64 Participants Needed

Biofeedback for Anxiety

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Overseen ByAmelia D Saul, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a breathing exercise using heart rate variability (HRV) biofeedback can help manage stress and anxiety in young adults. The researchers aim to determine if this non-invasive method can improve stress responses and emotional regulation, potentially reducing the risk of heart disease. Participants will either practice paced breathing with guidance or maintain their usual daily routines. Those who may be a good fit have a family history of heart disease and experience anxiety-related symptoms. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new stress management techniques.

Will I have to stop taking my current medications?

If you are taking medications like MAOIs, alpha/beta-blockers, or certain withdrawal or maintenance medications, you cannot participate in the trial. The protocol does not specify if you need to stop other medications, but these specific ones are excluded because they can affect the study's data.

What prior data suggests that this HRV biofeedback intervention is safe for young ethnic minority adults with a family history of cardiovascular disease?

Research shows that heart rate variability (HRV) biofeedback is safe and well-tolerated. Previous studies have found that HRV biofeedback effectively reduces stress and anxiety without significant side effects. For instance, one study with frontline healthcare workers showed that a 5-session HRV biofeedback program lowered stress and improved mental health. Another study suggested that HRV biofeedback might also reduce symptoms of depression and anxiety.

These studies indicate that HRV biofeedback is a promising and non-invasive treatment option, with no major side effects reported. This makes it a potentially safe choice for managing stress and anxiety, especially for those concerned about the side effects of more invasive treatments.12345

Why are researchers excited about this trial?

Researchers are excited about HRV biofeedback training for anxiety because it offers a non-invasive, drug-free approach to managing stress and anxiety. Unlike traditional medications that often involve chemicals and potential side effects, this method utilizes a simple app to guide breathing exercises, enhancing heart rate variability (HRV) to promote relaxation. Additionally, the immediate feedback provided during these sessions helps participants adjust and improve their stress management skills in real time, potentially leading to quicker and more sustainable anxiety relief. This innovative approach could provide an accessible and empowering alternative for individuals seeking to manage anxiety without medication.

What evidence suggests that HRV biofeedback is effective for anxiety?

Research has shown that heart rate variability (HRV) biofeedback can reduce stress and improve mental health. In earlier studies, participants using HRV biofeedback demonstrated better HRV, indicating improved stress management, enhanced overall well-being, and lower blood pressure. Other research suggests this method can decrease anxiety and depression symptoms by helping the body manage stress more effectively. For those with anxiety, higher HRV was linked to feeling less upset over time. These findings suggest HRV biofeedback is a promising and non-invasive way to manage anxiety and stress. Participants in this trial will be divided into two groups: the HRV Biofeedback Intervention Group, which will receive HRV biofeedback training, and a Control Group, which will not receive the intervention but will complete baseline and post-study assessments.12467

Who Is on the Research Team?

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Amelia D Saul, PhD

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

This trial is for young ethnic minority adults with a family history of cardiovascular disease who experience chronic stress, anxiety, or have heart conditions. Participants should be interested in non-invasive stress management techniques.

Inclusion Criteria

English-speaking
I am between 18 and 35 years old.
I can understand and follow instructions.
See 1 more

Exclusion Criteria

Actively psychotic
I have a severe medical condition like a heart problem or diabetes.
I have received biofeedback training before.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive HRV biofeedback training for four weeks, including an initial assessment, three weekly check-in sessions, and a final post-intervention assessment.

4 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • HRV Biofeedback Training
Trial Overview The study tests if HRV biofeedback training can help manage stress and improve emotion regulation over four weeks. It involves paced breathing exercises at home and weekly lab check-ins to measure progress against a control group.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: HRV Biofeedback Intervention GroupExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Amelia Saul, PhD, CTRS, BCB

Lead Sponsor

University of Puerto Rico Medical Campus

Collaborator

University of Puerto Rico

Collaborator

Trials
69
Recruited
22,300+

Citations

Assessing effectiveness of heart rate variability biofeedback to ...Our findings suggest that a 5-session HRV-BF protocol is an effective intervention for reducing stress and other mental health symptoms among frontline HCWs.
Effectiveness of Heart Rate Variability Biofeedback ...The objective of this trial is to evaluate the efficacy of a heart rate variability biofeedback training protocol, compared to a guided meditation program and ...
Heart rate variability biofeedback in a global study of the ...They share a number of common outcomes such as increased HRV, improved autonomic function, lower blood pressure and better overall well-being2,3 ...
Heart rate variability biofeedback in chronic disease ...Results showed an increase of both HRV-LF power and coherence ratio, and a decrease of both depression scores and resting breathing rate suggesting promising ...
Heart Rate Variability Predicts Therapy Outcome in Anxiety ...We found that high resting HRV was positively associated with lower subjective distress at one-month follow-up. Crucially, the mediation ...
Heart rate variability biofeedback: how and why does it work?Several studies have reported that HRVB might be effective in reducing symptoms of depression and/or anxiety (Karavidas et al., 2007; Reiner, 2008; Siepmann et ...
Effects of HRV Biofeedback, Interoceptive Training, and ...The goal of this clinical trial is to learn if Heart Rate Variability Biofeedback (HRV-BF), Mindfulness programs, and Interoception training can reduce ...
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