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Impact of Mindfulness Training on Stress-related Health Outcomes in Law Enforcement

Primary Purpose

Stress, Psychological, Sleep, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mMBRT
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress, Psychological

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • At least 18 years of age
  • Capable of giving informed consent
  • Fluent in English
  • Currently employed sworn law enforcement officer working in the Dane County Sheriff's Office, Madison Police Department, or University of Wisconsin-Madison Police Department.

Exclusion Criteria:

  • Extensive prior experience in meditation practice, or previous completion of Mindfulness-Based Stress Reduction, Mindfulness-Based Resilience Training, or a substantively similar meditation training program
  • A work schedule that precludes one from committing to regular participation in the 8-week training program
  • Command staff working in a supervisory role

Sites / Locations

  • Center for Healthy Minds, University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

mMBRT

Waitlist control group

Arm Description

Individuals in the mMBRT group will receive an 8-week mindfulness-based intervention in groups of approximately 15 individuals in 8 weekly 2-hour classes (one of these classes, toward the end of the course, is approximately 4 hours and integrates many of the practices and teachings covered throughout the training program).

Individuals in the waitlist control group will complete the same assessments as those in the active treatment group, but will not be offered any intervention until the conclusion of the trial. At this time, control group participants will be offered the intervention.

Outcomes

Primary Outcome Measures

Change in perceived occupational stress
Change in combined scores of perceived operational and organizational stressors from the Police Stress Questionnaire (McCreary & Thompson, 2004) from baseline to 3 months. Each of these 2 scales has 20 items with 1-7 ratings, where higher scores indicate greater stress (1=no stress at all, 7=A lot of stress). Organizational and operational stress scales will be summed to create a single value with a range of 40-280.
Change in diurnal cortisol slope
Saliva samples collected on each of 3 days will be used to calculate diurnal cortisol slope, defined as the change between the peak cortisol response in the 45 minutes after awakening and cortisol levels just prior to bedtime, with a hypothesized steeper slope in the intervention vs. waitlist group at post-intervention (3 months) vs. baseline.

Secondary Outcome Measures

Change in cortisol awakening response
The cortisol awakening response (CAR) will be measured using saliva samples collected 0, 30, and 45 minutes after awakening on each of 3 days, with hypothesized increased CAR in the intervention vs. waitlist group at post-intervention (3 months) vs. baseline.
Change in peripheral inflammatory markers
Composite of hsCRP and 4-plex of pro-inflammatory cytokines (IL-6, IL-8, IL-10, TNF-alpha) is hypothesized to be lower in intervention vs. waitlist group at post-intervention (3 months) vs. baseline.
Change in hyperarousal symptoms
Change in hyperarousal symptoms from the PTSD Checklist for DSM-5 at post-intervention (3 months) vs. baseline
Change in subjective sleep quality
Global scores on the Pittsburgh Sleep Quality Index (Buysse et al., 1988) will be compared at post-intervention (3 months) vs. baseline
Change in perceived stress
Changes in total scores from the Perceived Stress Scale (10-item version; Cohen et al., 1988) from baseline to 3 months.

Full Information

First Posted
March 22, 2018
Last Updated
January 16, 2020
Sponsor
University of Wisconsin, Madison
Collaborators
U.S. Department of Justice
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1. Study Identification

Unique Protocol Identification Number
NCT03488875
Brief Title
Impact of Mindfulness Training on Stress-related Health Outcomes in Law Enforcement
Official Title
The Impact of Mindfulness-Based Resilience Training on Stress-Related Biological, Behavioral, and Health-Related Outcomes in Law Enforcement Officers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
U.S. Department of Justice

4. Oversight

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

5. Study Description

Brief Summary
In a sample of 120 officers from Dane County law enforcement agencies, the investigators are conducting a randomized controlled trial of an 8-week mindfulness-based training program for police officers, Madison Mindfulness-Based Resilience Training (mMBRT), and investigating the impact of this training on subjective responses to stress, stress-related psychological and physical health outcomes, and biological and behavioral correlates of perceived stress. While the benefits of mindfulness-based interventions have been documented in a variety of populations, this will be the largest and most comprehensive study of its kind of law enforcement personnel. In addition to self-report measures, this study assesses an array of objective biological and behavioral outcomes both in the laboratory and in the field that may speak to mechanisms of change involved in symptom reduction.
Detailed Description
120 police officers will be recruited from Dane County law enforcement agencies to take part in an 8-week, group-based, mindfulness-based training program called Madison Mindfulness-Based Resilience Training (mMBRT). Officers will be randomized to an active group, which will receive mMBRT immediately after baseline assessments, and a waitlist control group, which will receive mMBRT after a post-intervention assessment and a subsequent follow-up assessment. mMBRT is similar to and inspired by MBRT, and both of these programs are law enforcement-specific interventions based on Mindfulness-Based Stress Reduction (MBSR), a commonly used mindfulness program in many healthcare settings. mMBRT is structurally similar to MBSR, with 8 weekly 2-hour classes involving guided meditation practices, gentle movement, and group-based discussion (one of these classes, toward the end of the course, is approximately 4 hours and integrates many of the practices and teachings covered throughout the training program). Participants will be provided with weekly homework assignments and audio recordings that provide guided instruction in various meditation and yoga practices. At three separate timepoints, officers will take part in a laboratory assessment that involves the following procedures: administration of computerized behavioral tasks completion of self-report questionnaires that assess trauma history and occupational stressors, perceived stress, sleep, physical and mental health collection of a small amount of blood via finger prick and/or venipuncture (to assess peripheral inflammatory markers) collection of a small amount of hair from the scalp (to assess hair cortisol concentration) measurement of height and weight for the assessment of body mass index, and for use with activity trackers data In conjunction with these laboratory assessments, data will be collected from officers in the field over the course of approximately 1 week (coinciding with a regularly scheduled work week), including the following procedures: officers will wear an activity monitor (e.g., Fitbit) to allow for objective monitoring of sleep quality and resting heart rate throughout the study officers will collect saliva samples 4 times per day over 3 days for the assessment of salivary cortisol officers will complete daily logs of work hours, types of events encountered during work, perceived stress related to these events, and self-reported mood and affect ratings These field data will be related to dispatch records, which will provide objective information regarding the types of incidents responded to, and the time and location of these incidents. The laboratory and field assessments will be collected at baseline (prior to randomization); after the active mMBRT group completes the intervention; and at a follow-up visit (approximately 4 months after the end of the intervention), after which the wait-list group will be offered the intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Sleep, Inflammation, Mental Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to an active treatment group and a waitlist control group.
Masking
None (Open Label)
Masking Description
Participants cannot be made blind to study assignment due to the nature of the intervention. Baseline (T1) measures will be collected prior to treatment assignment. Every effort will be taken to minimize knowledge of group assignment by the study team, in particular the PI and other individuals involved in data analysis; however, the small size of the study team and overlapping roles of team members may preclude masking of group assignment for all members of the study team.
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mMBRT
Arm Type
Experimental
Arm Description
Individuals in the mMBRT group will receive an 8-week mindfulness-based intervention in groups of approximately 15 individuals in 8 weekly 2-hour classes (one of these classes, toward the end of the course, is approximately 4 hours and integrates many of the practices and teachings covered throughout the training program).
Arm Title
Waitlist control group
Arm Type
No Intervention
Arm Description
Individuals in the waitlist control group will complete the same assessments as those in the active treatment group, but will not be offered any intervention until the conclusion of the trial. At this time, control group participants will be offered the intervention.
Intervention Type
Behavioral
Intervention Name(s)
mMBRT
Other Intervention Name(s)
Madison Mindfulness-Based Resilience Training, MBRT
Intervention Description
Madison Mindfulness-Based Resilience Training (mMBRT) is an 8-week mindfulness-based intervention developed specifically for police officers, which is similar to and inspired by a program developed by researchers at Pacific (OR) University (Christopher, Goerling et al., 2016). mMBRT includes 8 weekly 2-hour classes involving guided meditation practice, gentle movement, and group-based discussion (the 7th class is a longer, 4-hour class). The total class time is about 18 hours over 8 weeks, and participants are asked to engage in home practice for up to 30 minutes/day, 6 days/week throughout the intervention.
Primary Outcome Measure Information:
Title
Change in perceived occupational stress
Description
Change in combined scores of perceived operational and organizational stressors from the Police Stress Questionnaire (McCreary & Thompson, 2004) from baseline to 3 months. Each of these 2 scales has 20 items with 1-7 ratings, where higher scores indicate greater stress (1=no stress at all, 7=A lot of stress). Organizational and operational stress scales will be summed to create a single value with a range of 40-280.
Time Frame
Baseline, post-intervention (3 months)
Title
Change in diurnal cortisol slope
Description
Saliva samples collected on each of 3 days will be used to calculate diurnal cortisol slope, defined as the change between the peak cortisol response in the 45 minutes after awakening and cortisol levels just prior to bedtime, with a hypothesized steeper slope in the intervention vs. waitlist group at post-intervention (3 months) vs. baseline.
Time Frame
Baseline, post-intervention (3 months)
Secondary Outcome Measure Information:
Title
Change in cortisol awakening response
Description
The cortisol awakening response (CAR) will be measured using saliva samples collected 0, 30, and 45 minutes after awakening on each of 3 days, with hypothesized increased CAR in the intervention vs. waitlist group at post-intervention (3 months) vs. baseline.
Time Frame
Baseline, post-intervention (3 months)
Title
Change in peripheral inflammatory markers
Description
Composite of hsCRP and 4-plex of pro-inflammatory cytokines (IL-6, IL-8, IL-10, TNF-alpha) is hypothesized to be lower in intervention vs. waitlist group at post-intervention (3 months) vs. baseline.
Time Frame
Baseline, post-intervention (3 months)
Title
Change in hyperarousal symptoms
Description
Change in hyperarousal symptoms from the PTSD Checklist for DSM-5 at post-intervention (3 months) vs. baseline
Time Frame
Baseline, post-intervention (3 months), follow-up (6 months)
Title
Change in subjective sleep quality
Description
Global scores on the Pittsburgh Sleep Quality Index (Buysse et al., 1988) will be compared at post-intervention (3 months) vs. baseline
Time Frame
Baseline, post-intervention (3 months)
Title
Change in perceived stress
Description
Changes in total scores from the Perceived Stress Scale (10-item version; Cohen et al., 1988) from baseline to 3 months.
Time Frame
Baseline, post-intervention (3 months)
Other Pre-specified Outcome Measures:
Title
Change in hair cortisol concentration
Description
Hair cortisol concentration will be assessed from a 3-cm sample of hair collected from participants' scalps, corresponding to approximately 3 months of hair growth, at 6 months vs. baseline.
Time Frame
Baseline, follow-up (6 months)
Title
Change in restful minutes of sleep
Description
Change in minutes of behaviorally assessed restful sleep time during 1 week of sleep measured in the field using Fitbit Charge 2 activity trackers at post-intervention (3 months) vs. baseline.
Time Frame
5-7 nights of sleep will be monitored at baseline and post-intervention (3 months)
Title
Change in behavioral pattern separation ability
Description
Changes in lure discrimination index (LDI) scores from the Mnemonic Similarity Task (Stark et al., 2015) will be assessed between baseline and post-intervention (3 months). LDI scores have a theoretical range of -1 to +1, where a score of +1 indicates perfect ability to discriminate novel items from those previously seen and 0 indicates chance discrimination of novel from previously seen items. Negative scores, while theoretically possible, are rare as they indicate greater labeling of novel items as "old" compared to previously seen items as "old".'
Time Frame
Baseline, post-intervention (3 months)
Title
Change in mood and anxiety symptoms
Description
Change in depression and anxiety subscale scores from the 43-item version of the Patient-Reported Outcomes Measurement Information System (PROMIS-43) at post-intervention (3 months) vs. baseline. There are 6 depression and 6 anxiety items, each of which is scored on a scale of 1 ("never") to 5 ("always"), yielding a range of 6-30 for each subscale with higher scores indicating greater impairment.
Time Frame
Baseline, post-intervention (3 months)
Title
Change in total PTSD symptoms
Description
Change in total PTSD symptoms from the PTSD Checklist for DSM-5 at post-intervention (3 months) vs. baseline
Time Frame
Baseline, post-intervention (3 months)
Title
Change in resting heart rate
Description
Changes in average resting heart rate calculated over 3-7 days of field data collection using a Fitbit Charge 2 activity tracker at post-intervention (3 months) vs. baseline.
Time Frame
Baseline, post-intervention (3 months)
Title
Change in pain interference
Description
Change in pain interference subscale scores from the 43-item version of the Patient-Reported Outcomes Measurement Information System (PROMIS-43) at post-intervention (3 months) vs. baseline.
Time Frame
Baseline, post-intervention (3 months)
Title
Change in burnout
Description
Change in the two core dimensions of burnout, exhaustion and disengagement, on the Oldenburg Burnout Inventory (Halbesleben & Demerouti, 2005) at post-intervention (3 months) vs. baseline.
Time Frame
Baseline, post-intervention (3 months)
Title
Change in work productivity
Description
Change in work productivity, measured as the estimated percentage of work time affected by chronic mental and physical health issues on the Work Limitations Questionnaire (short form; Lerner et al., 2001) at post-intervention (3 months) vs. baseline.
Time Frame
Baseline, post-intervention (3 months)
Title
Change in good health practices
Description
Change in physical health and well-being behaviors as measured by the Good Health Practices Scale (Hampson et al., 2017) at post-intervention (3 months) vs. baseline.
Time Frame
Baseline, post-intervention (3 months)
Title
Change in self-reported mindfulness
Description
Changes in total scores and individual dimensions of the Five-Facet Mindfulness Scale (short form; Bohlmeijer et al., 2011) at post-intervention (3 months) vs. baseline.
Time Frame
Baseline, post-intervention (3 months)
Title
Change in work-family spillover
Description
Change in work-to-family and family-to-work spillover from the Work-Family Spillover Scale (Grzywacz & Marks, 2000) at post-intervention (3 months) vs. baseline.
Time Frame
Baseline, post-intervention (3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Capable of giving informed consent Fluent in English Currently employed sworn law enforcement officer working in the Dane County Sheriff's Office, Madison Police Department, or University of Wisconsin-Madison Police Department. Exclusion Criteria: Extensive prior experience in meditation practice, or previous completion of Mindfulness-Based Stress Reduction, Mindfulness-Based Resilience Training, or a substantively similar meditation training program A work schedule that precludes one from committing to regular participation in the 8-week training program Command staff working in a supervisory role
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel W Grupe, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Healthy Minds, University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53703
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34539521
Citation
Grupe DW, Stoller JL, Alonso C, McGehee C, Smith C, Mumford JA, Rosenkranz MA, Davidson RJ. The Impact of Mindfulness Training on Police Officer Stress, Mental Health, and Salivary Cortisol Levels. Front Psychol. 2021 Sep 3;12:720753. doi: 10.3389/fpsyg.2021.720753. eCollection 2021.
Results Reference
derived
PubMed Identifier
34377216
Citation
Chen S, Grupe DW. Trait Mindfulness Moderates the Association Between Stressor Exposure and Perceived Stress in Law Enforcement Officers. Mindfulness (N Y). 2021;12(9):2325-2338. doi: 10.1007/s12671-021-01707-4. Epub 2021 Aug 5.
Results Reference
derived

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Impact of Mindfulness Training on Stress-related Health Outcomes in Law Enforcement

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