Pilot Study on Reducing Symptoms of Anxiety with a Heart Rate Variability Biofeedback Wearable and Remote Stress Management Coach.

We assessed the feasibility of using a consumer friendly, heart rate variability biofeedback (HRVB) wearable device in conjunction with a remote stress management coach to reduce symptoms of anxiety. We utilized a discreet, continuously wearable electrocardiogram device, the Lief Smart Patch, which measures and records heart rate and HRV in real time, and guides HRVB exercises using vibrations and visual cues. During the 8-week study, participants (N = 14) wore the Lief Smart Patch, participated in HRVB with the device, utilized the mobile app, and communicated with a remote stress management coach. We collected self-report survey responses to measure symptoms of anxiety (GAD-2) and depression (PHQ-2) every 2 weeks, as well as HRV data throughout the study. Participants' mean GAD-2 score began at 4.6 out of 6. By the trial's completion, the group's mean GAD-2 score dropped to 1.7 (t(13) = 11.0, p < .001) with only 2 of the 14 subjects remaining over the clinical threshold of high anxiety. Similarly, the group's mean PHQ-2 score dropped from 2.93 to 1.29 (t(13) = 3.54, p < .01). In addition, participants increased their HRV (RMSSD) by an average of + 11.4 ms after participating in a low dose biofeedback exercise. These findings suggest that engaging in HRVB through a discreet wearable device in conjunction with a remote stress management program may be effective for reducing symptoms of anxiety and depression.

Heart Rate Variability and Cognitive Bias Feedback Interventions to Prevent Post-deployment PTSD: Results from a Randomized Controlled Trial.

Introduction: There is a long history of pre-deployment PTSD prevention efforts in the military and effective pre-deployment strategies to prevent post-deployment PTSD are still needed. Materials and Methods: This randomized controlled trial included three arms: heart rate variability biofeedback (HRVB), cognitive bias modification for interpretation (CBM-I), and control. The hypothesis was that pre-deployment resilience training would result in lower post-deployment PTSD symptoms compared with control. Army National Guard soldiers (n = 342) were enrolled in the Warriors Achieving Resilience (WAR) study and analyzed. The outcome was PTSD symptom severity using the PTSD Checklist - Military version (PCL) measured at pre-deployment, 3- and 12-month post-deployment. Due to the repeated measures for each participant and cluster randomization at the company level, generalized linear mixed models were used for the analysis. This study was approved by the Army Human Research Protection Office, Central Arkansas Veterans Healthcare System Institutional Review Board (IRB), and Southeast Louisiana Veterans Health Care System IRB. Results: Overall, there was no significant intervention effect. However, there were significant intervention effects for subgroups of soldiers. For example, at 3-months post-deployment, the HRVB arm had significantly lower PCL scores than the control arm for soldiers with no previous combat zone exposure who were age 30 and older and for soldiers with previous combat zone exposure who were 45 and older (unadjusted effect size -0.97 and -1.03, respectively). A significant difference between the CBM-I and control arms was found for soldiers without previous combat zone exposure between ages 23 and 42 (unadjusted effect size -0.41). Similarly, at 12-months post-deployment, the HRVB arm had significantly lower PCL scores in older soldiers. Conclusion: Pre-deployment resilience training was acceptable and feasible and resulted in lower post-deployment PTSD symptom scores in subgroups of older soldiers compared with controls. Strengths of the study included cluster randomization at the company level, use of iPod device to deliver the resilience intervention throughout the deployment cycle, and minimal disruption of pre-deployment training by using self-paced resilience training. Weaknesses included self-report app use, study personnel not able to contact soldiers during deployment, and in general a low level of PTSD symptom severity throughout the study. In future studies, it would important for the study team and/or military personnel implementing the resilience training to be in frequent contact with participants to ensure proper use of the resilience training apps.

Alcohol Use Disorder Moderates the Effect of Age on Heart Rate Variability in Veterans With Posttraumatic Stress Disorder.

Research on heart rate variability (HRV) in posttraumatic stress disorder (PTSD) and comorbid alcohol use disorder (AUD) is limited despite its use as a biomarker of both disorders. This study examined whether AUD comorbidity contributes an additive effect on HRV for veterans with PTSD. HRV was assessed in 70 male Operation Enduring Freedom/Operation Iraqi Freedom veterans with PTSD, including 32 with co-occurring AUD. Mean HRV values for both groups were below the mean for healthy adults, but additive effects of PTSD and AUD on HRV were not observed. Consistent with prior studies, hierarchical regressions showed that HRV decreased with age in the PTSD-only group. However, HRV increased slightly with age among veterans with both PTSD and AUD. This interaction remained significant after controlling for common HRV covariates. These findings support HRV as a biomarker of PTSD and extend research by demonstrating the complex relationship between PTSD and HRV in the context of co-occurring AUD.

Heart rate variability: Pre-deployment predictor of post-deployment PTSD symptoms.

Heart rate variability is a physiological measure associated with autonomic nervous system activity. This study hypothesized that lower pre-deployment HRV would be associated with higher post-deployment post-traumatic stress disorder (PTSD) symptoms. Three-hundred-forty-three Army National Guard soldiers enrolled in the Warriors Achieving Resilience (WAR) study were analyzed. The primary outcome was PTSD symptom severity using the PTSD Checklist - Military version (PCL) measured at baseline, 3- and 12-month post-deployment. Heart rate variability predictor variables included: high frequency power (HF) and standard deviation of the normal cardiac inter-beat interval (SDNN). Generalized linear mixed models revealed that the pre-deployment PCL*ln(HF) interaction term was significant (p<0.0001). Pre-deployment SDNN was not a significant predictor of post-deployment PCL. Covariates included age, pre-deployment PCL, race/ethnicity, marital status, tobacco use, childhood abuse, pre-deployment traumatic brain injury, and previous combat zone deployment. Pre-deployment heart rate variability predicts post-deployment PTSD symptoms in the context of higher pre-deployment PCL scores.

An exploratory analysis of the utility of adding cardiorespiratory biofeedback in the standard care of pregnancy-induced hypertension.

This study examined the efficacy of a cardiorespiratory biofeedback intervention compared to bed rest in the treatment of 47 women diagnosed with pregnancy-induced hypertension (PIH). The investigation consisted of a historical control group with 31 PIH subjects receiving treatment as usual (TAU), bed rest and antihypertensive medications, and an experimental group with 16 PIH subjects receiving TAU and instruction on using a portable respiratory sinus arrhythmia (RSA) biofeedback device once daily until delivery. Results indicated that systolic and diastolic blood pressure levels were unchanged for either group. Failing to find the intended main effects, a series of exploratory analyses were performed. Findings of associated hypotheses revealed that the RSA BF group had a 35 % higher birth weight than the TAU group. The gestational age at delivery was 10 % greater in the RSA BF group than in the TAU group. A significant relationship was found between the StressEraser Total and the 1-min Apgar score. Eighty-one percent of the subjects stated that the device was relaxing. Fifty percent of the subjects believed that the device helped them fall asleep. Overall, these results suggest that portable RSA biofeedback may be effective in reducing stress during pregnancy and improving perinatal outcomes.

Nonpharmacologic treatment for fibromyalgia: patient education, cognitive-behavioral therapy, relaxation techniques, and complementary and alternative medicine.

Because of the dynamic and complex nature of chronic pain, successful treatment usually requires addressing behavioral, cognitive, and affective processes. Many adjunctive interventions have been implemented in fibromyalgia (FM) treatment, but few are supported by controlled trials. Herein, some of the more commonly used nonpharmacologic interventions for FM are described and the evidence for efficacy is presented. Clinical observations and suggestions are also offered, including using the principles outlined in the acronym ExPRESS to organize a comprehensive nonpharmacologic pain management approach.

The effects of respiratory sinus arrhythmia biofeedback on heart rate variability and posttraumatic stress disorder symptoms: a pilot study.

Recent studies have found a significant association between PTSD and low heart rate variability (HRV), a biomarker of autonomic dysregulation. Research indicates that respiratory sinus arrhythmia (RSA) biofeedback increases HRV while reducing related pathological symptoms. This controlled pilot study compared RSA biofeedback to progressive muscle relaxation (PMR) as adjunctive interventions for 38 persons with PTSD symptoms in a residential treatment facility for a substance use disorder. Both groups were assessed at pre-intervention and 4-week post-intervention. Group x time interactions revealed significantly greater reductions in depressive symptoms and increases in HRV indices for the RSA group. Both groups significantly reduced PTSD and insomnia symptoms and a statistical trend was observed for reduced substance craving for the RSA group. Increases in HRV were significantly associated with PTSD symptom reduction. Overall, these results provide preliminary support for the efficacy of RSA biofeedback in improving physiological and psychological health for individuals with PTSD.

The effect of biofeedback on function in patients with heart failure.

Decreased HRV has been consistently associated with increased cardiac mortality and morbidity in HF patients. The aim of this study is to determine if a 6-week course of heart rate variability (HRV) biofeedback and breathing retraining could increase exercise tolerance, HRV, and quality of life in patients with New York Heart Association Class I-III heart failure (HF). Participants (N = 29) were randomly assigned to either the treatment group consisting of six sessions of breathing retraining, HRV biofeedback and daily practice, or the comparison group consisting of six sessions of quasi-false alpha-theta biofeedback and daily practice. Exercise tolerance, measured by the 6-min walk test (6MWT), HRV, measured by the standard deviation of normal of normal beats (SDNN), and quality of life, measured by the Minnesota Living with Congestive Heart Failure Questionnaire, were measured baseline (week 0), post (week 6), and follow-up (week 18). Cardiorespiratory biofeedback significantly increased exercise tolerance (p = .05) for the treatment group in the high (>or=31%) left ventricular ejection fraction (LVEF) category between baseline and follow-up. Neither a significant difference in SDNN (p = .09) nor quality of life (p = .08), was found between baseline and follow-up. A combination of HRV biofeedback and breathing retraining may improve exercise tolerance in patients with HF with an LVEF of 31% or higher. Because exercise tolerance is considered a strong prognostic indicator, cardiorespiratory biofeedback has the potential to improve cardiac mortality and morbidity in HF patients.

Efficacy of biofeedback-based treatments for temporomandibular disorders.

Bibliographic searches identified 14 controlled and uncontrolled outcome evaluations of biofeedback-based treatments for temporomandibular disorders published since 1978. This literature includes two randomized controlled trials (RCTs) of each of three types of biofeedback treatment: (1) surface electromyographic (SEMG) training of the masticatory muscles, (2) SEMG training combined with adjunctive cognitive-behavioral therapy (CBT) techniques, and (3) biofeedback-assisted relaxation training (BART). A detailed review of these six RCTs, supplemented with information from non-RCT findings, was conducted to determine the extent to which each type of intervention met treatment efficacy criteria promulgated by the Association for Applied Psychophysiology and Biofeedback (AAPB). We conclude that SEMG training with adjunctive CBT is an efficacious treatment for temporomandibular disorders and that both SEMG training as the sole intervention and BART are probably efficacious treatments. We discuss guidelines for designing and reporting research in this area and suggest possible directions for future studies.

Biofeedback treatment increases heart rate variability in patients with known coronary artery disease.

OBJECTIVES: To determine if cardiorespiratory biofeedback increases heart rate variability (HRV) in patients with documented coronary artery disease (CAD). BACKGROUND: Diminished HRV has been associated with increased cardiac morbidity and mortality. Evidence suggests that various lifestyle changes and pharmacologic therapies can improve HRV. The objective of this study was to determine if biofeedback increases HRV in patients with CAD. METHODS: Patients with established CAD (n = 63; mean age, 67 years) were randomly assigned to conventional therapy or to 6 biofeedback sessions consisting of abdominal breath training, heart and respiratory physiologic feedback, and daily breathing practice. HRV was measured by the standard deviation of normal-to-normal QRS complexes (SDNN) at week 1 (pretreatment), week 6 (after treatment), and week 18 (follow-up). RESULTS: Baseline characteristics were similar for the treatment and control groups. The SDNN for the biofeedback and control groups did not differ at baseline or at week 6 but were significantly different at week 18. The biofeedback group showed a significant increase in SDNN from baseline to week 6 (P <.001) and to week 18 (P =.003). The control subjects had no change from baseline to week 6 (P =.214) and week 18 (P =.27). CONCLUSIONS: Biofeedback increases HRV in patients with CAD and therefore may be an integral tool for improving cardiac morbidity and mortality rates.

The contribution of pain, reported sleep quality, and depressive symptoms to fatigue in fibromyalgia.

The major objective of this research was to evaluate the predictors of fatigue in patients with fibromyalgia (FM), using cross-sectional and daily assessment methodologies. In the cross-sectional phase of the research involving a sample of 105 FM patients, greater depression and lower sleep quality were concurrently associated with higher fatigue. While pain was correlated with fatigue, it did not independently contribute to fatigue in the regression equation. For a subset of patients from the cross-sectional sample (n=63) who participated in a week of prospective daily assessment of their pain, sleep quality, and fatigue, multiple regression analysis of aggregated (averaged) daily scores revealed that previous day's pain and sleep quality predicted next day's fatigue. Depression from the cross-sectional phase was not related to aggregated daily fatigue scores. A path analytic framework was tested with disaggregated (removing between subjects variability) data in which pain was predicted to contribute to lower sleep quality which, in turn, was predicted to lead to greater fatigue. The results revealed that poor sleep quality fully accounted for the positive relationship between pain and fatigue, thus substantiating the mediational role of sleep quality. The findings are indicative of a dysfunctional, cyclical pattern of heightened pain and non-restful sleep underlying the experience of fatigue in FM.