HRV Biofeedback for Caregiver Stress

(CARES Trial)

Overseen By Dara James, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Arizona State University

Must not be taking: Heart rate medications

Disqualifiers: Regular mind-body practice, pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two methods can help family caregivers of Alzheimer's patients manage stress and improve well-being. One method uses heart-focused breathing to control heart rate, while the other involves listening to music. Researchers aim to assess the impact of these methods on caregiver stress, anxiety, and relationship quality. Primary, unpaid caregivers with at least six months of experience and a smartphone may be suitable for this trial. As an unphased trial, it offers caregivers a unique opportunity to explore innovative stress management techniques.

Will I have to stop taking my current medications?

The trial excludes participants who are on medications that interfere with heart rate variability, so you may need to stop taking such medications to participate.

What prior data suggests that this heart rate variability biofeedback intervention is safe for family caregivers of Alzheimer's patients?

Research shows that heart-focused breathing is generally safe for most people. Studies have found that it positively affects the nervous system, reducing stress and anxiety by improving the coordination between heart and breathing. No major reports of side effects or problems have been linked to heart-focused breathing. This simple technique involves focusing on the heart area and breathing more deeply than usual. As a non-invasive method, it does not involve surgery or entering the body, which typically enhances its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Heart Focused Breathing technique for Alzheimer's caregivers because it offers a non-pharmacological approach to stress reduction. Unlike medications that often focus on chemical changes in the brain, this method emphasizes controlled breathing to potentially improve heart rate variability, which can lead to better stress management and emotional well-being. By addressing the caregiver's stress through a natural and accessible practice, it presents a promising alternative or complement to existing pharmacological treatments.

What evidence suggests that this trial's treatments could be effective for family caregivers of Alzheimer's disease patients?

Research shows that focusing on breathing can reduce stress and improve mental health. Studies have found that regular, guided breathing exercises can lift mood and lower anxiety. In this trial, participants will join either the Heart Focused Breathing group or the Music Listening Control (MLC) group. Previous studies showed bigger improvements in quality of life for the Music Listening Control group. However, the Heart Focused Breathing group demonstrated increased self-kindness and better heart rate patterns, indicating improved stress management. This suggests that heart-focused breathing might reduce stress and lessen the burden on caregivers. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

primary, unpaid family caregiver for ADRD patient for 6 months or more

owns and operates a smartphone with a data plan

greater than of equal to 4 on caregiver burden scale

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an 8-week heart rate variability biofeedback (HRVB) intervention or music listening control (MLC)

8 weeks

Follow-up

Participants are monitored for changes in caregiver burden, stress, resilience, anxiety, self-compassion, and relationship quality

5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Heart Focused Breathing
• Music Listening Control (MLC)

How Is the Trial Designed?

Group I: Heart Focused Breathing Experimental Treatment 1 Intervention

Group II: Music Listening Control(MLC) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Arizona State University

Lead Sponsor

Trials

311

Recruited

109,000+

Published Research Related to This Trial

Heart rate variability biofeedback (HRV-BF) significantly reduced hospital readmissions (12% vs. 25.42%) and emergency visits (13.33% vs. 35.59%) in patients with coronary artery disease over a 1-year period, indicating its effectiveness in improving cardiovascular prognosis.

The HRV-BF group showed long-term improvements in cardiac autonomic function and reductions in depression and hostility, suggesting that HRV-BF is a beneficial intervention for both psychological and physiological health in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-Year Cardiovascular Prognosis of the Randomized, Controlled, Short-Term Heart Rate Variability Biofeedback Among Patients with Coronary Artery Disease. Yu, LC., Lin, IM., Fan, SY., et al.[2021]

In a study of 107 patients with stable chronic heart failure, heart-focused anxiety was primarily predicted by self-reported anxiety levels and quality of life, highlighting the importance of psychological factors in these patients.

Additionally, factors such as conscientiousness, physical activity, and renal function (measured by estimated glomerular filtration rate, eGFR) were also found to be significant predictors of heart-focused anxiety, suggesting that both lifestyle and medical indicators can help identify patients at risk for adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of heart-focused anxiety in patients with stable heart failure. Wedegärtner, SM., Schwantke, I., Kindermann, I., et al.[2021]

Meditation practices have been shown to significantly improve psychosocial factors, quality of life, and reduce heart failure symptom burden in patients, based on a review of six studies involving 320 heart failure patients.

Despite the positive findings, the studies varied widely in their design and outcome measures, highlighting the need for more standardized and larger trials to better understand the effects of meditation on heart failure outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation interventions among heart failure patients: An integrative review. Viveiros, J., Chamberlain, B., O'Hare, A., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10741869/

Breathing Practices for Stress and Anxiety Reduction

Effective breath practices avoided fast-only breath paces and sessions <5 min, while including human-guided training, multiple sessions, and long-term practice.

2.

nature.com

nature.com/articles/s41598-022-27247-y

Effect of breathwork on stress and mental health: A meta- ...

Overall, results showed that breathwork may be effective for improving stress and mental health. However, we urge caution and advocate for nuanced research ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0197457221000641

Heart-focused breathing and perceptions of burden in ...

Quality of life improved significantly in the control group compared to intervention, while self-compassion and HRV trended towards the expected direction.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9873947/

Brief structured respiration practices enhance mood and ...

Breathwork produces greater improvement in mood and reduction in respiratory rate, while both result in reduction in negative emotion including state anxiety.

5.

heartmath.org

heartmath.org/articles-of-the-heart/the-math-of-heartmath/heart-focused-breathing/

Heart-Focused Breathing

Typically, HeartMath recommends that you breathe in about 5 to 6 seconds and breathe out 5 to 6 seconds. Be sure your breathing is smooth, ...

6.

neogen.com

neogen.com/4a2470/globalassets/pim/assets/original/10059/ncm0016_700003008_700003009_700003010_700003011_700004383_sds_en-mt.pdf

Brain Heart Infusion Broth - Safety Data Sheet

If breathing is difficult give oxygen. If breathing stops, provide artificial respiration. Seek medical attention if irritation or symptoms ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06849388

Effect of HeartMath Intervention on Stress, Emotional ...

Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... Review Heart-Focused Breathing and Quick Coherence Techniques. Review and ...

8.

heart.org

heart.org/en/news/2023/07/07/its-not-just-inspiration-careful-breathing-can-help-your-health

It's not just inspiration – careful breathing can help your ...

Other research has shown that deep breathing can improve blood glucose in healthy people.