Autonomic Modulation Training for Stress
(AMT Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJudith P Andersen, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Toronto
Disqualifiers: Non-canadian officers, Administrators, Civilians, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?
Police officers are exposed to hazardous, disturbing events that impose stress and long-term trauma. Upwards of 15-26% of public safety personnel (PSP) report one or more mental health symptoms. Accumulated stress and posttraumatic stress injuries (PTSI) result in chronic physical and mental health disorders including anxiety, depression, substance abuse, and cardiovascular disease. PTSI are related to reduced occupational performance, absenteeism, and risky behaviour, with implications for both police and public safety. Recent empirical evidence and government reports highlight a mental health and suicide crisis among various PSP sectors in Canada. Prior research forms an urgent call for evidence-based programs that build resilience and wellness capacity to prevent PTSI symptoms before they manifest as severe, chronic, diagnosable disorders. The current study addresses the limited effectiveness issues associated with existing interventions for PTSI among PSP and also considers sex and gender as central determinants of health. Advances in physiology and neuroscience demonstrate that resilience is maintained by the healthy functioning of psychophysiological systems within the body. Objective biological measures have shown that chronic stress and trauma disrupt both psychological and physiological functioning, eroding resilience and reducing wellness capacity. Traditional interventions to build resilience among PSP have not adequately addressed the physiological underpinnings that lead to mental and physical health conditions, as well as burnout and fatigue following trauma. Together with previous empirical research lead by the NPA, the current proposal addresses this gap in PSP intervention research by employing Autonomic Modulation Training (AMT), a biological approach to building resilience and wellness capacity among PSP exposed to PTSI. Prior research shows that core AMT techniques effectively reduce psychophysiological stress and mental health symptoms in clinical and non-clinical populations. Further, research has shown that AMT techniques improve police health and occupational performance when completed during scenario-based, in-person training. The aim of the proposed study is to test if a web-based delivery of AMT for police officers can build resilience and wellness capacity, and reduce symptoms of PTSI with similar effectiveness as in-person training. An additional novel scientific contribution of the current proposal includes an examination of sex and gender in baseline biological presentation of PTSI among police, and in response to a resilience building intervention.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators or your healthcare provider for guidance.
What data supports the effectiveness of the treatment Autonomic Modulation Training for stress?
Is Autonomic Modulation Training (AMT) safe for humans?
How is Autonomic Modulation Training (AMT) different from other stress treatments?
Autonomic Modulation Training (AMT) is unique because it uses non-invasive techniques like Peripheral Nerve Stimulation (PNS) to reduce stress by modulating the autonomic nervous system, which controls involuntary bodily functions. This approach is different from traditional stress management methods as it directly targets physiological stress responses, potentially offering a personalized and wearable-compatible solution for stress reduction.111121314
Eligibility Criteria
This trial is for active duty frontline law enforcement officers in Canada who speak English fluently. It's designed to help police officers build resilience and wellness capacity, potentially reducing symptoms of post-traumatic stress injuries (PTSI).Inclusion Criteria
You are currently working as a frontline law enforcement officer in Canada and not on extended medical or disability leave.
You need to be able to speak English well.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Participants complete baseline assessments to measure initial PTSI symptoms and resilience
1 week
Treatment
Participants in the experimental group undergo a 6-week Autonomic Modulation Training (AMT) intervention delivered online
6 weeks
Follow-up
Participants are monitored for changes in PTSI symptoms and resilience post-intervention
1 week
Control Group Wait-list
Control group participants wait for 7 weeks before taking the follow-up assessment and can then enroll in the AMT intervention
7 weeks
Treatment Details
Interventions
- Autonomic Modulation Training (Behavioral)
Trial OverviewThe study tests Autonomic Modulation Training (AMT), a web-based program aimed at improving resilience against stress and trauma. The effectiveness of AMT will be compared to traditional in-person training methods.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
Participants randomized to the experimental group will complete baseline assessments, the 6 week AMT treatment online and then complete the follow up assessment (8 weeks total)
Group II: ControlActive Control1 Intervention
Participants randomized to the control group will be matched to the experimental group on demographic and outcome measures. Control participants will take the baseline assessments, will wait 7 weeks and take the follow-up assessment (8 weeks total). Control group participants are able to enrol in the AMT intervention at the end of their wait-list control period.
Autonomic Modulation Training is already approved in Canada for the following indications:
🇨🇦 Approved in Canada as Autonomic Modulation Training for:
- Post-traumatic stress injuries (PTSI) prevention and treatment
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Toronto MississaugaMississauga, Canada
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Who Is Running the Clinical Trial?
University of TorontoLead Sponsor
Canadian Institutes of Health Research (CIHR)Collaborator
References
Transcutaneous auricular Vagus Nerve Stimulation and Median Nerve Stimulation reduce acute stress in young healthy adults: a single-blind sham-controlled crossover study. [2023]Stress is a major determinant of health and wellbeing. Conventional stress management approaches do not account for the daily-living acute changes in stress that affect quality of life. The combination of physiological monitoring and non-invasive Peripheral Nerve Stimulation (PNS) represents a promising technological approach to quantify stress-induced physiological manifestations and reduce stress during everyday life. This study aimed to evaluate the effectiveness of three well-established transcutaneous PNS modalities in reducing physiological manifestations of stress compared to a sham: auricular and cervical Vagus Nerve Stimulation (taVNS and tcVNS), and Median Nerve Stimulation (tMNS). Using a single-blind sham-controlled crossover study with four visits, we compared the stress mitigation effectiveness of taVNS, tcVNS, and tMNS, quantified through physiological markers derived from five physiological signals peripherally measured on 19 young healthy volunteers. Participants underwent three acute mental and physiological stressors while receiving stimulation. Blinding effectiveness was assessed via subjective survey. taVNS and tMNS relative to sham resulted in significant changes that suggest a reduction in sympathetic outflow following the acute stressors: Left Ventricular Ejection Time Index (LVETI) shortening (tMNS: p = 0.007, taVNS: p = 0.015) and Pre-Ejection Period (PEP)-to-LVET ratio (PEP/LVET) increase (tMNS: p = 0.044, taVNS: p = 0.029). tMNS relative to sham also reduced Pulse Pressure (PP; p = 0.032) and tonic EDA activity (tonicMean; p = 0.025). The nonsignificant blinding survey results suggest these effects were not influenced by placebo. taVNS and tMNS effectively reduced stress-induced sympathetic arousal in wearable-compatible physiological signals, motivating their future use in novel personalized stress therapies to improve quality of life.
Effects of autogenic training on stress response and heart rate variability in nursing students. [2016]This study was undertaken to confirm the effects of autogenic training (AT) on stress response and heart rate variability in nursing school students experiencing stress related to clinical training.
[Stability of mental stress-induced hemodynamic and autonomic reaction despite successful treatment for psychosomatic disorder]. [2016]Autonomic imbalance and exaggerated stress responses are associated with an increased risk of morbidity and mortality and have been associated with several psychosomatic disorders. Has in-patient psychotherapy any effect on autonomic regulation and mental stress reactivity? In 77 patients undergoing in-patient psychometric treatment psychometric examination and psychophysiological assessment of hemodynamic and autonomic parameters during rest and 2 mental stress tests was performed at the beginning and at the end of in-patient psychotherapy. Despite marked improvements in symptoms our short-term treatment for psychosomatic disorders did not affect autonomic and hemodynamic activation at rest or during stress testing. It remains to be investigated if increased physical activity and relaxation expected after improvement have beneficial physiological effects over longer time spans.
Vagal modulation of responses to mental challenge in posttraumatic stress disorder. [2019]Studies of the autonomic nervous system in posttraumatic stress syndrome (PTSD) have focused on the sympathetic modulation of arousal and have neglected the parasympathetic contribution. This study addresses the parasympathetic control of heart rate in individuals who have survived traumatic events.
Visceral responses to opposite types of autogenic-training imagery. [2019]The purpose of this experiment was to test whether suggestions of imagery of the type used in autogenic training have specific effects on autonomic responses. In order to control for the effort involved in imagery and to determine the specificity of the effect, opposite types of imagery were used: (a) hands warm and heavy, and (b) hands cool and light. Nine subjects were trained for six daily sessions. Within each day 16 stimulus presentations were made, equally balanced between the two types of imagery. Heart rate, respiration rate, and EEG in the alpha frequency were recorded throughout all sessions. The 'cool' instruction reliably increased heart rate and respiration above pre-stimulus baselines; the 'warm' instruction resulted in statistically insignificant changes in the opposite direction. Large, consistent individual differences in autonomic response were found.
Effect of autogenic training on cardiac autonomic nervous activity in high-risk fire service workers for posttraumatic stress disorder. [2015]We investigated the effect of autogenic training (AT) on cardiac autonomic nervous activity in fire services workers with the use of the questionnaire of the Japanese-language version of Impact of Event Scale-Revised (IES-R-J) and indexes of heart rate variability.
Behavioral neurocardiac training in hypertension: a randomized, controlled trial. [2022]It is not established whether behavioral interventions add benefit to pharmacological therapy for hypertension. We hypothesized that behavioral neurocardiac training (BNT) with heart rate variability biofeedback would reduce blood pressure further by modifying vagal heart rate modulation during reactivity and recovery from standardized cognitive tasks ("mental stress"). This randomized, controlled trial enrolled 65 patients with uncomplicated hypertension to BNT or active control (autogenic relaxation), with six 1-hour sessions over 2 months with home practice. Outcomes were analyzed with linear mixed models that adjusted for antihypertensive drugs. BNT reduced daytime and 24-hour systolic blood pressures (-2.4+/-0.9 mm Hg, P=0.009, and -2.1+/-0.9 mm Hg, P=0.03, respectively) and pulse pressures (-1.7+/-0.6 mm Hg, P=0.004, and -1.4+/-0.6 mm Hg, P=0.02, respectively). No effect was observed for controls (P>0.10 for all indices). BNT also increased RR-high-frequency power (0.15 to 0.40 Hz; P=0.01) and RR interval (P0.10). In contrast to relaxation therapy, BNT with heart rate variability biofeedback modestly lowers ambulatory blood pressure during wakefulness, and it augments tonic vagal heart rate modulation. It is unknown whether efficacy of this treatment can be improved with biofeedback of baroreflex gain. BNT, alone or as an adjunct to drug therapy, may represent a promising new intervention for hypertension.
Stress management at the worksite: reversal of symptoms profile and cardiovascular dysregulation. [2018]Work stress may increase cardiovascular risk either indirectly, by inducing unhealthy life styles, or directly, by affecting the autonomic nervous system and arterial pressure. We hypothesized that, before any apparent sign of disease, work-related stress is already accompanied by alterations of RR variability profile and that a simple onsite stress management program based on cognitive restructuring and relaxation training could reduce the level of stress symptoms, revert stress-related autonomic nervous system dysregulation, and lower arterial pressure. We compared 91 white-collar workers, enrolled at a time of work downsizing (hence, in a stress condition), with 79 healthy control subjects. Psychological profiles were assessed by questionnaires and autonomic nervous system regulation by spectral analysis of RR variability. We also tested a simple onsite stress management program (cognitive restructuring and relaxation training) in a subgroup of workers compared with a sham subgroup (sham program). Workers presented an elevated level of stress-related symptoms and an altered variability profile as compared with control subjects (low-frequency component of RR variability was, respectively, 65.2+/-2 versus 55.3+/-2 normalized units; P
Transcutaneous Auricular Vagus Nerve Stimulation Attenuates Early Increases in Heart Rate Associated With the Cold Pressor Test. [2023]Transcutaneous auricular vagus nerve stimulation (taVNS) may be useful in treating disorders characterized by chronic parasympathetic disinhibition. Acute taVNS decreases resting heart rate in healthy individuals, but little is known regarding the effects of taVNS on the cardiac response to an acute stressor. To investigate effects on the acute stress response, we investigated how taVNS affected heart rate changes during a cold pressor test (CPT), a validated stress induction technique that reliably elicits a sympathetic stress response with marked increases in heart rate, anxiety, stress, and pain.
A tale of two mechanisms: a meta-analytic approach toward understanding the autonomic basis of cardiovascular reactivity to acute psychological stress. [2014]A series of meta-analyses was undertaken to determine the contributions of sympathetic and parasympathetic activation to cardiovascular stress reactivity. A literature search yielded 186 studies of sufficient quality that measured indices of sympathetic (n = 113) and/or parasympathetic activity (n = 73). A range of psychological stressors perturbed blood pressure and heart rate. There were comparable aggregate effects for sympathetic activation, as indexed by increased plasma epinephrine and norepinephrine, and shortened pre-ejection period and parasympathetic deactivation, as indexed by heart rate variability measures. Effect sizes varied with stress task, sex, and age. In contrast to alpha-adrenergic blockade, beta-blockade attenuated cardiovascular reactivity. Cardiovascular reactivity to acute psychological stress would appear to reflect both beta-adrenergic activation and vagal withdrawal to a largely equal extent.
Forebrain neurocircuitry associated with human reflex cardiovascular control. [2020]Physiological homeostasis depends upon adequate integration and responsiveness of sensory information with the autonomic nervous system to affect rapid and effective adjustments in end organ control. Dysregulation of the autonomic nervous system leads to cardiovascular disability with consequences as severe as sudden death. The neural pathways involved in reflexive autonomic control are dependent upon brainstem nuclei but these receive modulatory inputs from higher centers in the midbrain and cortex. Neuroimaging technologies have allowed closer study of the cortical circuitry related to autonomic cardiovascular adjustments to many stressors in awake humans and have exposed many forebrain sites that associate strongly with cardiovascular arousal during stress including the medial prefrontal cortex, insula cortex, anterior cingulate, amygdala and hippocampus. Using a comparative approach, this review will consider the cortical autonomic circuitry in rodents and primates with a major emphasis on more recent neuroimaging studies in awake humans. A challenge with neuroimaging studies is their interpretation in view of multiple sensory, perceptual, emotive and/or reflexive components of autonomic responses. This review will focus on those responses related to non-volitional baroreflex control of blood pressure and also on the coordinated responses to non-fatiguing, non-painful volitional exercise with particular emphasis on the medial prefrontal cortex and the insula cortex.
Ventral medial prefrontal cortex and cardiovagal control in conscious humans. [2022]The autonomic nervous system plays a critical role in regulating the cardiovascular responses to mental and physical stress. Recent neuroimaging studies have demonstrated that sympathetic outflow to the heart is modulated by the activity of the anterior cingulate cortex (ACC). However, the cortical modulation of cardiovagal activity is still unclear in humans. The present study used functional MRI to investigate the cortical network involved in cardiovagal control. Seventeen healthy individuals performed graded handgrip exercise while heart rate (HR) and cortical activity were recorded. Muscle sympathetic nerve activity (MSNA), mean arterial pressure (MAP) and HR were measured while participants repeated the same protocol in a parallel experiment session. The handgrip exercise elevated HR and MAP without concurrent elevations in MSNA supporting earlier conclusions that the cardiovascular responses are mainly modulated by vagal withdrawal. The imaging data showed activation in the insular cortex, thalamus, parietal cortices and cerebellum during the exercise period. Consistently across all the participants, the HR response correlated with the deactivation in the ventral medial prefrontal cortex (vMPFC), which has substantial anatomical connection with the subcortical autonomic structures. The deactivation of the vMPFC was independent of the motor control and was observed commonly in both left and right hand exercise. Stronger vMPFC deactivation was observed when participants completed a higher intensity exercise that elicited a larger HR response. Our findings support the hypothesis that the vMPFC is involved in modulating the vagal efferent outflow to the heart and the suppression of its activity elevates cardiovascular arousal in conscious humans.
Stress and central autonomic network. [2021]The central autonomic network (CAN) plays a critical role in the stress response, which is triggered by challenges on the homeostasis (physiological stressors) or unpleasant social or environmental situations. This review focuses on the role of areas of the CAN including the insular and anterior cingulate cortices, extended amygdala, hypothalamus, periaqueductal gray and locus coeruleus in the stress response. These areas are interconnected and affect sympathetic or parasympathetic output via their influence on premotor or preganglionic autonomic neurons in the lower brainstem and spinal cord. The insula integrates multiple inputs to create a sense of the physiological state of the body, whereas the anterior cingulate initiates predictive visceromotor commands. The amygdala and bed nucleus of the stria terminalis provide automatic emotional tagging and trigger automatic survival responses to threat via their outputs to the hypothalamus, periaqueductal gray, and lower brainstem. Several regions of the hypothalamus, including the paraventricular nucleus, dorsomedial nucleus and lateral hypothalamic area participate in different patterns of stress response according to the type of stimulus and projections to premotor and preganglionic autonomic neurons. The periaqueductal gray initiates different patterns of autonomic, pain modulatory, and motor responses, including the "fight or flight" or "playing dead" responses. The locus coeruleus promotes emotional learning in the amygdala associated with states of anxiety. Neurons of the C1 area of the rostral ventrolateral medulla elicit sympathoexcitatory responses to internal stressors such as hypoxia and inflammation. The ventromedial medulla, including the nucleus raphe pallidus, initiates sympathoexcitatory responses to social and other external stressors.
Heart Rate Variability as a Translational Dynamic Biomarker of Altered Autonomic Function in Health and Psychiatric Disease. [2023]The autonomic nervous system (ANS) is responsible for the precise regulation of tissue functions and organs and, thus, is crucial for optimal stress reactivity, adaptive responses and health in basic and challenged states (survival). The fine-tuning of central ANS activity relies on the internal central autonomic regulation system of the central autonomic network (CAN), while the peripheral activity relies mainly on the two main and interdependent peripheral ANS tracts, the sympathetic nervous system (SNS) and the parasympathetic nervous system (PNS). In disease, autonomic imbalance is associated with decreased dynamic adaptability and increased morbidity and mortality. Acute or prolonged autonomic dysregulation, as observed in stress-related disorders, affects CAN core centers, thereby altering downstream peripheral ANS function. One of the best established and most widely used non-invasive methods for the quantitative assessment of ANS activity is the computerized analysis of heart rate variability (HRV). HRV, which is determined by different methods from those used to determine the fluctuation of instantaneous heart rate (HR), has been used in many studies as a powerful index of autonomic (re)activity and an indicator of cardiac risk and ageing. Psychiatric patients regularly show altered autonomic function with increased HR, reduced HRV and blunted diurnal/circadian changes compared to the healthy state. The aim of this article is to provide basic knowledge on ANS function and (re)activity assessment and, thus, to support a much broader use of HRV as a valid, transdiagnostic and fully translational dynamic biomarker of stress system sensitivity and vulnerability to stress-related disorders in neuroscience research and clinical psychiatric practice. In particular, we review the functional levels of central and peripheral ANS control, the main neurobiophysiologic theoretical models (e.g., polyvagal theory, neurovisceral integration model), the precise autonomic influence on cardiac function and the definition and main aspects of HRV and its different measures (i.e., time, frequency and nonlinear domains). We also provide recommendations for the proper use of electrocardiogram recordings for HRV assessment in clinical and research settings and highlight pathophysiological, clinical and research implications for a better functional understanding of the neural and molecular mechanisms underlying healthy and malfunctioning brain-heart interactions in individual stress reactivity and psychiatric disorders.