeks
The Socially Evaluated Cold Pressor Test (SECPT) will be used to measure changes in both self-reported and physiological stress responses to an acute stressor. Self-reported distress will be measured using a Visual Analog Scale, a 0-10 scale where 0 = no pain and 10 = worst possible pain. Higher scores indicate worse outcomes (greater distress). Emotional response will be measured using the Self-Assessment Manikin (SAM), which assesses valence, arousal, and dominance on a 5-point pictorial scale. Scores are coded such that higher valence = more positive affect, higher arousal = greater activation, and higher dominance = greater sense of control.
2 secondary outcomes
Blood Pressure
Time frame: 4 weeks
Galvanic Skin Response (GSR; Electrodermal Activity)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Results publication: PubMed 29034226Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
- Results publication: PubMed 35031077Bolin LP, Saul AD, Bethune Scroggs LL, Horne C. A pilot study investigating the relationship between heart rate variability and blood pressure in young adults at risk for cardiovascular disease. Clin Hypertens. 2022 Jan 15;28(1):2. doi: 10.1186/s40885-021-00185-z.
- Individual participant dataSharing planned: Undecided
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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.
Amelia D Saul, PhD principal investigator
Florida International University
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 Biofeedback Training in people with Cardiovascular Disease Risk Reduction and Chronic Stress, run by Amelia Saul, PhD, CTRS, BCB 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 7 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: finished, as of the sponsor's last update on 8 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Heart Rate Variability Improvement (time frame: 4 weeks). The study lists 3 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 NCT07172152, which also lists 2 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 8 May 2026.