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

Trial Summary

What is the purpose of this trial?

Although treatments for depression are effective for many people, not everyone responds to treatment. This lack of treatment response could be due, in part, to the presence of multiple underlying causes of people's depression. This study aims to identify subtypes of depression, based on two factors: how successful people perceive themselves to be at regulating their affect in everyday life; and how much activity in the parasympathetic nervous system increases during moments when people try to regulate. The study involves ambulatory assessment of affect, regulation strategies, and physiological activity in everyday life, in a sample of young adults with remitted major depressive disorder and healthy volunteers. We will study regulation responses in the lab to further determine how subtypes differ in neural, physiological, and behavioral responses. Finally, participants will be randomly assigned to a remote, self-administered biofeedback intervention (vs. control intervention) designed to increase parasympathetic activity and physiological regulation success. While engaging in biofeedback at home for 10 days, participants will simultaneously repeat the ambulatory assessments. This design will allow us to determine the proximal impact of biofeedback on indices of regulation success in everyday life, and whether biofeedback has differential impact on regulation success for different subtypes.

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 data supports the effectiveness of the treatment Heart rate variability biofeedback for depression?

Research shows that heart rate variability biofeedback (HRVB) can help improve symptoms of depression. Studies found that combining HRVB with psychotherapy increased heart rate variability and reduced depressive symptoms more than psychotherapy alone. Additionally, a meta-analysis confirmed that HRVB is effective in reducing depressive symptoms in adults. ^{1 2 3 4 5}

Is heart rate variability biofeedback safe for humans?

Heart rate variability biofeedback (HRVB) is generally considered safe for humans, as it is a non-drug intervention used in managing various conditions, including depression and chronic diseases. Studies have not reported significant safety concerns, and it is often used to improve heart rate variability and reduce symptoms in different health contexts. ^{1 2 4 6 7}

How does heart rate variability biofeedback treatment differ from other treatments for depression?

Heart rate variability biofeedback (HRV biofeedback) is unique because it helps patients learn to control their heart rate variability through real-time feedback, which can improve both heart health and depressive symptoms. Unlike traditional depression treatments, HRV biofeedback specifically targets the autonomic nervous system to increase heart rate variability, which is often reduced in depression. ^{1 2 3 4 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 (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 (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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. Germany pubmed.ncbi.nlm.nih.gov

A pilot study on the effects of heart rate variability biofeedback in patients with depression and in healthy subjects. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A meta-analysis on heart rate variability biofeedback and depressive symptoms. [2023]

4. England 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. [2021]

5. Italy 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. [2023]

6. Scotland pubmed.ncbi.nlm.nih.gov

Heart rate variability biofeedback in chronic disease management: A systematic review. [2021]

7. Canada 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. [2023]