Mindfulness-Based Resilience Training for Aggression, Health, and Stress Among Law Enforcement Officers

June 9, 2023 updated by: Michael Christopher, PhD, Pacific University
Law enforcement officers (LEOs) are exposed to significant stressors, elevating their risk for aggression and excessive use of force, as well as mental health consequences, including post-traumatic stress disorder, burnout, alcohol misuse, depression, and suicide. The proposed study will identify, optimize and refine best clinical and research practices across two sites to ensure success in a future multisite efficacy trial assessing preventative effects of Mindfulness-Based Resilience Training on physiological, behavioral, and psychological outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Law enforcement officers (LEOs) are exposed to significant stressors, elevating their risk for aggression and excessive use of force. Such dysfunctional stress reactivity can lead to devastating consequences for their community, including unjustified shootings, severe beatings, and fatal chokings. It can also lead to serious consequences for the LEOs, including elevated incidence of post-traumatic stress disorder, burnout, alcohol misuse, depression, and suicide. A recent meta-analysis of LEO stress reduction programs found little evidence to demonstrate that such approaches are effective, highlighting the urgent need for preventive interventions targeting the stress inherent to policing. Mindfulness training is a promising approach with high-stress populations that has been shown effective in reducing stress and increasing resilience. In a recent pilot feasibility study (R21AT008854), the study team established initial feasibility, acceptability, and adherence to procedures in a single-site RCT assessing Mindfulness-Based Resilience Training (MBRT), a preventive intervention designed to improve LEO mental health and resilience, and reduce aggression and excessive use of force. The R21 data suggest physiological mechanisms and potential clinical benefit in a sample of LEOs. Relative to waitlist control, MBRT participants showed improvements in stress reactivity, aggression, burnout, occupational stress, sleep disturbance, and psychological flexibility. Implemented at two sites, the proposed study is designed to establish optimal protocols and procedures for a future full-scale, multi-site trial assessing effects of MBRT versus an attention control (Stress Management Education) and a no-intervention control, on physiological, behavioral, and psychological outcomes. To prepare for this future clinical trial, this study will: a) enhance efficiency of recruitment, engagement and retention; b) optimize lab, assessment, and data management procedures; c) optimize intervention training and ensure fidelity to intervention protocols; and d) assess participant experience and optimize outcome measures across sites. The long-term objective of this line of research is to develop an intervention that will reduce violence and increase resilience among LEOs, as well as yield significant benefits for communities and residents they serve.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
109

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • University of New Mexico
    • Oregon
      • Forest Grove, Oregon, United States, 97116
        • Pacific University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • be 21-65 years old (age limitations for both police departments),
  • demonstrate English fluency,
  • be a sworn, full-time, active status law enforcement officer,
  • agree to random assignment to condition, and
  • be willing to complete assessments at multiple time points and attend intervention groups

Exclusion Criteria:

  • previous participation in MBSR, MBRT or a similar mindfulness course,
  • score in the severe range on brief screening measures of depression, suicidal ideation, alcohol use, or PTSD, or
  • unable or unwilling to give written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness-Based Resilience Training
MBRT is an 8-week program combining training in standardized mindfulness practices targeting factors that facilitate resilience, cognitive behavioral therapy (CBT), and psychoeducation. It contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions.
Behavioral: Mindfulness-Based Resilience Training
MBRT is an 8-week program combining training in standardized mindfulness practices targeting factors that facilitate resilience, CBT, and psychoeducation. It contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions.
Active Comparator: Stress Management Education
SME was designed as an active control condition for other mindfulness-based intervention trials. SME uses a group-based didactic approach with modules on physiological and dietary effects of stress, time management, sleep physiology and insomnia, nutrition, exercise, stress hardiness, and factors mitigating impacts of stress.
Behavioral: Stress Management Education
SME was designed as an active control condition for other Mindfulness-Based Intervention trials. SME uses a group-based didactic approach with modules on physiological and dietary effects of stress, time management, sleep physiology and insomnia, nutrition, exercise, stress hardiness, and factors mitigating impacts of stress.
No Intervention: No Intervention Control
No contact control condition (other than baseline, post, and follow-up assessments)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Aggression
Time Frame: baseline, post-intervention (week 8), 3-month followup, 6-month followup
Buss-Perry Aggression Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater aggression.
baseline, post-intervention (week 8), 3-month followup, 6-month followup

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Psychological Resilience
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Brief Resilience Scale. Scores range from 1-5, with higher scores indicating greater resilience.
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Alcohol Use
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Patient Reported Outcome Measurement System (PROMIS) Alcohol Use. Scores range from 39-77, with higher scores indicating greater alcohol use.
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Alcohol Use Negative Consequences
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Patient Reported Outcome Measurement System (PROMIS) Alcohol Use Negative Consequences.Scores range from 39-77, with higher scores indicating greater alcohol use negative consequences.
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Depression
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Patient Reported Outcome Measurement System (PROMIS) Depression. Scores range from 38-80, with higher scores indicating more depression.
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Suicidal Thinking
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Concise Heath Risk Tracking Scale-Self-Report. Scores range from 7-35, with higher scores indicating greater suicidal ideation.
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Trauma Symptoms
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
PTSD Checklist for DSM-5. Scores ranges from 0-80, with higher scores indicating greater PTSD symptoms.
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Burnout
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Oldenburg Burnout Inventory. Scores range from 1-4, with higher scores indicating greater burnout.
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Perceived Stress
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Perceived Stress Scale-10. Scores range from 0-40, with higher scores indicating greater perceived stress.
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Sleep Disturbance
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance. Scores range from 32-76, with higher scores indicating greater sleep disturbance.
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in C-reactive Protein
Time Frame: baseline, post-intervention (8 weeks), 3 month followup
Blood spot analysis of high-sensitivity C-reactive protein.
baseline, post-intervention (8 weeks), 3 month followup
Change in Interleukin-6
Time Frame: baseline, post-intervention (8 weeks), 3 month followup
Blood spot analysis of interleukin-6.
baseline, post-intervention (8 weeks), 3 month followup
Change in Interleukin-10
Time Frame: baseline, post-intervention (8 weeks), 3 month followup
Blood spot analysis of interleukin-10.
baseline, post-intervention (8 weeks), 3 month followup
Change in Tumor Necrosis Factor-alpha
Time Frame: baseline, post-intervention (8 weeks), 3 month followup
Blood spot analysis of tumor necrosis factor-alpha.
baseline, post-intervention (8 weeks), 3 month followup
Change in Sustained Attention
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Sustained Attention to Response Task. A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amongst a background of frequent non-targets. Increased errors indicates less sustained attention.
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Self-Compassion
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Self-Compassion Scale-Short Form. Scores range from 1-5, with higher scores indicating greater self-compassion.
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Mindfulness
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Five Facet Mindfulness Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater mindfulness.
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Interoceptive Awareness
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Multidimensional Assessment of Interoceptive Awareness-II. Scores range from 1-6, with higher scores indicating greater interoceptive awareness.
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Treatment Acceptability
Time Frame: post-intervention (8 weeks)
Postcourse satisfaction survey. Scores range from 4-16, with higher scores indicating greater treatment acceptability. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.
post-intervention (8 weeks)
Treatment Compliance
Time Frame: post-intervention (8 weeks)
Objective assessment of duration of homework practice. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.
post-intervention (8 weeks)
Treatment Expectancy and Credibility
Time Frame: baseline
Expectancy/Credibility Questionnaire. Scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies. Scores range from 7-21, with higher scores indicating greater expectancy and credibility.
baseline
Global Impression of Change
Time Frame: post-intervention (8 weeks)
Clinical Global Impressions Scale. Measure of perceived change in functioning as a result of the intervention. Scores range from 3-21, with higher scores indicating a greater impression of change. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.
post-intervention (8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pacific University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1295787-14
  • U01AT009841 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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