- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03784846
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
109
Phase
- 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
-
-
New Mexico
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Albuquerque, New Mexico, United States, 87106
- University of New Mexico
-
-
Oregon
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Forest Grove, Oregon, United States, 97116
- Pacific University
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-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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
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
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
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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
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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
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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
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Change in Self-Compassion
Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
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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.
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.
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)
October 1, 2019
Primary Completion (Actual)
May 17, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
December 13, 2018
First Submitted That Met QC Criteria
December 19, 2018
First Posted (Actual)
December 24, 2018
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 9, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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