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

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ClinicalTrials.gov Identifier: NCT03488875
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : December 17, 2018
Sponsor:
Collaborator:
U.S. Department of Justice
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment Phase
Stress, Psychological Sleep Inflammation Mental Health Behavioral: mMBRT Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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.

Primary Purpose: Prevention
Official Title: The Impact of Mindfulness-Based Resilience Training on Stress-Related Biological, Behavioral, and Health-Related Outcomes in Law Enforcement Officers
Actual Study Start Date : March 6, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: mMBRT
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).
Behavioral: mMBRT
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.
Other Names:
  • Madison Mindfulness-Based Resilience Training
  • MBRT

No Intervention: Waitlist control group
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.



Primary Outcome Measures :
  1. Change in perceived occupational stress [ Time Frame: Baseline, post-intervention (3 months) ]
    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.

  2. Change in diurnal cortisol slope [ Time Frame: Baseline, post-intervention (3 months) ]
    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 :
  1. Change in cortisol awakening response [ Time Frame: Baseline, post-intervention (3 months) ]
    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.

  2. Change in peripheral inflammatory markers [ Time Frame: Baseline, post-intervention (3 months) ]
    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.

  3. Change in hyperarousal symptoms [ Time Frame: Baseline, post-intervention (3 months), follow-up (6 months) ]
    Change in hyperarousal symptoms from the PTSD Checklist for DSM-5 at post-intervention (3 months) vs. baseline

  4. Change in subjective sleep quality [ Time Frame: Baseline, post-intervention (3 months) ]
    Global scores on the Pittsburgh Sleep Quality Index (Buysse et al., 1988) will be compared at post-intervention (3 months) vs. baseline

  5. Change in perceived stress [ Time Frame: Baseline, post-intervention (3 months) ]
    Changes in total scores from the Perceived Stress Scale (10-item version; Cohen et al., 1988) from baseline to 3 months.


Other Outcome Measures:
  1. Change in hair cortisol concentration [ Time Frame: Baseline, follow-up (6 months) ]
    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.

  2. Change in restful minutes of sleep [ Time Frame: 5-7 nights of sleep will be monitored at baseline and post-intervention (3 months) ]
    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.

  3. Change in behavioral pattern separation ability [ Time Frame: Baseline, post-intervention (3 months) ]
    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".`

  4. Change in mood and anxiety symptoms [ Time Frame: Baseline, post-intervention (3 months) ]
    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.

  5. Change in total PTSD symptoms [ Time Frame: Baseline, post-intervention (3 months) ]
    Change in total PTSD symptoms from the PTSD Checklist for DSM-5 at post-intervention (3 months) vs. baseline

  6. Change in resting heart rate [ Time Frame: Baseline, post-intervention (3 months) ]
    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.

  7. Change in pain interference [ Time Frame: Baseline, post-intervention (3 months) ]
    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.

  8. Change in burnout [ Time Frame: Baseline, post-intervention (3 months) ]
    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.

  9. Change in work productivity [ Time Frame: Baseline, post-intervention (3 months) ]
    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.

  10. Change in good health practices [ Time Frame: Baseline, post-intervention (3 months) ]
    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.

  11. Change in self-reported mindfulness [ Time Frame: Baseline, post-intervention (3 months) ]
    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.

  12. Change in work-family spillover [ Time Frame: Baseline, post-intervention (3 months) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03488875


Contacts
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Contact: Daniel W Grupe, PhD 608-263-7572 grupe@wisc.edu

Locations
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United States, Wisconsin
Center for Healthy Minds, University of Wisconsin-Madison Recruiting
Madison, Wisconsin, United States, 53703
Contact: Daniel W Grupe, PhD    608-263-7572    grupe@wisc.edu   
Sponsors and Collaborators
University of Wisconsin, Madison
U.S. Department of Justice
Investigators
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Principal Investigator: Daniel W Grupe, PhD University of Wisconsin, Madison

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03488875     History of Changes
Other Study ID Numbers: 2017-1529
2017-R2-CX-0033 ( Other Grant/Funding Number: National Institute of Justice )
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Inflammation
Stress, Psychological
Pathologic Processes
Behavioral Symptoms