Project description:A rise in the prevalence of depression underscores the need for accessible and effective interventions. The objectives of this study were to determine if the addition of a treatment component showing promise in treating depression, heart rate variability-biofeedback (HRV-B), to our original smartphone-based, 8-week digital intervention was feasible and whether patients in the HRV-B ("enhanced") intervention were more likely to experience clinically significant improvements in depressive symptoms than patients in our original ("standard") intervention. We used a quasi-experimental, non-equivalent (matched) groups design to compare changes in symptoms of depression in the enhanced group (n = 48) to historical outcome data from the standard group (n = 48). Patients in the enhanced group completed a total average of 3.86 h of HRV-B practice across 25.8 sessions, and were more likely to report a clinically significant improvement in depressive symptom score post-intervention than participants in the standard group, even after adjusting for differences in demographics and engagement between groups (adjusted OR 3.44, 95% CI [1.28-9.26], P = .015). Our findings suggest that adding HRV-B to an app-based, smartphone-delivered, remote intervention for depression is feasible and may enhance treatment outcomes.
Project description:BackgroundPeople with autism spectrum disorder (ASD) frequently experience high levels of anxiety. Despite this, many clinical settings do not provide specialist ASD mental health services, and demand for professional support frequently outstrips supply. Across many sectors of health, investigators have explored digital health solutions to mitigate demand and extend the reach of professional practice beyond traditional clinical settings.ObjectiveThis critical appraisal and pilot feasibility study examines heart rate variability (HRV) biofeedback as an approach to help young people with ASD to manage anxiety symptoms outside of formal settings. The aim is to explore the use of portable biofeedback devices to manage anxiety, while also highlighting the risks and benefits of this approach with this population.MethodsWe assessed the feasibility of using home-based HRV biofeedback for self-management of anxiety in young people with ASD. We adopted coproduction, involving people with ASD, to facilitate development of the study design. Next, a separate pilot with 20 participants with ASD (n=16, 80% male participants and n=4, 20% female participants, aged 13-24 years; IQ>70) assessed adoption and acceptability of HRV biofeedback devices for home use over a 12-week period. Data were collected from both carers and participants through questionnaires and interviews; participants also provided single-lead electrocardiogram recordings as well as daily reports through smartphone on adoption and use of their device.ResultsPre-post participant questionnaires indicated a significant reduction in anxiety in children (t6=2.55; P=.04; Cohen d=0.99) as well as adults (t7=3.95; P=.006; Cohen d=0.54). Participant age was significantly negatively correlated with all HRV variables at baseline, namely high-frequency heart rate variability (HF-HRV: P=.02), the root mean square of successive differences in normal heartbeat contractions (RMSSD: P=.02) and the variability of normal-to-normal interbeat intervals (SDNN: P=.04). At follow-up, only SDNN was significantly negatively correlated with age (P=.05). Levels of ASD symptoms were positively correlated with heart rate both before (P=.04) and after the intervention (P=.01). The majority (311/474, 65.6%) of reports from participants indicated that the devices helped when used. Difficulties with the use of some devices and problems with home testing of HRV were noted. These initial findings are discussed within the context of the strengths and challenges of remotely delivering a biofeedback intervention for people with ASD.ConclusionsHRV biofeedback devices have shown promise in this pilot study. There is now a need for larger evaluation of biofeedback to determine which delivery methods achieve the greatest effect for people with ASD.Trial registrationClinicalTrials.gov NCT04955093; https://clinicaltrials.gov/ct2/show/NCT04955093.
Project description:IntroductionPost-COVID-19 syndrome, or Long Covid (LC) refers to symptoms persisting 12 weeks after the COVID-19 infection. LC comprises a wide range of dysautonomia symptoms, including fatigue, breathlessness, palpitations, dizziness, pain and brain fog. This study tested the feasibility and estimated the efficacy, of a Heart Rate Variability Biofeedback (HRV-B) programme via a standardised slow diaphragmatic breathing technique in individuals with LC.MethodsLC patients underwent a 4-week HRV-B intervention for 10 minutes twice daily for 4 weeks using the Polar H10 ECG (Electrocardiogram) chest strap and Elite HRV phone application. Outcome measures C19-YRSm (Yorkshire Rehabilitation Scale modified), Composite Autonomic Symptom Score (COMPASS-31), WHO Disability Assessment Schedule (WHODAS), EQ5D-5L (EuroQol 5 Dimensions) and Root Mean Square of Successive Differences between heartbeats (RMSSD) using a Fitbit device were recorded before and after the intervention. The study was pre-registered at clinicaltrials.gov NCT05228665.ResultsA total of 13 participants (54% female, 46% male) completed the study with high levels of independent use of technology, data completeness and intervention adherence. There was a statistically significant improvement in C19YRS-m (P = .001), COMPASS-31 (P = .007), RMSSD (P = .047), WHODAS (P = .02) and EQ5D Global Health Score (P = .009). Qualitative feedback suggested participants could use it independently, were satisfied with the intervention and reported beneficial effects from the intervention.ConclusionHRV-B using diaphragmatic breathing is a feasible intervention for LC. The small sample size limits generalisability. HRV-B in LC warrants further exploration in a larger randomised controlled study.
Project description:IntroductionLong COVID (LC), also known as post-COVID-19 syndrome, refers to symptoms persisting 12 weeks after COVID-19 infection. It affects up to one in seven people contracting the illness and causes a wide range of symptoms, including fatigue, breathlessness, palpitations, dizziness, pain and brain fog. Many of these symptoms can be linked to dysautonomia or dysregulation of the autonomic nervous system after SARS-CoV2 infection. This study aims to test the feasibility and estimate the efficacy, of the heart rate variability biofeedback (HRV-B) technique via a standardised slow diaphragmatic breathing programme in individuals with LC.Methods and analysis30 adult LC patients with symptoms of palpitations or dizziness and an abnormal NASA Lean Test will be selected from a specialist Long COVID rehabilitation service. They will undergo a 4-week HRV-B intervention using a Polar chest strap device linked to the Elite HRV phone application while undertaking the breathing exercise technique for two 10 min periods everyday for at least 5 days a week. Quantitative data will be gathered during the study period using: HRV data from the chest strap and wrist-worn Fitbit, the modified COVID-19 Yorkshire Rehabilitation Scale, Composite Autonomic Symptom Score, WHO Disability Assessment Schedule and EQ-5D-5L health-related quality of life measures. Qualitative feedback on user experience and feasibility of using the technology in a home setting will also be gathered. Standard statistical tests for correlation and significant difference will be used to analyse the quantitate data.Ethics and disseminationThe study has received ethical approval from Health Research Authority (HRA) Leicester South Research Ethics Committee (21/EM/0271). Dissemination plans include academic and lay publications.Trial registration numberNCT05228665.
Project description:Introduction: The increasing burden on mental health has become a worldwide concern especially due to its substantial negative social and economic impact. The implementation of prevention actions and psychological interventions is crucial to mitigate these consequences, and evidence supporting its effectiveness would facilitate a more assertive response. Heart rate variability biofeedback (HRV-BF) has been proposed as a potential intervention to improve mental wellbeing through mechanisms in autonomic functioning. The aim of this study is to propose and evaluate the validity of an objective procedure to assess the effectiveness of a HRV-BF protocol in mitigating mental health symptoms in a sample of frontline HCWs (healthcare workers) who worked in the COVID-19 pandemic. Methods: A prospective experimental study applying a HRV-BF protocol was conducted with 21 frontline healthcare workers in 5 weekly sessions. For PRE-POST intervention comparisons, two different approaches were used to evaluate mental health status: applying (a) gold-standard psychometric questionnaires and (b) electrophysiological multiparametric models for chronic and acute stress assessment. Results: After HRV-BF intervention, psychometric questionnaires showed a reduction in mental health symptoms and stress perception. The electrophysiological multiparametric also showed a reduction in chronic stress levels, while the acute stress levels were similar in PRE and POST conditions. A significant reduction in respiratory rate and an increase in some heart rate variability parameters, such as SDNN, LFn, and LF/HF ratio, were also observed after intervention. Conclusion: 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 who worked during the COVID-19 pandemic. The electrophysiological multiparametric models provide relevant information about the current mental health state, being useful for objectively evaluating the effectiveness of stress-reducing interventions. Further research could replicate the proposed procedure to confirm its feasibility for different samples and specific interventions.
Project description:IntroductionPatients undergoing treatment for cancer who require radiation therapy (RT) report anxiety specifically relating to the RT procedure. Procedural anxiety can be detrimental to treatment delivery, causing disruptions to treatment sessions, or treatment avoidance. Acute procedural anxiety is most commonly managed with anxiolytic medication. There is a need for effective, non-pharmacological interventions for patients not suitable for, or who prefer to avoid, anxiolytic medication. The primary objectives of this pilot trial are to evaluate the: (1) feasibility of conducting the Biofeedback Enabled CALM (BeCALM) intervention during RT treatment sessions; (2) acceptability of the BeCALM intervention among patients; and (3) acceptability of the BeCALM intervention among radiation therapists. The secondary objective of this pilot trial is to examine the potential effectiveness of the BeCALM intervention delivered by radiation therapists to reduce procedural anxiety during RT.Methods and analysisThis is a pilot randomised controlled trial. A researcher will recruit adult patients with cancer (3-month recruitment period) scheduled to undergo RT and meeting eligibility criteria for procedural anxiety at the Calvary Mater Hospital, Newcastle (NSW), Australia. Participants will be randomly assigned to receive treatment as usual or the BeCALM intervention (biofeedback plus brief breathing techniques). The primary outcomes are feasibility (measured by recruitment, retention rates and percentage of treatment sessions in which the intervention was successfully delivered); radiation therapists perceived feasibility and acceptability (survey responses); and patient perceived acceptability (survey responses). Secondary outcome is potential effectiveness of the intervention (as measured by the State Trait Anxiety Inventory-State subscale; the Distress Thermometer; and an analysis of treatment duration).Ethics and disseminationThe study protocol has received approval from Hunter New England Health Human Research Ethics Committee (2021/ETH11356). The results will be disseminated via peer-reviewed publications, as well as presentation at relevant conferences.Trial registration numberACTRN12621001742864.
Project description:Background: A commonly observed phenomenon is that although the players in a baseball team have received the same training content and volume, their batting performance is quite different. As no optimal solution exists for this problem at present, this study attempted to explore the potential of heart rate variability biofeedback (HRVB) to reduce anxiety and improve batting performance in university baseball players. Materials and Methods: A total of 18 college baseball players were randomly divided into an experimental group and a control group. Both groups answered questionnaires and had their physiological signals and batting performance measured on the first and last days of the experiment (i.e., days 0 and 10, respectively). Only the experimental group received HRVB training between the first and last days (10 days in total). Results: The results showed that before training, no significant differences were found in physiological, psychological, or performance parameters between the two groups. Compared to the control group, following HRVB training, the experimental group showed a notable decrease in cognitive anxiety (before HRVB: 23.56 ± 4.07; after HRVB: 20.11 ± 4.78; p < 0.05) and their batting performance improved significantly (batting score increased from 9.8 ± 11.7 to 19.8 ± 12.0 after HRVB; p < 0.05). Conclusions: This study validated that the use of HRVB can help to improve batting performance and reduce anxiety in college baseball players. Therefore, HRVB can be applied before competition matches, helping the players to perform better.
Project description:Background: Neurocardiac dysfunction worsens clinical outcome and increases mortality in stroke survivors. We hypothesized that heart rate variability (HRV) biofeedback improves neurocardiac function by modulating autonomic nervous system activity after acute ischaemic stroke (AIS). Methods: We randomly allocated (1:1) 48 acute ischaemic stroke patients to receive nine sessions of HRV- or sham biofeedback over 3 days in addition to comprehensive stroke unit care. Before and after the intervention patients were evaluated for HRV via standard deviation of normal-to-normal intervals (SDNN, primary outcome), root mean square of successive differences between normal heartbeats (RMSSD), a predominantly parasympathetic measure, and for sympathetic vasomotor and sudomotor function. Severity of autonomic symptoms was assessed via survey of autonomic symptom scale total impact score (TIS) at baseline and after 3 months. Results: We included 48 patients with acute ischaemic stroke [19 females, ages 65 (4.4), median (interquartile range)]. Treatment with HRV biofeedback increased HRV post intervention [SDNN: 43.5 (79.0) ms vs. 34.1 (45.0) ms baseline, p = 0.015; RMSSD: 46.0 (140.6) ms vs. 29.1 (52.2) ms baseline, p = 0.015] and alleviated autonomic symptoms after 3 months [TIS 3.5 (8.0) vs. 7.5 (7.0) baseline, p = 0.029], which was not seen after sham biofeedback (SDNN: p = 0.63, RMSSD: p = 0.65, TIS: 0.06). There were no changes in sympathetic vasomotor and sudomotor function (p = ns). Conclusions: Adding HRV biofeedback to standard stroke unit care led to improved neurocardiac function and sustained alleviation of autonomic symptoms after acute ischaemic stroke, which was likely mediated by a predominantly parasympathetic mechanism. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03865225.
Project description: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.
Project description:ObjectiveRecent studies suggest that lower resting heart rate variability (HRV) is associated with elevated vulnerability to depressive rumination. In this study, we tested whether increases in HRV after HRV-biofeedback training are accompanied by reductions in rumination levels.Materials and methodsSixteen patients suffering from depression completed a 6-week HRV-biofeedback training and fourteen patients completed a control condition in which there was no intervention (waitlist). The training included five sessions per week at home using a smartphone application and an ECG belt. Depressive symptoms and autonomic function at rest and during induced rumination were assessed before and after each of the two conditions. We used a well-established rumination induction task to provoke a state of pervasive rumination while recording various physiological signals simultaneously. Changes in HRV, respiration rate, skin conductance, and pupil diameter were compared between conditions and time points.ResultsA significant correlation was found between resting HRV and rumination levels, both assessed at the first laboratory session (r = -0.43, p < 0.05). Induction of rumination led to an acceleration of heart rate and skin conductance increases. After biofeedback training, resting vagal HRV was increased (p < 0.01) and self-ratings of state anxiety (p < 0.05), rumination (p < 0.05), perceived stress (p < 0.05), and depressive symptoms (QIDS, BDI; both p < 0.05) were decreased. In the control condition, there were no changes in autonomic indices or depressive symptomatology. A significant interaction effect group x time on HRV was observed.ConclusionOur results indicate that a smartphone-based HRV-biofeedback intervention can be applied to improve cardiovagal function and to reduce depressive symptoms including self-rated rumination tendencies.