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

Inflammation Clinical Trial

Official title:

The Impact of Mindfulness-Based Resilience Training on Stress-Related Biological, Behavioral, and Health-Related Outcomes in Law Enforcement Officers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03488875
• Other study ID #: 2017-1529
• Secondary ID: 2017-R2-CX-0033A
• Status: Completed
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: December 10, 2019

Study information

• Verified date: January 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 10, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Mental Health
• Sleep
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
United States	Center for Healthy Minds, University of Wisconsin-Madison	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	U.S. Department of Justice

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in hair cortisol concentration	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.	Baseline, follow-up (6 months)
Other	Change in restful minutes of sleep	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.	5-7 nights of sleep will be monitored at baseline and post-intervention (3 months)
Other	Change in behavioral pattern separation ability	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".`	Baseline, post-intervention (3 months)
Other	Change in mood and anxiety symptoms	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.	Baseline, post-intervention (3 months)
Other	Change in total PTSD symptoms	Change in total PTSD symptoms from the PTSD Checklist for DSM-5 at post-intervention (3 months) vs. baseline	Baseline, post-intervention (3 months)
Other	Change in resting heart rate	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.	Baseline, post-intervention (3 months)
Other	Change in pain interference	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.	Baseline, post-intervention (3 months)
Other	Change in burnout	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.	Baseline, post-intervention (3 months)
Other	Change in work productivity	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.	Baseline, post-intervention (3 months)
Other	Change in good health practices	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.	Baseline, post-intervention (3 months)
Other	Change in self-reported mindfulness	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.	Baseline, post-intervention (3 months)
Other	Change in work-family spillover	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.	Baseline, post-intervention (3 months)
Primary	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.	Baseline, post-intervention (3 months)
Primary	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.	Baseline, post-intervention (3 months)
Secondary	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.	Baseline, post-intervention (3 months)
Secondary	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.	Baseline, post-intervention (3 months)
Secondary	Change in hyperarousal symptoms	Change in hyperarousal symptoms from the PTSD Checklist for DSM-5 at post-intervention (3 months) vs. baseline	Baseline, post-intervention (3 months), follow-up (6 months)
Secondary	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	Baseline, post-intervention (3 months)
Secondary	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.	Baseline, post-intervention (3 months)