[Impact of biofeedback therapy on patients with fecal incontinence or constipation in a gastrointestinal neurophysiology unit in Bogotá, D.C.] / Impacto de la terapia de biorretroalimentación en pacientes con incontinencia fecal o constipación en una unidad de neurofisiología gastrointestinal en Bogotá, D.C.

INTRODUCTION: Treatment of functional disorders of the anorectal unit should focus on the underlying cause. Biofeedback therapy is a functional retraining of the pelvic floor that has proven useful in the treatment of constipation associated with dyssynergia and in the management of fecal incontinence. This study describes the first experiences with this form of biofeedback therapy in Colombia. OBJECTIVE: Describe our experience with biofeedback therapy in the gastrointestinal neurophysiology unit. MATERIALS AND METHODS: This historical cohort included patients with an indication for biofeedback therapy for constipation or fecal incontinence in the gastrointestinal neurophysiology unit during the data collection period. The response to therapy is described by comparing manometricfindings before and after 10 biofeedback sessions. RESULTS: 21 patients were included(71.4% women, the average age was 68, 9 with constipation and 12 with fecal incontinence.Among the patients with constipation there was a significant improvement in 71.4% of those who had rectal hyposensitivity and in 57.1% of those with dyssynergia. Biofeedback therapysignificantly increased the balloon expulsion rate (11.1 vs. 66.7%, p=0.02). In patients with fecal incontinence, there was improvement in 50% of those who had anal hypotonia and in 80% of those who had anal hyposensitivity. CONCLUSIONS: This study demonstrates that biofeedback therapy has a favorable impact on a high number of patients with constipationand fecal incontinence; in our center, the response is similar to that of the world literature.

Evaluation of the impact of overlapping upper gastrointestinal symptoms on the clinical characteristics of patients with functional constipation, along with risk factor analysis.

OBJECTIVES: Functional constipation (FC), a common functional gastrointestinal disorder, is usually overlapping with upper gastrointestinal symptoms (UGS). We aimed to explore the clinical characteristics of patients with FC overlapping UGS along with the related risk factors. METHODS: The differences in the severity of constipation symptoms, psychological state, quality of life (QoL), anorectal motility and perception function, autonomic function, and the effect of biofeedback therapy (BFT) among patients with FC in different groups were analyzed, along with the risk factors of overlapping UGS. RESULTS: Compared with patients with FC alone, those with FC overlapping UGS had higher scores in the Patient Assessment of Constipation Symptoms and Self-Rating Anxiety Scale and lower scores in the Short Form-36 health survey (P < 0.05). Patients with FC overlapping UGS also had lower rectal propulsion, more negative autonomic nervous function, and worse BFT efficacy (P < 0.05). Overlapping UGS, especially overlapping functional dyspepsia, considerably affected the severity of FC. Logistic regression model showed that age, body mass index (BMI), anxiety, exercise, and sleep quality were independent factors influencing overlapping UGS in patients with FC. CONCLUSIONS: Overlapping UGS reduces the physical and mental health and the QoL of patients with FC. It also increases the difficulty in the treatment of FC. Patient's age, BMI, anxiety, physical exercise, and sleep quality might be predictors for FC overlapping UGS.

Electromyographic biofeedback training in a cerebral palsy patient undergoing pronator teres rerouting and brachioradialis to extensor carpi radialis brevis tendon transfer surgery: A case report.

Several surgical procedures are used to treat dynamic pronation position of the forearm and flexion deformity of the wrist in cerebral palsy. Postoperative results of pronator teres rerouting were explored, while specially designed postoperative physiotherapy and its outcomes were limited. Herein, we present a case in whom the outcomes of electromyographic biofeedback (EMG-BF) training were assessed after pronator teres rerouting and brachioradialis tendon to extensor carpi radialis brevis tendon transfer combined with derotation osteotomy. The peak value increased, while the resting value decreased for the muscles after the intervention. Range of motion, hand function, manual ability, functional independence, and quality of life levels were improved. In conclusion, EMG biofeedback training may have a positive effect on neuromuscular control of pronator teres and brachioradialis. Free use of the upper extremity and improved manual ability positively affect the activity and quality of life of the patients.

Remote Short Sessions of Heart Rate Variability Biofeedback Monitored With Wearable Technology: Open-Label Prospective Feasibility Study.

BACKGROUND: Heart rate variability (HRV) biofeedback is often performed with structured education, laboratory-based assessments, and practice sessions. It has been shown to improve psychological and physiological function across populations. However, a means to remotely use and monitor this approach would allow for wider use of this technique. Advancements in wearable and digital technology present an opportunity for the widespread application of this approach. OBJECTIVE: The primary aim of the study was to determine the feasibility of fully remote, self-administered short sessions of HRV-directed biofeedback in a diverse population of health care workers (HCWs). The secondary aim was to determine whether a fully remote, HRV-directed biofeedback intervention significantly alters longitudinal HRV over the intervention period, as monitored by wearable devices. The tertiary aim was to estimate the impact of this intervention on metrics of psychological well-being. METHODS: To determine whether remotely implemented short sessions of HRV biofeedback can improve autonomic metrics and psychological well-being, we enrolled HCWs across 7 hospitals in New York City in the United States. They downloaded our study app, watched brief educational videos about HRV biofeedback, and used a well-studied HRV biofeedback program remotely through their smartphone. HRV biofeedback sessions were used for 5 minutes per day for 5 weeks. HCWs were then followed for 12 weeks after the intervention period. Psychological measures were obtained over the study period, and they wore an Apple Watch for at least 7 weeks to monitor the circadian features of HRV. RESULTS: In total, 127 HCWs were enrolled in the study. Overall, only 21 (16.5%) were at least 50% compliant with the HRV biofeedback intervention, representing a small portion of the total sample. This demonstrates that this study design does not feasibly result in adequate rates of compliance with the intervention. Numerical improvement in psychological metrics was observed over the 17-week study period, although it did not reach statistical significance (all P>.05). Using a mixed effect cosinor model, the mean midline-estimating statistic of rhythm (MESOR) of the circadian pattern of the SD of the interbeat interval of normal sinus beats (SDNN), an HRV metric, was observed to increase over the first 4 weeks of the biofeedback intervention in HCWs who were at least 50% compliant. CONCLUSIONS: In conclusion, we found that using brief remote HRV biofeedback sessions and monitoring its physiological effect using wearable devices, in the manner that the study was conducted, was not feasible. This is considering the low compliance rates with the study intervention. We found that remote short sessions of HRV biofeedback demonstrate potential promise in improving autonomic nervous function and warrant further study. Wearable devices can monitor the physiological effects of psychological interventions.

Visual feedback improves propulsive force generation during treadmill walking in people with Parkinson disease.

Persons with Parkinson's disease experience gait alterations, such as reduced step length. Gait dysfunction is a significant research priority as the current treatments targeting gait impairment are limited. This study aimed to investigate the effects of visual biofeedback on propulsive force during treadmill walking in persons with Parkinson's. Sixteen ambulatory persons with Parkinson's participated in the study. They received real-time biofeedback of anterior ground reaction force during treadmill walking at a constant speed. Peak propulsive force values were measured and normalized to body weight. Spatiotemporal parameters were also assessed, including stride length and double support percent. Persons with Parkinson's significantly increased peak propulsive force during biofeedback compared to baseline (p <.0001, Cohen's dz = 1.69). Variability in peak anterior ground reaction force decreased across repeated trials (p <.0001, dz = 1.51). While spatiotemporal parameters did not show significant changes individually, stride length and double support percent improved marginally during biofeedback trials. Persons with Parkinson's can increase propulsive force with visual biofeedback, suggesting the presence of a propulsive reserve. Though stride length did not significantly change, clinically meaningful improvements were observed. Targeting push-off force through visual biofeedback may offer a potential rehabilitation technique to enhance gait performance in Persons with Parkinson's. Future studies could explore the long-term efficacy of this intervention and investigate additional strategies to improve gait in Parkinson's disease.

Learning effects in over-ground running gait retraining: A six-month follow-up of a quasi-randomized controlled trial.

This study evaluated learning and recall effects following a feedback-based retraining program. A 6-month follow-up of a quasi-randomized controlled trial was performed with and without recall. Twenty runners were assigned to experimental or control groups and completed a 3-week running program. A body-worn system collected axial tibial acceleration and provided real-time feedback on peak tibial acceleration for six running sessions in an athletic training facility. The experimental group received music-based biofeedback in a faded feedback scheme. The controls received tempo-synchronized music as a placebo for blinding purposes. The peak tibial acceleration and vertical loading rate of the ground reaction force were determined in a lab at baseline and six months following the intervention to assess retention and recall. The impacts of the experimental group substantially decreased at follow-up following a simple verbal recall (i.e., run as at the end of the program): peak tibial acceleration:-32%, p = 0.018; vertical loading rate:-34%, p = 0.006. No statistically significant changes were found regarding the retention of the impact variables. The impact magnitudes did not change over time in the control group. The biofeedback-based intervention did not induce clear learning at follow-up, however, a substantial impact reduction was recallable through simple cueing in the absence of biofeedback.

Efficacy and safety of solifenacin combined with biofeedback in children with overactive bladder.

BACKGROUND: Overactive bladder is a common chronic urological disorder in children, liable to impact normal social activities, disrupt sleep and even impair self-esteem. We aimed to evaluate the efficacy and safety of solifenacin combined with biofeedback for paediatric overactive bladder. METHOD: Forty-five children with overactive bladder were enrolled and divided into three groups: 15 patients in Group A were treated with solifenacin, 15 cases in Group B with biofeedback, and the other 15 patients in Group C with the combination of solifenacin plus biofeedback. Each group was subdivided into the non-urge incontinence (non-UI) and urge incontinence (UI) groups. The remission rates were compared among the three groups at 2, 4, 8 and 12 weeks from the beginning of treatment. The side effects of solifenacin were recorded and followed up. RESULT: After 2 weeks since initial treatment, the complete response rates were 33.3% (5/15), 20.0% (3/15), and 53.3% (8/15) in the three groups. At 4 weeks, the complete remission rates were 46.7% (7/15), 33.3% (5/15), and 60.0% (9/15) respectively. Moreover, the complete remission rates of the UI groups were higher than the non-UI groups (p < 0.05). At 8 weeks, the complete response rates were 53.3% (8/15), 40.0% (6/15), and 67.7% (10/15). At 12 weeks, the complete response rates were 67.8% (10/15), 60.0% (9/15), and 86.7% (13/15). The complete response rates were higher and urodynamic parameters were improved obviously in group C than the other two groups (p < 0.05) during the follow-ups. The median voiding frequency decreased and median functional bladder capacity increased obviously in Group C after 4 weeks (p < 0.05). Dry mouth was observed in 2 patients (4.4%). 2 patients experienced constipation (4.4%), and neither case was severe. The symptoms of these four patients had relieved by reducing the dose of solifenacin. CONCLUSION: Solifenacin combined with biofeedback had good efficacy and compliance for children experiencing overactive bladder. It took only 2 weeks to achieve the complete response rate over 50%, especially for the improvement of UI symptoms.

Pelvic floor muscle contraction automatic evaluation algorithm for pelvic floor muscle training biofeedback using self-performed ultrasound.

INTRODUCTION: Non-invasive biofeedback of pelvic floor muscle training (PFMT) is required for continuous training in home care. Therefore, we considered self-performed ultrasound (US) in adult women with a handheld US device applied to the bladder. However, US images are difficult to read and require assistance when using US at home. In this study, we aimed to develop an algorithm for the automatic evaluation of pelvic floor muscle (PFM) contraction using self-performed bladder US videos to verify whether it is possible to automatically determine PFM contraction from US videos. METHODS: Women aged ≥ 20 years were recruited from the outpatient Urology and Gynecology departments of a general hospital or through snowball sampling. The researcher supported the participants in their self-performed bladder US and videos were obtained several times during PFMT. The US videos obtained were used to develop an automatic evaluation algorithm. Supervised machine learning was then performed using expert PFM contraction classifications as ground truth data. Time-series features were generated from the x- and y-coordinate values of the bladder area including the bladder base. The final model was evaluated for accuracy, area under the curve (AUC), recall, precision, and F1. The contribution of each feature variable to the classification ability of the model was estimated. RESULTS: The 1144 videos obtained from 56 participants were analyzed. We split the data into training and test sets with 7894 time series features. A light gradient boosting machine model (Light GBM) was selected, and the final model resulted in an accuracy of 0.73, AUC = 0.91, recall = 0.66, precision = 0.73, and F1 = 0.73. Movement of the y-coordinate of the bladder base was shown as the most important. CONCLUSION: This study showed that automated classification of PFM contraction from self-performed US videos is possible with high accuracy.

A Preliminary Study of Voluntary Cough Motor Performance and Learning With Skill Training and Biofeedback.

PURPOSE: Sensorimotor cough skill training (CST) has been shown to improve cough strength, as well as facilitate changes during training (i.e., motor performance) and generalization to untrained tasks (i.e., motor learning). However, there is a gap in our understanding of the effects of voluntary CST (without sensory stimuli) on motor performance and learning. Furthermore, the contribution of physiologic factors, such as lung volume, a driver of cough strength in healthy adults, and treatment-specific factors, such as biofeedback, remains unexamined. METHOD: Twenty individuals with Parkinson's disease (PD) completed pre- and post-CST single voluntary, sequential voluntary, and reflex cough testing. Participants were randomized to biofeedback or no biofeedback groups. They completed one CST session involving 25 trials of voluntary coughs, with the treatment target set 25% above baseline peak flow. Participants were instructed to "cough hard" to exceed the target. In the biofeedback group, participants received direct visualization of the target line in real time. RESULTS: Cough peak flow showed positive improvements in motor performance (ß = .02; 95% credible interval [CI]: 0.01, 0.03) and learning (ß = .26; 95% CI: 0.03, 0.47). Changes in lung volume from pre- to post-CST did not predict treatment response. No differences in treatment response were detected between the biofeedback groups. CONCLUSIONS: A single session of voluntary CST improved voluntary cough motor performance and learning. Although lung volume increased during CST, changes to lung volume did not predict treatment response. These findings demonstrate the potential of voluntary CST to improve motor performance and motor learning among individuals with PD and cough dysfunction. SUPPLEMENTAL MATERIAL AND OPEN SCIENCE FORM: https://doi.org/10.23641/asha.25447444.

Real-time heart rate variability biofeedback amplitude during a large-scale digital mental health intervention differed by age, gender, and mental and physical health.

Heart rate variability biofeedback (HRVB) is an efficacious treatment for depression and anxiety. However, translation to digital mental health interventions (DMHI) requires computing and providing real-time HRVB metrics in a personalized and user-friendly fashion. To address these gaps, this study validates a real-time HRVB feedback algorithm and characterizes the association of the main algorithmic summary metric-HRVB amplitude-with demographic, psychological, and health factors. We analyzed HRVB data from 5158 participants in a therapist-supported DMHI incorporating slow-paced breathing to treat depression or anxiety symptoms. A real-time feedback metric of HRVB amplitude and a gold-standard research metric of low-frequency (LF) power were computed for each session and then averaged within-participants over 2 weeks. We provide HRVB amplitude values, stratified by age and gender, and we characterize the multivariate associations of HRVB amplitude with demographic, psychological, and health factors. Real-time HRVB amplitude correlated strongly (r = .93, p < .001) with the LF power around the respiratory frequency (~0.1 Hz). Age was associated with a significant decline in HRVB (ß = -0.46, p < .001), which was steeper among men than women, adjusting for demographic, psychological, and health factors. Resting high- and low-frequency power, body mass index, hypertension, Asian race, depression symptoms, and trauma history were significantly associated with HRVB amplitude in multivariate analyses (p's < .01). Real-time HRVB amplitude correlates highly with a research gold-standard spectral metric, enabling automated biofeedback delivery as a potential treatment component of DMHIs. Moreover, we identify demographic, psychological, and health factors relevant to building an equitable, accurate, and personalized biofeedback user experience.

A Biofeedback Based Virtual Reality Game for Pediatric Population (BioVirtualPed): A Feasibility Trial.

OBJECTIVE: This trial aims to assess the acceptability, feasibility, and safety of BioVirtualPed, a biofeedback-based virtual reality (VR) game designed to reduce pain, anxiety, and fear in children undergoing medical procedures. METHODS: An Oculus Quest 2 headset was used in the VR experience, respiratory data was captured using an ADXL354 accelerometer, and these data were integrated into the game with ArdunioUno software. The sample of this study consisted of 15 pediatric oncology patients aged 6 to 12 years between July and August 2023. BioVirtualPed's acceptability, feasibility, and safety were evaluated through child and expert feedback, alongside metrics including the System Usability Scale, Wong-Baker Pain Rating Scale, Child Fear Scale, Child Anxiety Scale-Status, Satisfaction Scoring, and various feasibility and safety parameters. RESULTS: Regarding the acceptability, the expert evaluation showed a mean score of 122.5 ± 3.53, indicating high usability for the system. All children provided positive feedback, and both children and their mothers reported high satisfaction with using BioVirtualPed. The BioVirtualPed was feasible for reducing children's pain, fear, and anxiety levels. All the children complied with the game, and no one withdrew from the trial. BioVirtualPed did not cause symptoms of dizziness, vomiting, or nausea in children and was found to be safe for children. CONCLUSION: The findings showed that BioVirtualPed meets the following criteria: feasibility, user satisfaction, acceptability, and safety. It is a valuable tool to improve children's experience undergoing port catheter needle insertion procedures. IMPLICATION FOR NURSING PRACTICE: Integration of VR interventions with BioVirtualPed into routine nursing care practices has the potential to effectively manage the pain, anxiety, and fear experienced by children undergoing medical procedures. The safety, feasibility, and acceptability results are promising for further research and integration into pediatric healthcare practice.

Effect of sensor location for modifying center of pressure during gait using haptic feedback in people with chronic ankle instability.

BACKGROUND: Gait retraining using haptic biofeedback medially shifts the center of pressure (COP) while walking in orthopedic populations. However, the ideal sensor location needed to effectively shift COP medially has not been identified in people with chronic ankle instability (CAI). RESEARCH QUESTIONS: Can a heel sensor location feasibly be employed in people with CAI without negatively altering kinematics? Does a heel sensor placement relative to the 5th metatarsal head (5MH) impact COP location while walking in people with CAI? METHODS: In this exploratory crossover study, 10 participants with CAI walked on a treadmill with vibration feedback for 10 minutes with a plantar pressure sensor under the heel and 5MH. Separate 2×2 repeated measures analyses of covariances (rmANCOVAs) were used to compare the averaged COP location and 3-D lower extremity kinematics from the first 10% of stance before and after training and between sensor locations. Baseline measures served as covariates to adjust for baseline differences. RESULTS: Feedback triggered by a heel sensor resulted in 40% of participants avoiding a heel strike. There were no significant main effects or interactions between time and sensor location on COP location when controlling for baseline COP (p>0.05). However, with the 5MH placement, participants displayed less ankle internal rotation(IR) (5MH/Heel: -4.12±0.00º/ -6.43±0.62º), less forefoot abduction (-4.29±0.00º/ -5.14±1.01º), more knee flexion (3.40±0.32º/ 0.14±0.57º), less knee external rotation (-10.95±0.00º/-11.24±1.48º), less hip extension (-0.20±0.00º/-1.42±1.05º), and less hip external rotation (3.12±0.00º/3.75±1.98º). SIGNIFICANCE: A 5MH location may be more feasible based on difficulties maintaining heel strike when the sensor was under the heel. While no sensor location was statistically better at changing the COP, the 5MH location decreased proximal transverse plane motions making participants' gait more like controls. Individual response variations support comprehensive lower extremity assessments and the need to identify responder profiles using sensory feedback in people with CAI.

Acupuncture Versus Biofeedback for Treatment of Functional Anorectal Pain.

BACKGROUND/AIMS: Functional anorectal pain is one of several types of functional anorectal disorders. In this study, we compared the effectiveness of acupuncture (intervention) and biofeedback (control) as treatment for patients with functional anorectal pain. MATERIALS AND METHODS: This prospective, single-center, randomized, and comparative study examined 68 patients with functional anorectal pain who were recruited from June 2017 to January 2019 at the Nanjing Hospital of Chinese Medicine Affiliated to Nanjing University of Chinese Medicine. Patients were randomly assigned to receive acupuncture or biofeedback. Patients in the acupuncture group received acupuncture at Zhongliao (BL33), Xialiao (BL34), Ganshu (BL18), Shenshu (BL23), and Dachangshu (BL25). Patients in the biofeedback group received pelvic floor biofeedback therapy, consisting of Kegel pelvic floor muscle training and electrical stimulation. Patients in both groups received 20 treatments over 4 weeks. The primary outcome was pain score on a visual analog scale, and the secondary outcomes were results from the MOS 36-item short-form health survey (SF-36) quality of life questionnaire, the self-rating depression scale, and the self-rating anxiety scale. RESULTS: Visual analog scale pain scores significantly decreased in both of the groups with treatment (both P < .01). The final visual analog scale score was significantly lower in patients with pelvic floor dyssynergia who were treated with biofeedback (1.40 ± 0.97 vs. 5.30 ± 1.70) (P < .05). The 2 groups had similar decreases in self-rating depression scale and self-rating anxiety scale scores. Intriguingly, the acupuncture group had better mental health outcomes (P <.05). CONCLUSION: Both acupuncture and biofeedback therapy reduced the pain of patients with functional anorectal pain. Biofeedback provided more relief in patients with pelvic floor dyssynergia, and acupuncture provided greater improvements in mental health status.

An open trial of biofeedback for long COVID.

OBJECTIVE: Biofeedback is a therapeutic treatment model that teaches self-regulation of autonomic functions to alleviate stress-related symptoms. "Long COVID" refers to chronic physical and cognitive sequelae post-SARS-CoV-2 infection. This study examined the efficacy of a six-week intervention, consisting of weekly one-hour sessions combining heart rate variability and temperature biofeedback, for alleviating mood symptoms, somatic symptoms and sleep disturbance of patients diagnosed with long COVID. METHODS: Data were collected from 20 adult participants aged 22-63 (Mage = 44.1, SDage = 12.2) with varying long COVID symptoms. Within this single arm design, 16 of the 20 participants completed all six sessions of biofeedback; 14 completed an assessment at the three-month post-treatment time point. RESULTS: Participants self-reported significant improvements in somatic, anxiety, and depressive symptoms, sleep quality, quality of life, and number of "bad days" immediately after the intervention and three months later (Cohen's d effect size (ES) = 1.09-0.46). Reduced number of medical doctor visits (ES = 0.85) and prescription drug use over the last month (odds ratio = 0.33), as well as improved emotional wellbeing (ES = 0.97) were observed at the three-month time point only. CONCLUSION: Results suggest that this short, readily scalable intervention can be potentially efficacious in alleviating symptoms of long COVID. Despite notable improvements, the major limitation of this study is its lack of control group. While a randomized trial merits study, biofeedback appears to be a brief, effective, non-invasive, and low-cost treatment option for patients with chronic somatic symptoms secondary to SARS-CoV-2 infection. CLINICALTRIALS: govID: NCT05120648.

Effects of stress management interventions on heart rate variability in adults with cardiovascular disease: a systematic review and meta-analysis.

Meta-analysis was used to investigate the potential benefits of stress management interventions (SMIs) on vagally-mediated heart rate variability (HRV) in adults with cardiovascular disease. Electronic bibliographic databases were searched through August 2022. Randomized controlled trials and quasi-experimental studies assessing effects of SMIs on HRV were included. Methodological quality was assessed with a standardized checklist. A pooled effect size was calculated for vagally-mediated HRV indices (standard deviation of normal-to-normal intervals, root mean square of the successive differences, and high frequency power) using random effects models. Fourteen studies (1202 participants, Mage: 59 ± 6.25 years; 25% ± 16% women; 61% ± 22% White) were included. Ten studies (11 effects) reported short-term HRV assessment; a small between-group difference emerged for vagally-mediated HRV (d+ = .27, 95% confidence interval [CI] 0.01-0.52, k = 11). Most interventions examined biofeedback; these studies yielded a small between-group difference on vagally-mediated HRV (d+ = 0.31, 95% CI 0.09-0.53, k = 7, Q [6] = 3.82, p = .70, I2 = 11%). This is the first systematic examination of the effect of SMIs on HRV in adults with CVD. Findings suggest a small effect of SMIs on vagally-mediated HRV, with biofeedback likely driving the effect. More research is required to fully understand whether this benefit on vagally-mediated HRV applies to other SMIs.

Smoking cessation in pregnant women: A randomized controlled trial investigating the effectiveness of an eHealth intervention including heart rate variability-biofeedback training.

BACKGROUND: Prenatal smoking and stress are associated with adverse health effects for women themselves and are risk factors for adverse outcomes of the child. Effective interventions are needed to support women with smoking cessation and reducing stress. The aims were (1) to test the effectiveness of an 8-week eHealth intervention targeting stress reduction and smoking cessation; (2) to examine whether stress reduction mediated the intervention effect on smoking behavior; (3) to test motivation to quit as a moderator; and (4) to investigate a dose-response effect of program usage. METHODS: Pregnant women were included if they were >18 years of age, < 28 weeks pregnant at recruitment, and currently smoking. In total, 156 consenting participants were randomly assigned to the intervention or active control condition. Study outcomes on smoking (yes/no, frequency, and quantity) were collected via online questionnaires at pre-intervention (baseline; t0), post-intervention (8 weeks after t0; t1), and follow up at two weeks (t2) and three months (t3) after birth. RESULTS: Smoking and stress reduced over the 8-week period in both conditions. The intervention effect on smoking was not mediated by stress reduction. Motivation to quit was found to moderate the intervention effect (smoking frequency and quantity) and a dose-response effect was found for program usage in the intervention for the reduction on smoking frequency and quantity. CONCLUSION: Program usage and motivation to quit are important for smoking reduction in pregnant women. Further research is needed to examine how the intervention could be improved to increase treatment effectiveness.

Heart rate and breathing effects on attention and memory (HeartBEAM): study protocol for a randomized controlled trial in older adults.

BACKGROUND: In healthy people, the "fight-or-flight" sympathetic system is counterbalanced by the "rest-and-digest" parasympathetic system. As we grow older, the parasympathetic system declines as the sympathetic system becomes hyperactive. In our prior heart rate variability biofeedback and emotion regulation (HRV-ER) clinical trial, we found that increasing parasympathetic activity through daily practice of slow-paced breathing significantly decreased plasma amyloid-ß (Aß) in healthy younger and older adults. In healthy adults, higher plasma Aß is associated with greater risk of Alzheimer's disease (AD). Our primary goal of this trial is to reproduce and extend our initial findings regarding effects of slow-paced breathing on Aß. Our secondary objectives are to examine the effects of daily slow-paced breathing on brain structure and the rate of learning. METHODS: Adults aged 50-70 have been randomized to practice one of two breathing protocols twice daily for 9 weeks: (1) "slow-paced breathing condition" involving daily cognitive training followed by slow-paced breathing designed to maximize heart rate oscillations or (2) "random-paced breathing condition" involving daily cognitive training followed by random-paced breathing to avoid increasing heart rate oscillations. The primary outcomes are plasma Aß40 and Aß42 levels and plasma Aß42/40 ratio. The secondary outcomes are brain perivascular space volume, hippocampal volume, and learning rates measured by cognitive training performance. Other pre-registered outcomes include plasma pTau-181/tTau ratio and urine Aß42. Recruitment began in January 2023. Interventions are ongoing and will be completed by the end of 2023. DISCUSSION: Our HRV-ER trial was groundbreaking in demonstrating that a behavioral intervention can reduce plasma Aß levels relative to a randomized control group. We aim to reproduce these findings while testing effects on brain clearance pathways and cognition. TRIAL REGISTRATION: ClinicalTrials.gov NCT05602220. Registered on January 12, 2023.

Pre-Implementation Analysis of the Usability and Acceptability of a Poststroke Complex Telehealth Biofeedback Intervention.

IMPORTANCE: Complex telehealth interventions can facilitate remote occupational therapy services and improve access for people living with chronic neurological conditions. Understanding the factors that influence the uptake of these technologies is important. OBJECTIVE: To explore the fit between electromyography (EMG) biofeedback and telerehabilitation for stroke survivors, optimize EMG biofeedback interventions, and, more broadly, support other efforts to develop complex telerehabilitation interventions. DESIGN: Pre-implementation mixed-methods analysis of usability and acceptability data collected during a pilot and feasibility study. SETTING: Community. PARTICIPANTS: Adult stroke survivors with hemiparesis (N = 11; M age = 54 yr). INTERVENTION: Game-based EMG biofeedback system for arm sensorimotor rehabilitation, delivered via telehealth. OUTCOMES AND MEASURES: Post-Study System Usability Questionnaire, an extended Unified Theory of Acceptance and Use of Technology model questionnaire, and semistructured interview. We coded the interview data using questionnaire constructs. RESULTS: Participants used an EMG biofeedback intervention at home. Quantitative measures show high levels of perceived usability and acceptability, supported by qualitative findings describing specific facilitators and barriers. CONCLUSIONS AND RELEVANCE: Pre-implementation studies can improve the design and relevance of complex telehealth interventions. One major conclusion from this study is the influence of therapy providers on acceptability and usability of complex telehealth interventions. Plain-Language Summary: This study contributes to an emerging body of literature that examines the use of complex telehealth interventions with survivors of neurological injury. The findings highlight the value and support the development and use of complex telehealth interventions, which have the potential to improve remote access to occupational therapy for clients living with chronic neurological conditions. Complex telehealth interventions can open doors for survivors of neurological injury who face barriers to accessing occupational therapy and would benefit from technology-enabled therapy at home.

Biobehavioral treatments of migraine.

Pharmacotherapies are the mainstays of migraine management, though it is not uncommon for them to be poorly tolerated, contraindicated, or only modestly effective. There is a clear need for nonpharmacologic migraine therapies, either employed alone or in combination with pharmacotherapies. Behavioral and psychosocial factors known to contribute to the onset, exacerbation, and persistence of primary headache disorders (e.g., stress, sleep, diet) serve as targets within a self-management model for migraine-a model that features headache pharmacotherapies, behavioral skills training, medication adherence facilitation, relevant lifestyle changes, and techniques to limit headache-related impairment. Behavioral self-management interventions for migraine with the strongest empirical validation (e.g., relaxation training, biofeedback training, cognitive-behavior therapies) presently are available in specialty headache treatment centers and routinely show promise for reducing headache pain frequency/severity and related impairment, reducing reliance on pharmacotherapies, enhancing personal control over headache activity, and reducing headache-related distress and symptoms. These approaches may be particularly well-suited among patients for whom pharmacotherapies are unwanted, poorly tolerated, or contraindicated. Though underutilized, clinical trials indicate that new and well-established behavioral therapies are similarly effective to migraine medications for migraine prevention among adults and can be successfully employed in various settings.