Recruiting

Autonomic Modulation Training

Sponsor:

University of Toronto

Code:

NCT05521360

Conditions

Stress, Physiological

Stress, Psychological

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Autonomic Modulation Training

Study Details

Brief summary:

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.

Conditions

Stress, Physiological

Stress, Psychological

Study ID

NCT05521360

Start date

Jan 30, 2023

Status verified date

Nov, 2023

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Current employment as an active duty (i.e., not on an extended medical or disability leave) frontline law enforcement officer in Canada.
  • Must be fluent in English.

Exclusion Criteria:

  • Non-Canadian law enforcement officers. Police administrators and civilian employees (i.e., non-sworn members) are not eligible.
  • Officers that do not have weekly access to a personal computer to complete the online AMT intervention

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Experimental

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)

no intervention: Control

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.

Interventions

Autonomic Modulation Training

AMT is a six week online behavioral intervention comprised of two components. The first component is an adapted (to online format) version of an established and publicly available HRVBF protocol (Lehrer et al, 2013, Biofeedback).The second is the integration of meta-cognitive coping skills and autonomic modulation breathing techniques into the HRVBF protocol (Arpaia \& Andersen, 2019 Frontiers in Psychiatry; Andersen, Arpaia \& Gustafsberg, 2021 Int J Emerg Ment Health and Human Resilience).

Primary outcome measure

  • Post-traumatic stress disorder (PTSD) symptoms [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Depression symptoms [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Global psychological symptoms [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Anxiety symptoms [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Alcohol use [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Perceived stress [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Self-reported stress [ Time Frame: From baseline to follow-up (immediate post intervention assessment) and session-to-session changes ]
  • COVID stress experience [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Burnout symptoms [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Occupational police stress [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Coping [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • General resilience [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Social resilience [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Thought suppression [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Repetitive thinking [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Worry [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Rumination [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Good health practices [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Overall functional wellness [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Difficulties in performing life activities due to health conditions [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Difficulties in performing work activities due to health conditions [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Workplace discrimination [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Gender-based workplace harassment [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Resting heart rate variability (HRV) [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Physiological recovery from acute stress [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Respiratory Sinus Arrhythmia (RSA) [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]
  • Sex and gender differences in PTSI, occupational stress, and physiology [ Time Frame: From baseline to follow-up (immediate post intervention assessment) ]

Central Contacts and Locations

Locations

University of Toronto Mississauga

Recruiting

Mississauga, Ontario, Canada, L5L 1C6

Contacts

Principal Investigator:

Judith P Andersen, PhD

More Information

Sponsor

University of Toronto

Last update posted

Nov 30, 2023

Last verified

Nov, 2023

Keywords

  • Post Traumatic Stress Symptoms
  • Depressive Symptoms
  • Anxiety Symptoms
  • Operational Stress
  • Organizational Stress
  • Police
  • HRV Biofeedback
  • Psychophysiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Toronto on 2023-11-30.