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

Primary Purpose

Stress, Psychological, Aggression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Resilience Training
Stress Management Education
Sponsored by
Pacific University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Psychological

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of New Mexico
  • Pacific University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Mindfulness-Based Resilience Training

Stress Management Education

No Intervention Control

Arm Description

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.

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 contact control condition (other than baseline, post, and follow-up assessments)

Outcomes

Primary Outcome Measures

Change in Aggression
Buss-Perry Aggression Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater aggression.

Secondary Outcome Measures

Change in C-reactive Protein
Blood spot analysis of high-sensitivity C-reactive protein.
Change in Interleukin-6
Blood spot analysis of interleukin-6.
Change in Interleukin-10
Blood spot analysis of interleukin-10.
Change in Tumor Necrosis Factor-alpha
Blood spot analysis of tumor necrosis factor-alpha.
Change in Psychological Resilience
Brief Resilience Scale. Scores range from 1-5, with higher scores indicating greater resilience.
Change in Alcohol Use
Patient Reported Outcome Measurement System (PROMIS) Alcohol Use. Scores range from 39-77, with higher scores indicating greater alcohol use.
Change in Alcohol Use Negative Consequences
Patient Reported Outcome Measurement System (PROMIS) Alcohol Use Negative Consequences.Scores range from 39-77, with higher scores indicating greater alcohol use negative consequences.
Change in Depression
Patient Reported Outcome Measurement System (PROMIS) Depression. Scores range from 38-80, with higher scores indicating more depression.
Change in Suicidal Thinking
Concise Heath Risk Tracking Scale-Self-Report. Scores range from 7-35, with higher scores indicating greater suicidal ideation.
Change in Trauma Symptoms
PTSD Checklist for DSM-5. Scores ranges from 0-80, with higher scores indicating greater PTSD symptoms.
Change in Burnout
Oldenburg Burnout Inventory. Scores range from 1-4, with higher scores indicating greater burnout.
Change in Sustained Attention
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.
Change in Perceived Stress
Perceived Stress Scale-10. Scores range from 0-40, with higher scores indicating greater perceived stress.
Change in Sleep Disturbance
Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance. Scores range from 32-76, with higher scores indicating greater sleep disturbance.
Change in Self-Compassion
Self-Compassion Scale-Short Form. Scores range from 1-5, with higher scores indicating greater self-compassion.
Change in Mindfulness
Five Facet Mindfulness Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater mindfulness.
Change in Interoceptive Awareness
Multidimensional Assessment of Interoceptive Awareness-II. Scores range from 1-6, with higher scores indicating greater interoceptive awareness.
Treatment Acceptability
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.
Treatment Compliance
Objective assessment of duration of homework practice. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.
Treatment Expectancy and Credibility
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.
Global Impression of Change
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.

Full Information

First Posted
December 13, 2018
Last Updated
June 9, 2023
Sponsor
Pacific University
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03784846
Brief Title
Mindfulness-Based Resilience Training for Aggression, Health, and Stress Among Law Enforcement Officers
Official Title
Mindfulness-Based Resilience Training for Aggression, Health, and Stress Among Law Enforcement Officers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
May 17, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pacific University
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Aggression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Individually-Randomized Group Treatment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Resilience Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Stress Management Education
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Intervention Control
Arm Type
No Intervention
Arm Description
No contact control condition (other than baseline, post, and follow-up assessments)
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Resilience Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stress Management Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Aggression
Description
Buss-Perry Aggression Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater aggression.
Time Frame
baseline, post-intervention (week 8), 3-month followup, 6-month followup
Secondary Outcome Measure Information:
Title
Change in C-reactive Protein
Description
Blood spot analysis of high-sensitivity C-reactive protein.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup
Title
Change in Interleukin-6
Description
Blood spot analysis of interleukin-6.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup
Title
Change in Interleukin-10
Description
Blood spot analysis of interleukin-10.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup
Title
Change in Tumor Necrosis Factor-alpha
Description
Blood spot analysis of tumor necrosis factor-alpha.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup
Title
Change in Psychological Resilience
Description
Brief Resilience Scale. Scores range from 1-5, with higher scores indicating greater resilience.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Title
Change in Alcohol Use
Description
Patient Reported Outcome Measurement System (PROMIS) Alcohol Use. Scores range from 39-77, with higher scores indicating greater alcohol use.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Title
Change in Alcohol Use Negative Consequences
Description
Patient Reported Outcome Measurement System (PROMIS) Alcohol Use Negative Consequences.Scores range from 39-77, with higher scores indicating greater alcohol use negative consequences.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Title
Change in Depression
Description
Patient Reported Outcome Measurement System (PROMIS) Depression. Scores range from 38-80, with higher scores indicating more depression.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Title
Change in Suicidal Thinking
Description
Concise Heath Risk Tracking Scale-Self-Report. Scores range from 7-35, with higher scores indicating greater suicidal ideation.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Title
Change in Trauma Symptoms
Description
PTSD Checklist for DSM-5. Scores ranges from 0-80, with higher scores indicating greater PTSD symptoms.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Title
Change in Burnout
Description
Oldenburg Burnout Inventory. Scores range from 1-4, with higher scores indicating greater burnout.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Title
Change in Sustained Attention
Description
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.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Title
Change in Perceived Stress
Description
Perceived Stress Scale-10. Scores range from 0-40, with higher scores indicating greater perceived stress.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Title
Change in Sleep Disturbance
Description
Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance. Scores range from 32-76, with higher scores indicating greater sleep disturbance.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Title
Change in Self-Compassion
Description
Self-Compassion Scale-Short Form. Scores range from 1-5, with higher scores indicating greater self-compassion.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Title
Change in Mindfulness
Description
Five Facet Mindfulness Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater mindfulness.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Title
Change in Interoceptive Awareness
Description
Multidimensional Assessment of Interoceptive Awareness-II. Scores range from 1-6, with higher scores indicating greater interoceptive awareness.
Time Frame
baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Title
Treatment Acceptability
Description
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.
Time Frame
post-intervention (8 weeks)
Title
Treatment Compliance
Description
Objective assessment of duration of homework practice. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.
Time Frame
post-intervention (8 weeks)
Title
Treatment Expectancy and Credibility
Description
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.
Time Frame
baseline
Title
Global Impression of Change
Description
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.
Time Frame
post-intervention (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Pacific University
City
Forest Grove
State/Province
Oregon
ZIP/Postal Code
97116
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32111233
Citation
Christopher M, Bowen S, Witkiewitz K. Mindfulness-based resilience training for aggression, stress and health in law enforcement officers: study protocol for a multisite, randomized, single-blind clinical feasibility trial. Trials. 2020 Feb 28;21(1):236. doi: 10.1186/s13063-020-4165-y.
Results Reference
result

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

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