Heart Rate Variability Biofeedback for Depression

(RAPID Trial)

Overseen By Umiemah Farrukh

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Southern California

Must not be taking: Psychotropics

Disqualifiers: Autism, Eating disorder, Substance use, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

252 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a biofeedback treatment designed to help individuals manage depression by focusing on heart rate variability, which affects mood regulation. It examines how well participants manage emotions in daily life and how their nervous system responds during emotional regulation. Participants will use a biofeedback device at home to learn to control their heart rate through paced breathing. This trial is suitable for young adults aged 18-27 who have experienced major depressive disorder but are currently in full remission, or for healthy volunteers with no psychiatric history. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to developing new depression therapies.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have changed your psychotropic medication in the last 30 days to participate.

What prior data suggests that heart rate variability biofeedback is safe for treating depression?

Research shows that heart rate variability biofeedback (HRVB) is generally safe. Participants in past studies have handled HRVB well, experiencing improvements in issues like depression and stress. For instance, one study found that 81% of participants reported fewer symptoms of depression after using HRVB.

While researchers continue to study HRVB, it has shown potential benefits without major safety concerns. Participants have not reported serious side effects from this method so far. Since this trial is in an early stage, it focuses on the treatment's effectiveness and safety. Serious risks are likely low, but ongoing research will continue to gather more information. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for depression?

Researchers are excited about heart rate variability biofeedback for depression because it offers a unique approach by leveraging physiological processes to influence mental health. Unlike standard treatments like antidepressants or psychotherapy, this method uses paced breathing to help participants actively engage with their heart rate patterns, potentially enhancing emotional regulation. The innovative aspect lies in its non-invasive nature and the ability to provide immediate feedback, allowing participants to see real-time changes in their heart rate and adjust their breathing accordingly. This biofeedback process might offer a new way to manage depression, focusing on empowering individuals to influence their own bodily responses, which could be especially appealing for those seeking alternatives to medication.

What evidence suggests that heart rate variability biofeedback is effective for depression?

Research shows that heart rate variability biofeedback (HRVB) can help reduce symptoms of depression. In this trial, participants will join different treatment arms to explore HRVB's effects. In the Osc+ condition, participants will engage in paced breathing to maximize heart rate oscillations. In the Osc- condition, participants will focus on maintaining a steady heart rate. A review of several studies has found that HRVB improves mental health by easing both physical and emotional symptoms. Another study found that HRVB can lower depression scores and improve heart rate variability, which is linked to better mood control. Overall, these findings suggest that HRVB could be a useful tool for managing depression by helping the body better handle stress and emotions. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for young adults who have had major depressive disorder but are currently in remission, as well as healthy volunteers. Participants should be interested in monitoring their mood and bodily responses daily. People with ongoing depression or those unable to commit to the study's procedures cannot participate.

Inclusion Criteria

Age 18-27.

Meeting criteria for lifetime major depressive disorder.

Currently meeting criteria for full remission (absence of clinically significant symptoms) for at least eight weeks, and having a Hamilton Depression Rating Scale score of less than or equal to 7.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life

10 days

Intervention

Participants engage in a remote, self-administered biofeedback intervention designed to increase parasympathetic activity and physiological regulation success

10 days

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Heart rate variability biofeedback

Trial Overview The study tests if heart rate variability biofeedback can help people better regulate their emotions by increasing parasympathetic nervous system activity. It involves daily self-monitoring and a remote, self-administered intervention over 10 days, comparing it against a control group.

How Is the Trial Designed?

Group I: Osc+ Experimental Treatment 1 Intervention

Osc+ condition. In the Osc+ condition, participants will see an on-going record of their heart rate over time. They will be instructed to engage in paced breathing and to try to maximize their oscillation score. The paced breathing will be adapted to a rate that allows them to maximize their high amplitude heart rate oscillations.

Group II: Osc- Active Control 1 Intervention

Osc- condition. In the Osc- condition, participants will also see an on-going record of their heart rate over time, and will be instructed to engage in paced breathing. However, they will be asked to try to keep their heart rate steady and avoid oscillations and will get points on an 'alertness' score that inverts the Osc+ 'oscillation' score.

Heart rate variability biofeedback is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Heart rate variability biofeedback for:

• Anxiety disorders
• Depression
• Post-traumatic stress disorder (PTSD)
• Chronic pain management

Approved in European Union as Heart rate variability training for:

• Anxiety disorders
• Depression
• Stress management
• Sleep disorders

Approved in Canada as HRV biofeedback for:

• Anxiety disorders
• Depression
• Chronic pain management
• Stress management

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Heart rate variability biofeedback (HRVB) is a safe and feasible non-drug treatment for chronic disease patients, showing no adverse effects across 29 studies.

HRVB demonstrated significant positive effects on various health issues, including hypertension, asthma, depression, and sleep disturbances, potentially improving patients' quality of life by enhancing heart rate variability and autonomic function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart rate variability biofeedback in chronic disease management: A systematic review. Fournié, C., Chouchou, F., Dalleau, G., et al.[2021]

In a study involving 14 patients with moderate to severe depression, HRV biofeedback significantly reduced depression symptoms and anxiety, while also increasing heart rate variability (HRV) after just 6 sessions over two weeks.

The results suggest that HRV biofeedback could be a beneficial addition to depression treatment, as it specifically improved outcomes in depressed patients without affecting healthy controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study on the effects of heart rate variability biofeedback in patients with depression and in healthy subjects. Siepmann, M., Aykac, V., Unterdörfer, J., et al.[2022]

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]

Combining heart rate variability biofeedback (HRVB) with psychotherapy significantly improves heart rate variability and reduces depressive symptoms in individuals with major depressive disorder (MDD) over a six-week period, compared to standard psychotherapy alone.

The study utilized a randomized controlled design, highlighting the effectiveness of HRVB as a supplementary treatment for enhancing outcomes in MDD, as the psychotherapy-only group did not show improvements in heart rate variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adding HRV biofeedback to psychotherapy increases heart rate variability and improves the treatment of major depressive disorder. Caldwell, YT., Steffen, PR.[2022]

Heart rate variability biofeedback (HRVB) has a medium effect size (g = 0.38) in reducing depressive symptoms among adults, based on a meta-analysis of 14 randomized controlled trials involving 794 participants.

The effectiveness of HRVB in improving depressive symptoms is influenced by factors such as the year of publication and the specific questionnaires used to assess symptoms, indicating that it is a valid technique for enhancing psychological well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis on heart rate variability biofeedback and depressive symptoms. Pizzoli, SFM., Marzorati, C., Gatti, D., et al.[2023]

Heart rate variability biofeedback (HRVB) significantly reduces depressive symptoms in adult patients with comorbid conditions, showing a moderate effect size (g=0.478) based on a meta-analysis of 9 studies with 428 participants.

HRVB also improves heart rate variability (HRV) outcomes, albeit to a lesser extent (g=0.223), indicating that while both symptoms and physiological measures improve, the relationship between the two is moderately negative and non-significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis investigating the outcomes and correlation between heart rate variability biofeedback training on depressive symptoms and heart rate variability outcomes versus standard treatment in comorbid adult populations. Donnelly, D., Georgiadis, E., Stavrou, N.[2023]

The FitLab Game, a serious game designed to teach heart rate variability biofeedback (HRVB), showed significant improvements in heart rate variability (HRV) among participants who received training in breathing techniques, indicating its potential as an effective self-regulation tool.

Participants using the FitLab Game demonstrated enhanced performance and engagement, suggesting that the game's design effectively promotes attention and control, making it a promising intervention for managing arousal and improving self-control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Serious Game to Self-Regulate Heart Rate Variability as a Technique to Manage Arousal Level Through Cardiorespiratory Biofeedback: Development and Pilot Evaluation Study. Estrella, T., Alfonso, C., Ramos-Castro, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10440763/

A meta-analysis investigating the outcomes and correlation ... This meta-analysis aims to evaluate whether HRVB is a useful tool to reduce depressive symptoms and improve HRV relative to standard treatment in adult ...

2. nature.com nature.com/articles/s41598-021-86149-7

A meta-analysis on heart rate variability biofeedback and ... Numerous studies have demonstrated the positive effect of HRVB in reducing physical and psychological symptoms and increasing wellbeing.

3. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2023.1147260/full

Assessing effectiveness of heart rate variability ... 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.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0965229921000911

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 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06695715

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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10206049/

Assessing effectiveness of heart rate variability biofeedback to ... After intervention, all these profiles improved; the risk of PTSD reduced to 28.6%, the majority presented low symptoms of depression (81%), ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S030645222400126X

The Predictive Potential of Heart Rate Variability for ... This review highlights the possible predictive value of HRV as a biomarker for depression and its potential as a treatment target for improving depression.

8. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2014.00756/full

Heart rate variability biofeedback: how and why does it work? Effectiveness and safety of vagus nerve stimulation for severe treatment-resistant major depression in Clinical practice after FDA approval: outcomes at 1 year.