Heart Rate Variability Biofeedback for Depression
(RAPID Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Southern California
Must not be taking: Psychotropics
Disqualifiers: Autism, Eating disorder, Substance use, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
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.
12345Is 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.
12467How 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.
12347Eligibility 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.
+2 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Osc+Experimental Treatment1 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 Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Southern CaliforniaLos Angeles, CA
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Who Is Running the Clinical Trial?
University of Southern CaliforniaLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Adding HRV biofeedback to psychotherapy increases heart rate variability and improves the treatment of major depressive disorder. [2022]Heart rate variability (HRV) is a significant marker of health outcomes with decreased HRV predicting increased disease risk. HRV is decreased in major depressive disorder (MDD) but existing treatments for depression do not return heart rate variability to normal levels even with successful treatment of depression. Heart rate variability biofeedback (HRVB) increases heart rate variability but no studies to date have examined whether combining HRVB with psychotherapy improves outcome in MDD treatment. The present study used a randomized controlled design to compare the effects of HRVB combined with psychotherapy on MDD relative to a psychotherapy treatment as usual group and to a non-depressed control group. The HRVB+psychotherapy group showed a larger increase in HRV and a larger decrease in depressive symptoms relative to the other groups over a six-week period, whereas the psychotherapy group only did not improve HRV. Results support the supplementation of psychotherapy with HRVB in the treatment of MDD.
A pilot study on the effects of heart rate variability biofeedback in patients with depression and in healthy subjects. [2022]Decreased vagal activity and increased sympathetic arousal have been proposed as major contributors to the increased risk of cardiovascular mortality in patients with depression. It was aim of the present study to assess the feasibility of using heart rate variability (HRV) biofeedback to treat moderate to severe depression. This was an open-label study in which 14 patients with different degrees of depression (13 f, 1 m) aged 30 years (18-47; median; range) and 12 healthy volunteers attended 6 sessions of HRV biofeedback over two weeks. Another 12 healthy subjects were observed under an active control condition. At follow up BDI was found significantly decreased (BDI 6; 2-20; median 25%-75% quartile) as compared to baseline conditions (BDI 22;15-29) in patients with depression. In addition, depressed patients had reduced anxiety, decreased heart rate and increased HRV after conduction of biofeedback (p
A meta-analysis on heart rate variability biofeedback and depressive symptoms. [2023]Heart rate variability biofeedback (HRVB) has been used for a number of years to treat depressive symptoms, a common mental health issue, which is often comorbid with other psychopathological and medical conditions. The aim of the present meta-analysis is to test whether and to what extent HRVB is effective in reducing depressive symptoms in adult patients. We conducted a literature search on Pubmed, ProQuest, Ovid PsycInfo, and Embase up to October 2020, and identified 721 studies. Fourteen studies were included in the meta-analysis. Three meta-regressions were also performed to further test whether publication year, the questionnaire used to assess depressive symptoms, or the interval of time between T0 and T1 moderated the effect of HRVB. Overall, we analysed 14 RCTs with a total of 794 participants. The random effect analysis yielded a medium mean effect size g = 0.38 [95% CI = 0.16, 0.60; 95% PI =  - 0.19, 0.96], z = 3.44, p = 0.0006. The total heterogeneity was significant, QT = 23.49, p = 0.03, I2 = 45%, which suggested a moderate variance among the included studies. The year of publication (χ2(1) = 4.08, p = 0.04) and the questionnaire used to assess symptoms (χ2(4) = 12.65, p = 0.01) significantly moderated the effect of the interventions and reduced heterogeneity. Overall, results showed that HRVB improves depressive symptoms in several psychophysiological conditions in adult samples and should be considered as a valid technique to increase psychological well-being.
One-Year Cardiovascular Prognosis of the Randomized, Controlled, Short-Term Heart Rate Variability Biofeedback Among Patients with Coronary Artery Disease. [2021]Heart rate variability biofeedback (HRV-BF) is an effective psychophysiological intervention, with short-term effects of increased autonomic nervous system homeostasis, strengthened baroreflex sensitivity, and decreased hostility in patients with coronary artery disease (CAD). The study examined the 1-year HRV-BF effect on cardiovascular prognosis of these patients.
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]Heart rate variability biofeedback (HRVB) has previously been used to ameliorate depressive symptoms but its uses for tackling depressive symptoms in an array of comorbid adult patients is less established. 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 comorbid populations, while also attempting to establish the association between the two outcomes.
Heart rate variability biofeedback in chronic disease management: A systematic review. [2021]Heart rate variability biofeedback (HRVB) is a non-pharmacological intervention used in the management of chronic diseases.
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]Heart rate variability biofeedback (HRVB) is an established intervention for increasing heart rate variability (HRV) in the clinical context. Using this technique, participants become aware of their HRV through real-time feedback and can self-regulate it.