Autonomic Modulation Training for Stress

(AMT Trial)

Overseen By Judith P Andersen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Non-canadian officers, Administrators, Civilians, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

250 Participants Needed

What You Need to Know Before You Apply

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.

Is Autonomic Modulation Training (AMT) safe for humans?

The research on similar treatments like behavioral neurocardiac training and transcutaneous auricular vagus nerve stimulation suggests they are generally safe, as they focus on modulating heart rate and stress responses without reported adverse effects. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Autonomic Modulation Training for stress?

Research shows that similar treatments like transcutaneous auricular Vagus Nerve Stimulation and Median Nerve Stimulation can reduce stress by affecting physiological markers, suggesting that Autonomic Modulation Training might also help manage stress effectively. ^{6 11 12 13 14}

Who Is on the Research Team?

Judith P Andersen, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Autonomic Modulation Training

Trial Overview The 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.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 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: Control Active Control 1 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

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

The study evaluated the effectiveness of transcutaneous Peripheral Nerve Stimulation (PNS) methods—auricular (taVNS), cervical (tcVNS), and median nerve stimulation (tMNS)—in reducing physiological stress responses in 19 young healthy volunteers during acute stressors, showing that taVNS and tMNS significantly reduced sympathetic arousal.

Both taVNS and tMNS led to measurable improvements in heart function and reduced stress indicators, suggesting their potential for use in personalized stress management therapies to enhance quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular Vagus Nerve Stimulation and Median Nerve Stimulation reduce acute stress in young healthy adults: a single-blind sham-controlled crossover study. Sanchez-Perez, JA., Gazi, AH., Rahman, FN., et al.[2023]

Autogenic training (AT) significantly reduced stress responses in nursing students, as indicated by subjective assessments, after an 8-week program involving 40 participants.

However, AT did not show a significant impact on objective measures of heart rate variability, suggesting that while it may help with perceived stress, it might not affect physiological stress markers in the same way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of autogenic training on stress response and heart rate variability in nursing students. Lim, SJ., Kim, C.[2016]

In a study of 77 patients undergoing in-patient psychotherapy for psychosomatic disorders, significant symptom improvements were observed, but there was no change in autonomic regulation or hemodynamic responses during rest or mental stress tests.

The findings suggest that while psychotherapy may alleviate symptoms, its short-term effects do not translate to improved autonomic function, indicating that further research is needed to explore the long-term benefits of increased physical activity and relaxation following treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stability of mental stress-induced hemodynamic and autonomic reaction despite successful treatment for psychosomatic disorder]. Lomb, J., Kleiber, C., Herrmann-Lingen, C.[2016]

In a study of 29 trauma survivors, those with PTSD showed a lack of increase in respiratory sinus arrhythmia (RSA) during stress, indicating a different heart rate response compared to those without PTSD.

The findings suggest that PTSD may involve sympathetic mechanisms for heart rate control during stress, rather than the vagal control seen in trauma survivors without PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vagal modulation of responses to mental challenge in posttraumatic stress disorder. Sahar, T., Shalev, AY., Porges, SW.[2019]

Imagery suggestions used in autogenic training can specifically influence autonomic responses, as shown by the experiment with nine subjects over six days.

The 'cool' imagery led to increased heart rate and respiration, while the 'warm' imagery did not produce significant changes, indicating that different types of imagery can have distinct physiological effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visceral responses to opposite types of autogenic-training imagery. Blizard, DA., Cowings, P., Miller, NE.[2019]

In a study of 22 male fire service workers, autogenic training (AT) significantly improved cardiac autonomic nervous activity by decreasing sympathetic and increasing parasympathetic activity, particularly in those with PTSD-related stress.

AT also led to a notable reduction in PTSD symptoms, as indicated by a significant decrease in scores on the Impact of Event Scale-Revised (IES-R-J), demonstrating its efficacy in addressing both psychological and physiological stress responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of autogenic training on cardiac autonomic nervous activity in high-risk fire service workers for posttraumatic stress disorder. Mitani, S., Fujita, M., Sakamoto, S., et al.[2015]

Behavioral neurocardiac training (BNT) significantly reduced daytime and 24-hour systolic blood pressure in patients with uncomplicated hypertension, demonstrating its efficacy as a treatment option alongside pharmacological therapy.

BNT also improved heart rate variability during cognitive stress tasks, indicating enhanced vagal modulation, while the control group showed no significant changes, suggesting that BNT may offer additional benefits beyond standard relaxation techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral neurocardiac training in hypertension: a randomized, controlled trial. Nolan, RP., Floras, JS., Harvey, PJ., et al.[2022]

Work-related stress in 91 white-collar workers was linked to increased stress symptoms and altered heart rate variability, indicating dysregulation of the autonomic nervous system compared to 79 healthy controls.

A simple onsite stress management program, involving cognitive restructuring and relaxation training, significantly improved heart rate variability and slightly reduced systolic blood pressure, suggesting potential benefits for preventing hypertension in stressed workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress management at the worksite: reversal of symptoms profile and cardiovascular dysregulation. Lucini, D., Riva, S., Pizzinelli, P., et al.[2018]

In a study involving 24 healthy adults, transcutaneous auricular vagus nerve stimulation (taVNS) was found to significantly reduce the initial heart rate increase during a cold pressor test, suggesting a potential calming effect on the body's stress response.

While taVNS showed a difference in heart rate response compared to sham stimulation, there were no significant differences in subjective feelings of anxiety, stress, or pain, indicating that while taVNS may affect physiological responses, it does not necessarily alter perceived stress levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation Attenuates Early Increases in Heart Rate Associated With the Cold Pressor Test. Austelle, CW., Sege, CT., Kahn, AT., et al.[2023]

A comprehensive analysis of 186 studies revealed that both sympathetic activation (increased levels of epinephrine and norepinephrine) and parasympathetic deactivation (measured through heart rate variability) significantly contribute to cardiovascular stress responses.

The study found that beta-blockade effectively reduced cardiovascular reactivity to stress, indicating that both beta-adrenergic activation and vagal withdrawal play important roles in how our bodies respond to psychological stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A tale of two mechanisms: a meta-analytic approach toward understanding the autonomic basis of cardiovascular reactivity to acute psychological stress. Brindle, RC., Ginty, AT., Phillips, AC., et al.[2014]

The autonomic nervous system plays a crucial role in maintaining cardiovascular health, and its dysregulation can lead to severe consequences, including sudden death.

Recent neuroimaging studies have identified key brain regions, such as the medial prefrontal cortex and insula cortex, that are involved in autonomic control of blood pressure and cardiovascular responses to stress and exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Forebrain neurocircuitry associated with human reflex cardiovascular control. Shoemaker, JK., Goswami, R.[2020]

The study involved 17 healthy individuals performing handgrip exercises while their heart rate and brain activity were monitored, revealing that cardiovascular responses are primarily regulated by vagal withdrawal rather than sympathetic nerve activity.

Functional MRI results indicated that deactivation of the ventral medial prefrontal cortex (vMPFC) correlates with increased heart rate during exercise, suggesting that the vMPFC plays a key role in modulating heart activity and cardiovascular arousal in response to physical stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventral medial prefrontal cortex and cardiovagal control in conscious humans. Wong, SW., Massé, N., Kimmerly, DS., et al.[2022]

The central autonomic network (CAN) is crucial for managing the body's stress response, integrating signals from various brain regions to influence autonomic functions like heart rate and blood pressure.

Key areas such as the insula and anterior cingulate cortex help interpret physiological states and initiate responses, while the amygdala and hypothalamus trigger automatic survival reactions to stressors, highlighting the complex interplay between emotional and physiological responses to stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress and central autonomic network. Lamotte, G., Shouman, K., Benarroch, EE.[2021]

The autonomic nervous system (ANS) plays a crucial role in regulating bodily functions and stress responses, and its imbalance can lead to increased health risks, particularly in stress-related disorders.

Heart rate variability (HRV) is a valuable non-invasive tool for assessing ANS activity, with altered HRV patterns observed in psychiatric patients, indicating its potential as a biomarker for stress sensitivity and vulnerability in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart Rate Variability as a Translational Dynamic Biomarker of Altered Autonomic Function in Health and Psychiatric Disease. Agorastos, A., Mansueto, AC., Hager, T., et al.[2023]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular Vagus Nerve Stimulation and Median Nerve Stimulation reduce acute stress in young healthy adults: a single-blind sham-controlled crossover study. [2023]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Effects of autogenic training on stress response and heart rate variability in nursing students. [2016]

3. Germany pubmed.ncbi.nlm.nih.gov

[Stability of mental stress-induced hemodynamic and autonomic reaction despite successful treatment for psychosomatic disorder]. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Vagal modulation of responses to mental challenge in posttraumatic stress disorder. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Visceral responses to opposite types of autogenic-training imagery. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Effect of autogenic training on cardiac autonomic nervous activity in high-risk fire service workers for posttraumatic stress disorder. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Behavioral neurocardiac training in hypertension: a randomized, controlled trial. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Stress management at the worksite: reversal of symptoms profile and cardiovascular dysregulation. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation Attenuates Early Increases in Heart Rate Associated With the Cold Pressor Test. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A tale of two mechanisms: a meta-analytic approach toward understanding the autonomic basis of cardiovascular reactivity to acute psychological stress. [2014]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Forebrain neurocircuitry associated with human reflex cardiovascular control. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Ventral medial prefrontal cortex and cardiovagal control in conscious humans. [2022]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Stress and central autonomic network. [2021]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Heart Rate Variability as a Translational Dynamic Biomarker of Altered Autonomic Function in Health and Psychiatric Disease. [2023]