Mindfulness-Based Resilience Training for Aggression, Health, and Stress Among Law Enforcement Officers
Phase: NA
Conditions: Stress, Psychological, Aggression
Sponsor: Pacific University

Study Product Guidelines and Considerations 
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5 November, 2019 
 
 
 
 
 
 
 
FULL PROTOCOL TITLE 
 
Mindfulness-Based Resilience Training for Aggression, 
Stress and Health in Law Enforcement Officers:  
A 3-arm multisite randomized feasibility trial 
 
NCT03784846 
November 5, 2019 
Principal Investigators:   
Michael Christopher, PhD, Professor, Pacific University 
Sarah Bowen, PhD, Associate Professor, Pacific University 
 
Supported by:  
The National Center for Complementary and Integrative Health. Grant 
Number U01AT009841 
 
 
 
 
 
 
 

Study Product Guidelines and Considerations 
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Version 11 
 
 
5 November, 2019 
 
Tool Revision History 
Version Number: 1 
Version Date: 11/13/2018 
Summary of Revisions Made:  
Version Number: 2 
Version Date: 12/21/2018 
Summary of Revisions Made: 
Version Number: 3 
Version Date: 1/14/2019 
Summary of Revisions Made:  
Version Number: 4 
Version Date: 2/20/2019 
Summary of Revisions Made: Timing of cortisol collection, revised lab stress task and addition 
of attention task (SART), added description of Portland research space, adjusted SME and 
MBRT session length, blood pressure monitor equipment change. 
Version Number: 5 
Version Date: 3/6/2019 
Summary of Revisions Made: Added stressor task to assessment flowchart and revised SME 
and MBRT session language. 
Version Number: 6 
Version Date: 3/12/2019 
Summary of Revisions Made: Corrected typos to content added in Version 5. 
Version Number: 7 
Version Date: 6/3/2019 
Summary of Revisions Made: Updated study locations, removed cortisol awakening response, 
added two new assessments (MAIA II and PASA), updated procedures for stress challenge 
including repeating measure at 3-month follow-up visit. Added Project Coordinator, Janae 
Taylor to study roster. 
Version Number: 8 
Version Date: 6/18/2019 
Summary of Revisions Made: removed “informed” from verbal consent for phone screening, and 
removed “with saliva collection aid” from description of cortisol measurement. 
Version Number: 9 
Version Date: 7/15/2019 

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Summary of Revisions Made: Updated list of self-report measures and schedule of evaluations, 
added “Screen” box to participant flow diagram, added website, removed full-time and active 
status eligibility requirements (part-time LEOs may be eligible and “active status” is redundant 
with being and LEO), added description of the Social Evaluative Cold Pressor Task and saliva 
collection procedures, revised focus group question about saliva collection procedures. 
Version Number: 10 
Version Date: 8/27/2019 
Summary of Revisions Made: Revised inclusion criteria to add “…at the rank of Sergeant or 
below,” extended assessment windows from 2 weeks to 3 weeks (for pre-, post-, 3-month 
followup, and 6-month followup), added Omron HEM-907XL to calibrate blood pressure at all 
assessment visits.  
 
Version Number: 11 
Version Date: 11/5/2019 
Summary of Revisions Made: Added statement that if needed, we will recruit officers from 
Greater Portland and Albuquerque Metro areas in addition to Albuquerque Police Department 
and Portland Police Bureau; revised randomization allocation ratio from 1.5:1:1 to 2:1.5:1 for 
MBRT, SME, and NIC conditions, respectively; updated saliva collection timeframes. 
 

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TABLE OF CONTENTS 
Page 
FULL PROTOCOL TITLE ......................................................................................................... 1 
Tool Revision History ................................................................................................................. 2 
TABLE OF CONTENTS ............................................................................................................. 4 
STUDY TEAM ROSTER........................................................................................................... 7 
PARTICIPATING STUDY SITES ............................................................................................ 7 
PRÉCIS ....................................................................................................................................... 8 
1. STUDY OBJECTIVES ........................................................................................................... 10 
1.1 
Primary Objective ......................................................................................................... 10 
1.2 
Secondary Objectives.................................................................................................... 11 
2. BACKGROUND AND RATIONALE .................................................................................. 11 
2.1 
Background on Condition, Disease, or Other Primary Study Focus ............................ 11 
2.2 
Study Rationale ............................................................................................................. 12 
3. STUDY DESIGN ..................................................................................................................... 13 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS .............................................. 17 
4.1 
Inclusion Criteria .......................................................................................................... 17 
4.2 
 Exclusion Criteria ........................................................................................................ 18 
4.3 
Study Enrollment Procedures ....................................................................................... 18 
5. STUDY INTERVENTIONS .................................................................................................. 19 
5.1 
Interventions, Administration, and Duration ................................................................ 19 
5.2 
Handling of Study Interventions ................................................................................... 20 
5.3 
Concomitant Interventions ............................................................................................ 20 
5.3.1 
Allowed Interventions ........................................................................................... 20 
5.3.2 
Required Interventions .......................................................................................... 20 
5.3.3 
Prohibited Interventions ........................................................................................ 20 
5.4 
Adherence Assessment ................................................................................................. 20 
6. STUDY PROCEDURES ........................................................................................................ 21 
6.1 
Schedule of Evaluations ................................................................................................ 21 
6.2 
Description of Evaluations ............................................................................................ 23 

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6.2.1 
Screening Evaluation ............................................................................................ 23 
6.2.2 
Enrollment, Baseline, and/or Randomization ....................................................... 24 
6.2.3 
Blinding................................................................................................................. 26 
6.2.4 
Followup Visits ..................................................................................................... 26 
6.2.5 
Completion/Final Evaluation ................................................................................ 29 
7. SAFETY ASSESSMENTS ..................................................................................................... 29 
7.1 
Specification of Safety Parameters ............................................................................... 30 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 30 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 30 
7.4 
Reporting Procedures .................................................................................................... 31 
7.5 
Followup for Adverse Events ....................................................................................... 31 
7.6 
Safety Monitoring ......................................................................................................... 31 
8. INTERVENTION DISCONTINUATION............................................................................ 31 
9. STATISTICAL CONSIDERATIONS .................................................................................. 32 
9.1 
General Design Issues ................................................................................................... 32 
9.2 
Sample Size and Randomization .................................................................................. 32 
9.2.1 
Treatment Assignment Procedures ....................................................................... 33 
9.3 
Definition of Populations .............................................................................................. 34 
9.4 
Interim Analyses and Stopping Rules ........................................................................... 35 
9.5 
Outcomes ...................................................................................................................... 36 
9.5.1 
Primary Outcome .................................................................................................. 36 
9.5.2 
Secondary Outcomes ............................................................................................ 37 
9.6 
Data Analyses ............................................................................................................... 37 
10. DATA COLLECTION AND QUALITY ASSURANCE .................................................. 40 
10.1 
Data Collection Forms .................................................................................................. 40 
10.2 
Data Management ......................................................................................................... 40 
10.3 
Quality Assurance ......................................................................................................... 40 
10.3.1 
Training ................................................................................................................. 40 
10.3.2 
Quality Control Committee................................................................................... 40 
10.3.3 
Metrics .................................................................................................................. 40 
10.3.4 
Protocol Deviations ............................................................................................... 41 
10.3.5 
Monitoring ............................................................................................................ 41 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................... 41 
11.1 
Institutional Review Board (IRB) Review .................................................................... 41 
11.2 
Informed Consent Forms .............................................................................................. 41 

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11.3 
Participant Confidentiality ............................................................................................ 42 
11.4 
Study Discontinuation ................................................................................................... 42 
12. COMMITTEES..................................................................................................................... 42 
13. PUBLICATION OF RESEARCH FINDINGS .................................................................. 42 
14. REFERENCES ...................................................................................................................... 42 
15. SUPPLEMENTS/APPENDICES ........................................................................................ 52 
I. Procedures Schedule 
II. Informed Consent Form Template 
III. Other (add as many appendices as necessary) 

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STUDY TEAM ROSTER  
Pacific University 
Michael Christopher, PhD, 503-327-1563, mchristopher@pacificu.edu 
Sarah Bowen, PhD, 206-778-7080, bowen@pacificu.edu 
Matthew Hunsinger, PhD, 503-352-3612, matthewh@pacificu.edu 
Lt. Richard Goerling, 503-501-0662, rgoerling@pacificu.edu 
Janae Taylor, 503-352-2408, janae.taylor@pacificu.edu 
University of New Mexico 
Katie Witkiewitz, PhD, 505-277-5953, katiew@unm.edu 
Oregon Health & Science University 
Barry Oken, PhD, 503-494-7772, oken@ohsu.edu 
Albuquerque Police Department/University of New Mexico 
Nils Rosenbaum, MD, 505-924-6018, nrosenbaum@cabq.gov 
 
PARTICIPATING STUDY SITES 
Pacific University 
MPI: Michael Christopher, PhD, 503-327-1563, mchristopher@pacificu.edu 
MPI: Sarah Bowen, PhD, 206-778-7080, bowen@pacificu.edu 
University of New Mexico 
Co-I: Katie Witkiewitz, PhD, 505-277-5953, katiew@unm.edu 
Oregon Health & Science University 
Co-I: Barry Oken, PhD, 503-494-7772, oken@ohsu.edu 
Portland Police Bureau 
 
      Liaison/Co-I: Lt. Rich Goerling, 503-501-0662, rgoerling@pacificu.edu 
Albuquerque Police Department/University of New Mexico 
Co-I: Nils Rosenbaum, MD, 505-924-6018, nrosenbaum@cabq.gov 
 
 
 
 

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PRÉCIS  
Mindfulness-Based Resilience Training for Aggression, Stress and Health in Law 
Enforcement Officers 
 
Objectives  
The primary objective of the study is to identify, optimize and refine best clinical and research 
practices to ensure success in a future multisite efficacy trial assessing effects of Mindfulness-
Based Resilience Training (MBRT) versus attention control, Stress Management Education 
(SME), and a no intervention control on physiological, behavioral, and psychological outcomes 
among LEOs. The study’s specific primary objectives are to ensure efficiency, optimization and 
fidelity of all procedures across two study sites. 
 
1: Enhance efficiency of recruitment, engagement, and retention across sites  
1.1 Refine recruitment methods used in our recent R21 trial to maximize inclusion of female 
and ethnic minority LEOs 
1.2 Enhance previous R21 procedures to ensure ≥ 80% LEO retention throughout intervention 
and follow-up phases 
1.3 Enhance participant treatment engagement and compliance to treatment protocol 
1.4 Identify recruitment and retention barriers, and appropriately refine procedures  
2: Ensure fidelity and equivalence of lab, assessment, and data management procedures 
across sites 
2.1 Assess and improve efficiency of data collection and procedures for on-the-job LEO 
excessive use of force (e.g., aggressive drawing and discharge of weapons, vehicle rams, 
and illegal takedowns)  
2.2 Confirm acceptability of self-report (resilience, aggression, burnout, depression, suicidal 
ideation, trauma, and alcohol misuse) and stress biomarker (HR, BP, Cortisol and sAA) 
data collection 
2.3 Hone critical incidents stress challenge procedures to ensure physiological biomarker 
responsiveness 
2.4 Train relevant study staff in REDCap and confirm compliance with Good Clinical Practice 
procedures 
3: Optimize intervention training procedures and ensure fidelity to intervention protocols 
across sites   
3.1 Refine training and supervision procedures for clinical interventionists to enhance 
intervention fidelity 
3.2 Hone session coding procedures and adapt the Adherence and Competence Scale for use 
with both MBRT and SME to ensure fidelity and equivalence across sites and the two 
active interventions  
4: Assess participant experience and optimize outcome measures across sites 
4.1 Qualitatively evaluate feasibility, acceptability, and impact of assessments, protocol, and 
interventions  
4.2 Confirm sensitivity, responsiveness to change, and psychometric soundness of outcome 
measures 
Design and Outcomes   

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The study will use a randomized multi-site (Portland, Albuquerque) clinical trial assessing 
feasibility and across-site equivalence of all study procedures. Three study arms include MBRT, 
an attention control (SME), and a no-intervention control (NIC). Outcomes include 
physiological, behavioral, and psychological indices of officer wellbeing, resilience, and 
excessive use of force in law enforcement officers.  
Participants will complete baseline, post-intervention, and 3- and 6-month follow-up 
assessments. Assessments include self-report measures, saliva cortisol collection, physiological 
measures (heart rate, respiration rate, and blood pressure), a computerized attention task, and a 
stressor test. A subsample of participants will participate in a post-intervention focus group. 
Twelve-month departmental excessive use of force data will be collected from police department 
databases, and will involve neither direct participant interaction nor compensation. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Interventions and Duration  
Participants in all 3 arms will be involved in the study for baseline data collection, collected 
within 14 days of the start of the intervention period, followed by an 8-week intervention period 
Screen: Inclusion/exclusion criteria, informed consent 
MBRT 
(n=47) 
SME 
(n=35) 
NIC 
(n=22) 
Baseline: Self Report, Physio (HR, RR, BP), Cortisol, 
sAA Attention task, Stressor test 
Postcourse: Self Report, Physio (HR, BP), Cortisol, 
sAA, Attention task, Stressor test 
8-Week Intervention period 
3-Month Follow Up: Self Report, Physio (HR, BP), 
Cortisol, sAA, Attention task, Stressor test 
6-Month Follow Up: Self Report, Attention task 
12-Month Follow Up: BlueTeam Departmental 
Record Data 
Focus Groups:  
(MBRT=22; 
SME=12; NIC=10) 
 
Enroll: 104 LEOs 

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during which participants randomized to MBRT or SME will receive an active intervention. 
Participants in the NIC condition will not receive any intervention. There will then be a 6-month 
follow-up period (± 7 days), totaling 7.75 - 8.25 months total of study involvement. Although 
12-month data are collected via police department (BlueTeam) databases, participant 
involvement ends after the 6-month follow-up assessment point. 
Sample Size and Population  
We will recruit 104 law enforcement officers (52 at each study site). Using a 2:1.5:1 
randomization allocation ratio for MBRT, SME, and NIC conditions, respectively, across two 
sites, 47 participants will be randomized to MBRT (~24 at each site); 35 to SME (~17 at each 
site); and 22 to NIC (11 at each site). Participants will be stratified by gender to ensure 
equivalent gender representation across conditions.  
Using an approximate 2:1:1 ratio, a random sample of 15, 8, and 7 MBRT, SME, and NIC 
participants, respectively, will be invited to participate in focus groups at each site after the post-
course assessment. Purposeful sampling will be used to ensure adequate gender representation in 
all conditions. We anticipate approximately 11 MBRT, 6 SME, and 5 NIC participants will agree 
to attend for a total of 44 (22 MBRT, 12 SME, 10 NIC).  
1. STUDY OBJECTIVES 
1.1 Primary Objective 
Objective 1: Enhance efficiency of recruitment, engagement, and retention across sites.  
We will successfully enroll 52 LEOs per site, with an across-site average of 20% female and 
35% racial/ethnic minority participants; 85% of participants will attend ≥ 6 MBRT or SME 
sessions (i.e., treatment completer), and complete 75% of assigned homework. Based on 80% 
retention at 3 months in the recent R21, enhanced retention efforts will result in 80% at 6 
months.  
Per NCCIH SARP guidelines, we will gauge accrual and retention by accrual of ≥80% but no 
higher than 150% of benchmark number at a given time point, study initiation delay of ≤1 
accrual reporting period (~4 months), and actual loss to follow-up rate ≤20%. 
 
Objective 2: Ensure fidelity and equivalence of lab, assessment, and data management 
procedures across sites. 100% of staff will complete trainings in research ethics, an NIH Good 
Lab Practice course, and all assessment and lab procedures. Throughout the study, there will be 
≤5% rate data procedural errors, tracked in REDCap (same procedure used in R21 study). Based 
on the R21 study, we expect ≤15% missing data due to omitted or refused completion of 
measures from active participants. Collection of self-report measures will be acceptable to LEOs 
at both sites, i.e., all assessments will be completed in the allotted time, assessment burden will 
be acceptable, and questionnaire items will be relevant and acceptable (≥75% of LEOs rate 
assessment protocol as “reasonable” or “very reasonable” in content, clarity and time burden). 
We will obtain departmental excessive use of force (BlueTeam) data for 100% of participants at 
both sites in designated period (1 month to assemble pre-baseline, and 1 month to assemble at 
12-month follow-up). Biweekly reviews will yield 100% adherence to data management protocol 
at both sites. 
 

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Objective 3: Optimize intervention training procedures and ensure fidelity to intervention 
protocols across sites. All study MBRT and SME interventionists will complete intensive 
clinical trainings, demonstrate 90% fidelity on Adherence and Competence scales, and 
subsequently maintain ≥85% overall fidelity (including session content coverage, presence of 
main themes, and global skills). Interrater reliability between all coders will be ≥.75, which is an 
established criterion for excellent reliability. 
 
Objective 4: Assess participant experience and optimize outcome measures across sites. 
Well-developed content themes with data saturation emerging from focus groups will provide 
information on acceptability, impact of assessments, protocol and intervention fidelity, and 
equivalence of these markers across sites. Benchmark sensitivity and responsiveness values will 
determine the most sensitive and responsive measures relative to all study outcomes, versus a 
significance testing approach in which standardized/conventional threshold values are used to 
make decisions regarding significance. Sensitivity and responsiveness information will 
determine which outcomes are most impacted by MBRT for retention in a future full-scale multi-
site efficacy trial. Benchmarks for equivalence across sites will be evidenced by: a) qualitative 
themes that suggest experiential continuity across sites, and b) equivalence in outcome measure 
response distributions, reliability estimates, and intraclass correlations. 
 
1.2 Secondary Objectives 
Our primary objectives include assessing sensitivity and responsiveness of all study procedures 
and assessments. We will thus not consider any objectives to be primary or secondary. 
2. BACKGROUND AND RATIONALE 
2.1 Background on Condition, Disease, or Other Primary Study Focus 
Policing is one of the most highly stressful occupations.3, 4 Unpredictable exposures to violence, 
chronic stress, job dissatisfaction, and expectations for optimal performance lead to an intensive 
work environment.5 Stress-impaired law enforcement officers (LEOs) are more likely to be 
aggressive toward suspects and use excessive force.6, 7 LEO occupational stress has also been 
linked to disproportionately high rates of depression and suicide,8 PTSD,9 burnout,10 and alcohol 
misuse.11 Collectively, stress inherent to policing exacts enormous personal, financial, and 
societal costs. 
Bureau of Justice Statistics (https://www.bjs.gov) estimates 59.4 million U.S. residents age 16 or 
older had one or more face-to-face contacts with police in 2011 (most recent year data were 
available). Among them, an estimated 2.3 million experienced threat or use of force by police, 
and nearly 75% of those described it as excessive. Appropriate use of force in acutely stressful 
situations is an essential component to safe and successful policing. However, physiological 
stress responses to acute LEO critical incidents can influence behavior and impact the outcome 
of the incident.   
Studies on human responses to stressful events demonstrate neuroendocrine markers play an 
important role in physiological reactivity to stress.12, 13 Stress responsiveness is primarily 
regulated by two neuroendocrine axes: the sympathetic adrenomedullary (SAM) and 
hypothalamic-pituitary-adrenocortical (HPA) systems - distinct but interrelated systems designed 

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to help the body mobilize resources to deal with psychosocial and physical challenges that can be 
measured across different time points (e.g., acute, awaking profiles, chronic). Acute 
psychological stress quickly activates the SAM axis, eliciting release of catecholamines such as 
noradrenaline and adrenaline, resulting in elevation of heart rate (HR), blood pressure (BP) and 
salivary alpha amylase (sAA). Dysfunction within the SAM and HPA systems among distressed 
and/or chronically stressed populations is thoroughly documented, including in LEOs,17, 18 and is 
indicated by exaggerated or blunted reactivity to stressors and/or prolonged recovery time.19, 20  
 
Regular exposure to acute and chronic stressors, such as organizational challenges, and exposure 
to violence and potential harm, contribute to elevated rates of LEO mental illness. LEOs 
experience, on average, over three traumatic events for every six months of service,21 with 
annual PTSD prevalence rates as high as 19%,22 compared to an estimated 3.5% prevalence in 
U.S. adults. High trauma-exposed LEOs are more likely to discharge their firearm during critical 
incidents,23, 24 report higher rates of job dissatisfaction and burnout than most other 
occupations,25 and burnout is associated with aggression and excessive use of force.26, 27 LEOs 
have high rates of alcohol consumption and binge drinking,28 and deaths due to alcohol-related 
liver disease are twice that of the general population.29 LEOs who engage in hazardous drinking 
are four times more likely to commit physical violence against others.30 Rates of depression and 
suicide are up to three times higher than the general public, even with probable underreporting of 
LEO suicide.31  
 
2.2 
Study Rationale 
Programs targeting LEO stress often lack effectiveness, with a focus on post-incident 
intervention instead of prevention. Despite elevated rates of PTSD, burnout, alcohol 
consumption, alcohol-related death, and suicide, and the significant implications of compromised 
officers to the safety of the public, effective LEO trainings and interventions are still lacking. 
The majority of intervention research among LEOs has examined Critical Incident Stress 
Debriefing (CISD),32, 33 described as, “a structured group story-telling process combined with 
practical information to normalize group member reactions to a critical incident…only used in 
the aftermath of a significant traumatic event.” (p. 36) However, authors of a Cochrane Review34 
concluded, “there is no evidence that single session individual psychological debriefing is a 
useful treatment for the prevention of post-traumatic stress disorder after traumatic incidents.” (p. 
2) Although some individual studies report positive effects on specific indices of LEO mental 
health, RCTs, systematic reviews, and meta-analyses have concluded CISD is ineffective and can 
have iatrogenic effects, exacerbating acute stress reactions among LEOs and other first 
responders.35-37 A recent meta-analysis38 examining effectiveness of stress reduction programs 
among LEOs found small effect sizes, and concluded that, “insufficient evidence exists to 
demonstrate the effectiveness of stress management interventions for reducing negative 
physiological, psychological or behavioral outcomes among police officers and recruits.” (p. 
508) 
 
Mindfulness-Based Resilience Training 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. To supplement in-session content and 

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support practice between sessions, MBRT participants will use the iMINDr app, which is 
programmed with exercises and monitoring software, and worksheets to track daily experiences 
and behaviors such as triggers and stress reactions. 
 
Preliminary evidence suggests mindfulness training (MT) is a promising approach for the 
specific risks, challenges and outcome patterns present in the LEO population. MT has strong 
empirical support in lab-based, clinical, and community-based research, evincing outcomes such 
as reduced violence and aggression,39-41 and improved biomarkers of SAM and HPA stress 
reactivity, including HR, BP, cortisol, and sAA.42-46 In a recent study,47 authors concluded 
salutary effects of MT may be most likely in high-stress populations, in which stress is known to 
affect onset or aggravation of poor mental and physical health outcomes. Authors hypothesized 
that MT might “reduce SAM- or HPA-axis reactivity (or normalize dysregulated stress signaling 
in these systems), and subsequently impact stress-related disease-specific biological processes.” 
(p. 405).  
 
MT may regulate how the individual appraises stress, and increase secondary appraisals of 
approach-oriented coping resources, thus reducing stress reactivity. Recent meta-analyses 
support this theory, indicating MT improves common LEO health and risk factors, including 
stress,48, 49 depression and suicidal ideation,49, 50 alcohol misuse,51, 52 trauma,49, 53 and burnout, 54, 
55 and increases psychological resilience.56, 57 MT has been shown to be feasible and to lead to 
improved health outcomes among several high-stress populations, such as military personnel,58, 
59 physicians,60, 61 firefighters,62 and inner-city teachers.63 Resilience training has also been 
shown to improve the capacity to adapt to stress and improve outcomes in high-stress 
populations.60, 64 These approaches often focus on skills training to buffer against ongoing acute 
and chronic stressors.65, 66 Several pilot studies have shown LEO resilience-enhancing programs 
improve HR, BP, sAA and behavioral performance in live or simulated critical incident 
simulation tasks.67-70 Based on work with military and first-responder populations, Jha and 
colleagues71 recently proposed a conceptual model of risk reduction among high-stress 
professions, in which mindfulness and resilience synergistically impact health and risk factors, 
such as those common among LEOs. 
 
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. To supplement in-
session content, and to match amount and format of assigned homework in the MBRT condition, 
SME participants will also use the iMINDr app, programmed with audio content and monitoring 
software. 
3. STUDY DESIGN 
The study will use an Individually-Randomized Group Treatment (IRGT) design, which will 
entail randomizing individuals, not groups, to an intervention that will be delivered to groups of 
Law Enforcement Officers (LEOs) An IRGT design is typically used when examining an 
intervention that is intended to be delivered to individuals or implemented at an individual level 
versus a Group/Cluster-randomized (GR) design that is used when the intervention is intended to 
be delivered and implemented at a group level.72 MBRT is delivered as a group, but the 

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meditation practice is implemented at an individual level. Therefore, an IRGT design is 
preferable over a GR design, which is consistent with the use of an IGRT design in randomized 
controlled trials (RCTs) examining the efficacy of mindfulness-based interventions in the extant 
literature.73, 74 An IRGT design will allow us to assess the impact of MBRT on individual LEOs. 
 
The units of assignment and observation in the proposed study will be at the individual level 
since MBRT randomization and measurement will occur at an individual LEO level. Given that 
our primary objectives include assessing the sensitivity and responsiveness of all self-report, 
physiological, and behavioral outcomes, we will not consider any of our outcome measures to be 
primary or secondary measures. Our goal is to identify which outcomes are most impacted by 
MBRT, which will guide us in choosing primary and secondary outcomes in a future fully-
powered efficacy RCT. 
 
The target population for our study is LEOs working in urban settings in the United States. LEOs 
will be recruited from Portland Police Bureau (PPB) and Albuquerque Police Bureau (APB). 
PPB employs 966 full-time, active duty officers, serving approximately 603,106 citizens in the 
Greater Portland Metropolitan Area; women and racial/ethnic minorities represent 16% and 16%, 
respectively. APD employs 921 full-time, active duty officers, serving approximately 907,301 
citizens in the Greater Albuquerque Metropolitan Area; women and racial/ethnic minorities 
represent 16% and 47%, respectively. We will make concerted efforts to recruit a target final 
sample comprising ≥ 16% women and ≥ 16% racial/ethnic minorities in Portland, and ≥ 16% 
women and ≥ 35% racial/ethnic minorities in Albuquerque. 
 
We will recruit 104 participants (52 participants at each site). Using a 2:1.5:1 randomization 
allocation ratio for MBRT, SME, and NIC conditions, respectively, across the two study sites, 47 
participants will be randomized to MBRT (~24 at each site); 35 to SME (~17 at each site); and 
22 to NIC (11 at each site). Our sample size is based on feasibility trial recommendations 
suggesting 12-25 participants per arm to optimize estimation of group means and variability 
without oversampling in terms of diminishing returns in parameter estimation, and to provide 
reasonably precise information in terms of confidence intervals around retention rates. 
 
If we do not get an adequate response from either of the two departments, we will expand 
recruitment to neighboring police departments in the Greater Portland Metro and/or Albuquerque 
Metro areas. 
At the Oregon study site, training and data collection will take place in the Pacific University 
Health and Resilience Center (PU-HRC) in Portland, OR. The building has four individual 
offices, two psychophysiology assessment rooms, a large conference/intervention room,  and a 
space for secure storage of data.  Drs. Christopher and Bowen, and study coordinator Taylor each 
have dedicated individual offices in this building and their Research Assistants have continuous 
and protected access to these offices along with dedicated student space.  
 
At the New Mexico study site, training and data collection will take place at The Department of 
Psychology at the University of New Mexico (UNM). 
 
Assessment and intervention locations at both study sites were carefully chosen, in collaboration 
with the corresponding police departments, to ensure low threshold accessibility. Per police 

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department-recommended criteria, locations are central, accessible via public transportation, 
have parking options, and do not have signage that indicates mental health or addiction services, 
which can be a barrier for law enforcement participation.  
 
Enrollment for the study will take place during Year Two of the grant from Month 2 through 
Month 8. The first phase of baseline data collection will occur during Month 4 of Year 2, directly 
preceding the beginning of MBRT and SME training for the first cohort of participants in 
Months 4 and 5. The second phase of baseline data collection will occur during Year Two in 
Month 8, directly preceding the beginning of MBRT and SME training for the second cohort of 
participants in Months 8 and 9.  
 
The first phase of post-intervention data collection will occur during Year 2, Month 8, directly 
following the end of MBRT and SME training for the first cohort of participants; the second 
phase of post-intervention data collection will occur in Year 2, Month 12, directly following 
completion of MBRT and SME training for the second cohort of participants. Qualitative data 
collection (i.e., focus groups) for each training cohort will occur during the same months as post-
intervention data collection.  
 
The first phase of 3-month follow-up data collection (first training cohort) will occur during Year 
2 Month 10; the second phase of 3-month follow-up data collection (second training cohort) will 
occur during Year 3, Month 2. The first phase of 6-month follow-up data collection (first training 
cohort) will occur during the Year 3, Month 2; the second phase of 6-month follow-up data 
collection (second training cohort) will occur during the Year 3, Month 6. The first phase of 12-
month follow-up data collection (first training cohort) will occur during Year 3, Month 8; the 
second phase of 12-month follow-up data collection (second training cohort) will occur during 
the Year 3, Month 12. 
 
MBRT will be delivered in 8 weekly 2-hour sessions with an extended 6-hour class in weeks 1 
and 7. MBRT contains experiential and didactic exercises including body scan, sitting and 
walking meditation, mindful movement and discussions. We have developed and refined MBRT 
based on focus group data from pilot research and feedback from our R21 trial (R21AT008854); 
content and language has been altered to be more relevant to LEOs, and there is greater emphasis 
on managing stressors inherent to police work, including critical incidents, job dissatisfaction, 
public scrutiny, and interpersonal, affective, and behavioral challenges. To supplement in-session 
content and support practice between sessions, MBRT participants will use the iMINDr app, 
which is programmed with exercises and monitoring software, and worksheets adapted from 
Mindfulness-Based Relapse Prevention75 to track daily experiences and behaviors such as 
triggers and stress reactions. MPI Bowen will co-lead the MBRT intervention at the Oregon 
study site with an advanced graduate student; a different interventionist will lead the MBRT 
intervention at the New Mexico study site with the assistance of an advanced graduate student. 
Co-Is Goerling and Witkiewitz will collaborate with Bowen to prepare for the training at the 
Oregon study site; Goerling, Witkiewtiz, and Bowen will oversee MBRT interventionist training 
at the New Mexico study site. Goerling co-developed MBRT, and is an expert in MBIs with first 
responders; Bowen and Witkiewitz have facilitated, trained and supervised MBIs, and have 
collaborated on multiple MBI-related NIH trials. 
 

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Our active control group will be a Stress Management Education (SME) training, which is 
designed as an active control condition for MBSR trials.76 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. It is an 8-week, 2.5-hour class with weekly homework (amount matched to MBRT), one 
extended 6-hour session, and gentle movement exercises. Dr. Hoge (SME developer) will 
provide input and support to ensure interventionists are trained to fidelity. Training will be 
conducted by trainers approved by Dr. Hoge, who has experience conducting SME and training 
interventionists. MPI Christopher, a licensed clinical psychologist with experience facilitating 
stress management groups, will oversee SME training with support from Dr. Hoge. 
 
MBRT and SME groups will be led by separate interventionists, with at least masters level 
training in mental health or a related field, and matched for level of education and experience. 
MBRT interventionists will have previous training in and experience with MBRT or related 
interventions (e.g., MBSR, MBCT or MBRP), and will undergo intensive training, weekly 
clinical supervision, and regular meetings with MPIs to discuss fidelity and other clinical issues. 
Drs. Christopher, Bowen, and Witkiewitz are clinical psychologists with combined knowledge of 
psychoeducational protocols, MBIs, first responder populations, trauma, substance abuse, and 
other psychosocial outcomes. Given the importance of internal validity of interventions in RCT 
research, careful attention will be given to intervention adherence and consistency across sites, 
with all sessions being audio-recorded. Under the supervision of Dr. Christopher, Dr. 
Witkiewitz, and consultant Hoge, advanced graduate students at both sites will review four 
randomly selected audio-recorded sessions from each MBRT cohort to assess intervention 
fidelity, adapting the MBRP Adherence and Competence measure used in previous trials.77 Drs. 
Christopher, Bowen, and Witkiewitz, as well as consultant Hoge will do the same for each SME 
cohort. Drs. Christopher, Bowen and Witkiewitz will provide weekly supervision to all 
interventionists to ensure fidelity and minimize drift. Participants in the NIC condition will not 
engage in a training; therefore, the administration of this group will only entail scheduling and 
meeting NIC participants for data collection. 
Following baseline assessment, study staff not involved in data collection will randomly assign 
participants to a condition using SPSS and REDCap, stratifying for gender and using a 
permuted-block randomization procedure frequently used in mindfulness-based treatment trials78, 
79 to ensure balance within strata and across arms. The study statistician will create an allocation 
table using SPSS and upload it to REDCap, which study staff will use to implement the 
randomization procedure. Participants will be randomly assigned using a 2:1.5:1 ratio 
respectively (MBRT = 47; SME = 35; NIC = 22). Randomization will occur separately at each 
site to ensure equal ratios at both sites across the three trial arms. Since we are randomizing at 
each study site and stratifying for gender, study site and gender will become non-ignorable 
clusters. In addition, participants in the MBRT groups will receive the training from different 
interventionists across sites; the same will be the case for SME participants. Therefore, we will 
adjust for study site and gender in our statistical models to avoid a deviation in our type I error 
rate from .05.80 Given that there will be covariance between study site and interventionist, and 
considering the size of our sample, we will include study site but not interventionist as a 
covariate in our statistical models. In addition, since including gender and study site as covariates 
in our statistical models will effectively decrease the sample size even further, we will conduct 
sensitivity and responsiveness to change analyses with and without covariates to ensure all 

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inferential analyses can be conducted, and will compare the results between models with and 
without covariates to identify potential Type II Errors in models with covariates included. 
 
Blinding will not be able to occur for participants since they will know their group assignment 
upon completing baseline assessment. We will, however, compartmentalize study staff to 
particular tasks and blind them to all other study components. Study staff will be involved in one 
of the following categories of activities and will not be involved in activities in any other 
category: design and analysis (i.e., designing the trial, overseeing design implementation, and 
analyzing trial data), intervention implementation (i.e., interventionist training, intervention 
implementation, and intervention fidelity monitoring), enrollment and randomization (using 
REDCap to randomize participants to trial arms and informing participants of their group 
assignment), recruitment (implementing recruitment, tracking participant enrollment and 
demographic information, maintaining contact with participants to schedule data collection 
appointments), and data collection (quantitative and qualitative data collection). Only study staff 
involved in enrollment and randomization activities will have access to both participant names 
and unique ID codes. This compartmentalization will create blinding for study staff in that those 
designing the trial and analyzing data will not be interacting with participants, involved in trial 
interventions, or have access to participant names; study staff interacting with participants in the 
interventions will not be involved in collecting or analyzing outcome data and will not have 
access to unique ID codes; study staff involved in setting up data collection appointments will be 
blinded to participant group assignment; study staff involved in collecting quantitative data will 
be blinded to participant group assignment as well as participant names (study staff involved in 
quantitative data collection will have access to unique ID codes); and study staff involved in 
qualitative data collection will be blinded to unique ID codes. (Due to the need to obtain 
qualitative information about participants’ experiences in the SME and MBRT arms, we are 
unable to blind study staff involved in qualitative data collection to group assignment). 
 
The study will be implemented at both sites – with all training, recruiting, randomization, etc. 
completed in parallel at both sites. Overall design and direction of the protocol will reside in 
Oregon, and processing of cortisol will be centralized at Salimetrics (State College, PA). 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
4.1 Inclusion Criteria 
LEOs will be recruited from PPB and APD. We will over recruit for a target final sample across 
sites of 20% women and 35% racial/ethnic minorities. 
 
Eligible participants must: 1) be 21-65 years old (age limitations for both police departments); 2) 
demonstrate English fluency; 3) be a sworn LEO at the rank of Sergeant or below; 4) agree to 
random assignment to condition; and 5) be willing to complete assessments at multiple time 
points and attend intervention groups.  

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4.2  Exclusion Criteria 
Individuals will be excluded from participation if they: 1) have participated in MBSR, MBRT or 
a similar mindfulness course, 2) score in the severe range on brief screening measures of 
depression, suicidal ideation, alcohol use, or PTSD, or 3) are unable or unwilling to give written 
informed consent. 
 
4.3 Study Enrollment Procedures  
Recruitment. LEOs will be recruited from PPB and APD. PPB employs 966 full-time, active 
duty officers, serving approximately 603,106 citizens in the Greater Portland Metropolitan Area; 
women and racial/ethnic minorities represent 16% and 16%, respectively. APD employs 921 
full-time, active duty officers, serving approximately 907,301 citizens in the Greater 
Albuquerque Metropolitan Area; women and racial/ethnic minorities represent 16% and 47%, 
respectively. We will over recruit for a target final sample across sites of 20% women and 35% 
racial/ethnic minorities (see Inclusion Enrollment Report).  
 
In collaboration with human resources staff at PPB and APD, we will recruit 104 LEOs (52 per 
site) for study participation, conducted via: 1) 10-15 minute recruitment sessions, 2) emailed 
invitations sent to all eligible LEOs, 3) informational website and flyers posted at PPB and APD 
facilities, and 4) community-based police organization leadership. We used similar recruitment 
methods for our R21 study and met recruitment goals. Co-I’s Goerling and Rosenbaum will 
oversee recruitment at PPB and APD, respectively. Recruitment will include information about 
interventions, assessed outcomes, concordance between community and investigator goals, and 
research team contact information. Interested individuals will voluntarily contact the research 
team by phone for eligibility screening. They will be informed of study purpose, eligibility 
criteria and randomization process, and will provide verbal consent for a brief phone screening. 
If the officers and research staff believe the study may be a good fit, the officers will be 
scheduled for an in-person screening visit where they will provide written informed consent and 
screen for eligibility criteria. Eligible LEOs will complete the individual baseline assessments 
immediately after the in-person screening and consenting process.  The screening and baseline 
visits will be completed at the PU-HRC (Portland) or UNM (Albuquerque).  
 
Screening Log. Interested individuals will be tracked using REDCap. Data collected will include 
reasons for ineligibility and for non-participation of eligible candidates. 
 
Informed Consent. Study staff will obtain written informed consent from all participants prior to 
baseline data collection. The consent form will include information about randomization, release 
of information (including data from PPB and APD databases), researchers’ responsibilities 
regarding records collected, DHHS certificate of confidentiality, registration with 
clinicaltrials.gov, and permission to audio-record sessions. 
 
Randomization. Study staff not involved in data collection will randomly assign participants to 
condition using SPSS and REDCap, stratifying for gender, using a permuted-block 
randomization procedure frequently used in MT trials to ensure balance within strata and across 

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groups. The study statistician will create an allocation table using SPSS, and upload it to 
REDCap, which will be used to implement the randomization procedure.  
 
Participants will be assigned using a 2:1.5:1 ratio (MBRT = 47; SME = 35; NIC = 22), allowing 
more robust evaluation of measure sensitivity and responsiveness as well as more accurate 
parameter estimation for the MBRT group. Randomization will occur separately at each site to 
ensure equal ratios at both sites across the three arms.  
 
Participants will be notified of group assignment by a study team member. Participants assigned 
to MBRT and SME conditions will receive information regarding course structure, dates/times, 
and class format, and provided information on assessment timeline, reminder calls they will 
receive, and contact information for the research team. Participants assigned to SME or NIC will 
be offered an opportunity to attend an MBRT course after the final 12-month follow-up 
collection of departmental excessive use of force data.  
5. STUDY INTERVENTIONS  
5.1 Interventions, Administration, and Duration  
Both MBRT and SME will include psychoeducation, gentle movement exercises focused on 
stress reduction and fitness, and weekly homework assignments, and will be matched for time 
and assigned homework.  
 
MBRT will be delivered in groups of 10 to 13 law enforcement officers, in 8 weekly sessions of 
2 hours each, with the exception of weeks 1 and 7 which are extended 6-hour classes, for a total 
of 24 intervention hours. The extended session, modeled after MBSR, is intended to provide an 
immersive training experience. The session will contain a series of mindfulness practices, 
including body scan, mindful movement, and walking and breath-focused meditations. The 
session will focus primarily on formal mindfulness practices, in contrast to inclusion of 
discussion and psychoeducational components contained in other MBRT sessions.  
 
MBRT and SME intervention groups will be held in reserved rooms able to accommodate up to 
25 people - specifically, the Psychology Research Lab in Portland, and at UNM Department of 
Psychology in Albuquerque. MPI Bowen and Co-Is Goerling and Witkiewitz will oversee 
MBRT interventionist training. Goerling co-developed MBRT, and is an expert in MBIs with 
first responders; Bowen and Witkiewitz have facilitated, trained and supervised MBIs, and have 
collaborated on multiple MBI-related NIH trials.  
SME will be delivered as a weekly, 8-week, 2.5 hour class, except for weeks 1 and 7 which are 
extended to 4.5-hour classes, for a total of 24 intervention hours, with weekly homework 
(amount matched to MBRT), and gentle movement exercises. The content focuses on 
psychological, physiological, and dietary effects of stress, time management techniques, fitness, 
sleep hygiene, nutrition, and factors mitigating effects of stress. Dr. Hoge (SME developer) will 
provide input and support to ensure interventionists are trained to fidelity. Training will be 
conducted by trainers approved by Dr. Hoge, with experience conducting SME and training 
interventionists. MPI Christopher, a licensed clinical psychologist with experience facilitating 
stress management groups, will oversee SME training with support from Dr. Hoge. Potential 

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adverse effects include: minor aches or strains from mindful movement practices, and mild 
emotional distress completing self-report measures or exposure to the socially evaluative cold 
pressor task challenge procedures.  
MBRT and SME groups will be led by separate interventionists, with at least masters level 
training in mental health or a related field, and matched for level of education and experience. 
MBRT interventionists will have previous training in and experience with MBRT or related 
interventions (e.g., MBSR, MBCT or MBRP), and will undergo intensive training, weekly 
clinical supervision, and regular meetings with MPIs to discuss fidelity and other clinical issues. 
Drs. Christopher, Bowen, and Witkiewitz are clinical psychologists with combined knowledge of 
psychoeducational protocols, MBIs, first responder populations, trauma, substance abuse, and 
other psychosocial outcomes. They each have extensive experience developing, implementing, 
supervising, and assessing similar interventions.  
Given the importance of internal validity of interventions in RCT research, careful attention will 
be given to intervention adherence and consistency across sites, with all sessions audio recorded. 
Under supervision of Drs. Christopher, Bowen, Witkiewitz and consultant Hoge, advanced 
graduate students at both sites will review four randomly selected audio-recorded sessions from 
each MBRT and SME cohort, adapting the MBRP Adherence and Competence measure used in 
previous trials. Drs. Christopher, Bowen and Witkiewitz will provide weekly supervision to all 
interventionists to ensure fidelity and minimize drift. 
Participants randomized to the NCI condition will not receive any intervention, but will 
participate in the same assessments as the two active intervention conditions (i.e., at baseline, 
post-intervention, 3- and 6-month follow-up). Assessment times will be yoked to those of the 
two active intervention conditions. 
5.2 Handling of Study Interventions  
Both the MBRT and SME interventions will follow a session-by-session protocol. They will both 
be delivered in 8-weekly sessions with a total training time of 24 hours.  Both groups include 
psychoeducation, gentle movement exercises, and weekly homework assignments.  
5.3 Concomitant Interventions  
5.3.1 Allowed Interventions 
Any prescribed medications are allowed during the course of the study.  
 
5.3.2 Required Interventions 
There are no required additional interventions. 
 
5.3.3 Prohibited Interventions 
There are no prohibited interventions in this study. 
5.4 Adherence Assessment  
Participant adherence to intervention will be measured by attendance (completer  6 out of 8 

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sessions1, 2), and 50% completion of assigned audio recorded home practice, tracked using 
iMINDr software. 
6. STUDY PROCEDURES  
 
 
 
6.1 
Schedule of Evaluations 
 
Assessment 
Phone 
Screen 
In Person 
Screen 
Baseline, 
Enrollment
, 
Randomiza
tion: Visit 
1 
Post-
interventio
n: Visit 2 
3 Month 
Follow-Up: 
Visit 3 
6 Month 
Follow-Up: 
Visit 4 
Verbal Consent 
X 
 
 
 
 
 
Inclusion/Exclusio
n Criteria 
X 
X 
 
 
 
 
Written Informed 
Consent  
 
X 
 
 
 
 
Alcohol Misuse 
 
X 
X 
X 
X 
X 
Depression 
 
X 
X 
X 
X 
X 
Suicidal Ideation 
 
X 
X 
X 
X 
X 
Trauma Symptoms 
 
X 
X 
X 
X 
X 
Medication Use 
 
 
X 
X 
X 
X 
Current 
Psychological 
Treatment 
 
 
X 
X 
X 
X 
Tobacco Use 
 
 
X 
X 
X 
X 
Adverse Childhood 
Experiences 
 
 
X 
 
 
 
Blood Pressure 
 
 
X 
X 
X 
 
Heart Rate  
 
 
X 
X 
X 
 
Respiration Rate 
 
 
X 
X 
X 
 
Salivary Alpha 
Amylase 
 
 
X 
 X 
X 
 
Salivary Cortisol  
 
 
X 
X 
X 
 
State Distress 
 
 
X 
X 
X 
 

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Assessment 
Phone 
Screen 
In Person 
Screen 
Baseline, 
Enrollment
, 
Randomiza
tion: Visit 
1 
Post-
interventio
n: Visit 2 
3 Month 
Follow-Up: 
Visit 3 
6 Month 
Follow-Up: 
Visit 4 
Aggression  
 
 
X 
X 
X 
X 
Psychological 
Resilience 
 
 
X 
X 
X 
X 
Sleep Disturbance 
 
 
X 
X 
X 
X 
Mindfulness 
 
 
X 
X 
X 
X 
Self-Compassion 
 
 
X 
X 
X 
X 
Burnout 
 
 
X 
X 
X 
X 
Sustained Attention 
to Response Task 
 
 
X 
X 
X 
X 
Interoceptive 
Awareness 
 
 
X 
X 
X 
X 
Perceived Stress 
 
 
X 
X 
X 
X 
Treatment 
Expectancy/Credibi
lity (MBRT and 
SME) 
 
 
X 
 
 
 
Global Impression 
of Change (MBRT 
and SME) 
 
 
 
X 
 
 
Acceptability 
(procedures) 
 
 
 
X 
 
 
Acceptability 
(MBRT and SME) 
 
 
 
X 
 
 
Compliance 
(MBRT and SME) 
 
 
 
X 
 
 

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6.2 Description of Evaluations  
 
6.2.1 Screening Evaluation   
Consenting Procedure 
There will be two consenting processes: one prior to screening (telephone administered by 
Research Assistant or Project Coordinator), and one prior to study enrollment (administered in 
person by Research Assistant or Project Coordinator). Study staff administering consent will 
have minimum bachelors level education, and will have completed the human subjects protection 
trainings. They will be trained and supervised by Drs. Bowen, Christopher, or Witkiewitz. 
Interested individuals will call PU or UNM research offices and be read a form asking them to 
provide verbal consent to complete a phone eligibility screen, which will request contact, 
employment, and demographic information.  
 
For those eligible, Research Assistants will obtain written informed consent from all participants 
prior to baseline data collection. The consent form will include information about randomization, 
release of information (including data from PPB and APD databases), researchers’ 
responsibilities regarding records collected, DHHS certificate of confidentiality, registration with 
clinicaltrials.gov, and permission to audio-record sessions. The signing of this form indicates the 
study enrollment date.  
 
All signed informed consent forms will be stored in a locking file cabinet within study 
coordinator Taylor’s locked research office (PU) or Co-I Witkiewitz’s (UNM) locked research 
lab. Members of the research team will complete a form documenting the informed consent 
process, which will be stored electronically on the secure REDCap system.   
 
Screening Procedure 
Prior to beginning the phone eligibility screen, administered by a Research Assistant or the 
Project Coordinator, participants will be informed of the study purpose, procedures, and the 
randomization process and eligibility criteria. They will provide verbal consent for a phone 
screening where they will be asked non-sensitive questions (age, employment status, previous 
mindfulness training and willingness to be randomized and attend study visits and trainings) and 
told the eligibility criteria to help determine if it is appropriate to schedule a screening visit. If 
they are likely eligible and interested, they will be invited to come to the PU-HRC or UNM 
research offices for a screening visit to complete the informed consent and screen for eligibility.  
 
Eligible participants must: 1) be 21-65 years old (age limitations for both police departments); 2) 
demonstrate English fluency; 3) be a sworn LEO at the rank of Sergeant or below; 4) agree to 
random assignment to condition; and 5) be willing to complete assessments at multiple time 
points and attend intervention groups. Individuals will be excluded from participation if they: 1) 
have participated in MBSR, MBRT or a similar mindfulness course, or 2) score in the severe 
range on brief screening measures of depression,81 suicidal ideation,82 alcohol use,83 or PTSD.84 
• Depression: Patient Health Questionnaire (PHQ-9; Score 20 or more = Severe) 

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• Suicidal Ideation:  Concise Health Risk Tracking (CHRT; Agree or Strongly Agree on 
one or more “active suicidal ideation or plans” items #10, #11 and/or #12)  
• Alcohol Use: Alcohol Use Disorders Identification Test (AUDIT; Score of 20 or more 
indicate high risk or almost certain dependence.)  
• PTSD: The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5; Score of 5 or more) 
Immediately following the in-person screening visit, participants will be informed whether they 
are eligible for study participation. Those not meeting criteria or not interested will be offered a 
list of mental health and stress management community resources. Eligible and consenting 
individuals will immediately complete the individual baseline assessments. 
We estimate screening will take approximately 20 minutes, based on experience with similar 
procedures. Research staff will enter de-identified screening data into a spreadsheet, which will 
be stored on a secure server.   
6.2.2 Enrollment, Baseline, and/or Randomization 
Enrollment  
Consent for study enrollment: 
The study enrollment date is the day an individual who has met all the screening criteria signs 
the second informed consent form. A Randomization and Enrollment Form, documenting 
enrollment and allowable window between the enrollment date and randomization, will be 
entered into REDCap, a secure internet-based survey and data management software system 
housed on a secure server. 
Randomization, immediately following baseline assessment, must occur within 60 days of 
screening.  
Baseline Assessments 
• Adverse Childhood Events 
o Childhood Trauma Questionnaire85 
• Treatment Expectancy and Credibility 
o Expectancy/Credibility Questionnaire86 
• Heart Rate, Respiration Rate, and Blood Pressure 
o Omron HEM-907XL 
o Caretaker4 cNIBP 
• Salivary Alpha Amylase* 
o SalivaBio oral swab  
• Salivary Cortisol* 
o SalivaBio oral swab  
• State Distress** 
o Visual Analogue Scale87  

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o Primary Appraisal Secondary Appraisal88 
• Psychological Resilience 
o Brief Resilience Scale89 
• Alcohol Misuse 
o PROMIS Alcohol Use90 
o PROMIS Alcohol Use Negative Consequences90 
• Depression 
o PROMIS Depression91 
• Sleep Disturbance 
o PROMIS Sleep Disturbance137 
• Mindfulness 
o Five Facet Mindfulness Questionnaire – Short Form138 
• Self-Compassion 
o Self-Compassion Scale – Short Form139 
• Aggression 
o Buss Perry Aggression Questionnaire – Short Form140 
• Suicidal Ideation 
o Concise Health Risk Tracking - Self-Report82 
• Trauma Symptoms  
o PTSD Checklist for DSM592 
• Burnout   
o Oldenburg Burnout Inventory93 
• Sustained Attention to Response Task134 
• Interoceptive Awareness  
o Multidimensional Assessment of Interoceptive Awareness-II135 
• Perceived Stress  
o Perceived Stress Scale-10136 
* To determine salivary alpha amylase (sAA) and cortisol stress reactivity and recovery, saliva 
samples will be collected 5 minutes before, immediately after, and 15, 25, 35, and 45 minutes after 
the SECPT using the SalivaBio swab method (Salimetrics, State College, PA). For each sample, 

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participants will be asked to place the swab under their tongue on the floor of their mouth for 90 
seconds. 
**The state distress evaluations will take place during a socially evaluated cold-pressor task (SECPT). 
The SECPT is a validated standardized protocol for experimental stress induction in humans. As part 
of the task, participants will be informed that they will be videotaped and that these video recordings 
will be analyzed for facial expression. Participants will then be asked to insert their right hand up to 
and including the wrist into ice water (2º C). It will be made clear that the procedure can be 
uncomfortable and that participants can remove their hand from the ice-cold water at their own 
discretion without consequences. Participants who keep their hand in the water for 3 minutes will be 
instructed at that point to remove their hand. After the SECPT, all participants will watch a neutral 
60-minute video (Planet Earth II or Blue Planet II) during the recovery period.  
Randomization 
Immediately following baseline assessment, study staff not involved in data collection will 
randomly assign participants to condition using SPSS and REDCap. The study statistician will 
create an allocation table using SPSS, and upload it to REDCap, which will be used to 
implement the randomization procedure at each site. All trial randomization codes will be stored 
within REDCap, which is a secure (HIPAA-complaint) internet-based survey and data 
management software system housed on a secure server at Oregon Health and Science 
University. 
Participants will then be notified of group assignment by a study team member. Participants 
assigned to MBRT and SME conditions will receive information regarding course structure, 
dates/times, and class format, and provided information on assessment timeline, reminder calls 
they will receive, and contact information for the research team. Initiation of study intervention 
will be between 1 and 21 days. Participants assigned to SME or NIC will be offered an 
opportunity to attend an MBRT course after the final 12-month follow-up collection of 
departmental excessive use of force data. Participants in all conditions will have access to 
resources provided by PPB or APD, including counseling services.  
 
6.2.3 Blinding 
Throughout the study, all assessors will be blind to study condition. Interventionists and 
participants will not be blinded. No one will be authorized to break that blind, and at no point in 
the study will assessors be unblinded.  
6.2.4 Followup Visits 
Postcourse followup (must occur within 21 days of end of 8-week intervention period): 
• 
Heart Rate, Respiration Rate, and Blood Pressure 
o 
Caretaker4 cNIBP 
o 
Omron HEM-907XL 
• 
Salivary Alpha Amylase 
o 
SalivaBio oral swab  
• Salivary Cortisol 

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o SalivaBio oral swab  
• 
State Distress 
o 
Visual Analogue Scale 
o Primary Appraisal Secondary Appraisal 
• 
Psychological Resilience 
o Brief Resilience Scale 
• 
Alcohol Misuse 
o PROMIS Alcohol Use 
o PROMIS Alcohol Use Negative Consequences 
• 
Depression 
o 
PROMIS Depression 
• Sleep Disturbance 
o PROMIS Sleep Disturbance 
• Mindfulness 
o Five Facet Mindfulness Questionnaire – Short Form 
• Self-Compassion 
o Self-Compassion Scale – Short Form 
• Aggression 
o Buss Perry Aggression Questionnaire – Short Form  
• 
Suicidal Ideation 
o 
Concise Health Risk Tracking - Self-Report  
• 
Trauma Symptoms  
o 
PTSD Checklist for DSM-5 
• 
Burnout   
o 
Oldenburg Burnout Inventory 
• 
Sustained Attention to Response Task  
• 
Interoceptive Awareness  
o Multidimensional Assessment of Interoceptive Awareness-II 
• Perceived Stress  
o Perceived Stress Scale-10 
• Global Impression of Change141 
• 
Acceptability  

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o 
Acceptability of Assessment Procedures 
o 
Postcourse Satisfaction Survey (MBRT and SME) 
 
• 
Intervention Compliance 
o 
Meditation Practice Questionnaire (MBRT) 
o 
iMINDr95 (MBRT and SME) 
 
3- and 6-month follow-up (must occur within ±10 days of target date. Target date is relative to 
end of the intervention period, i.e., 90 days for 3-month followup, and 180 days for 6-month 
followup): 
Note: 6-month follow-up is final study visit. 
• 
Heart Rate, Respiration Rate, and Blood Pressure (3 month only) 
o 
Caretaker4 cNIBP 
o 
Omron HEM-907XL 
• 
Salivary Alpha Amylase (3 month only) 
o 
SalivaBio oral swab  
• Salivary Cortisol (3 month only) 
o SalivaBio oral swab  
• 
State Distress (3 month only) 
o Visual Analogue Scale 
o Primary Appraisal Secondary Appraisal 
• Psychological Resilience 
o Brief Resilience Scale 
• Alcohol Misuse 
o PROMIS Alcohol Use 
o PROMIS Alcohol Use Negative Consequences 
• Depression 
o PROMIS Depression 
• Sleep Disturbance 
o PROMIS Sleep Disturbance 
• Mindfulness 
o Five Facet Mindfulness Questionnaire – Short Form 
• Self-Compassion 
o Self-Compassion Scale – Short Form 
• Aggression 

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o Buss Perry Aggression Questionnaire – Short Form  
• Suicidal Ideation 
o 
Concise Health Risk Tracking - Self-Report  
• Trauma Symptoms  
o PTSD Checklist for DSM-5 
• Burnout   
o Oldenburg Burnout Inventory 
• Sustained Attention to Response Task  
• Interoceptive Awareness  
o Multidimensional Assessment of Interoceptive Awareness-II 
• Perceived Stress  
o Perceived Stress Scale-10 
• Intervention Compliance 
o Meditation Practice Questionnaire (MBRT) 
o iMINDr95 (MBRT and SME) 
 
12-month Followup (must occur on target date, which is 360 days from the end of the 
intervention period): 
• Excessive Use of Force (Individual-level LEO excessive use of force (i.e., aggressive 
drawing and discharge of weapons, vehicle rams, illegal takedowns, administrative and 
citizen complaints) 
o BlueTeam96 Database 
 
6.2.5 Completion/Final Evaluation 
The final evaluation is the 6-month followup. See above for assessments. 
Study coordinator will contact any participants who discontinue the intervention to identify 
reason for early termination (e.g., illness, not finding the intervention beneficial, schedule 
change). In the event a participant discontinues due to an intervention-related adverse event, 
study staff will continue to follow-up with the participant until the issue is resolved.   
7. SAFETY ASSESSMENTS  
Minimal risks will exist for all participants involved in this project. Participants will be informed 
that MBRT and SME are considered to have very low risk for adverse events. These risks are 
considered to be minimal and are addressed in the consent forms.  
In this study, the expected minimal risks to the subject are as follows: 
• Minor aches or strains from mindful movement practices. 
• Mild emotional distress completing self-report measures or exposure to the video stress 

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challenge procedures.  
 
To minimize risk during the mindful movement practices, participants will be instructed to 
recognize their physical limitations and to not exceed them. Given that this is an able-bodied 
population, and movement practices are very mild (e.g., gentle stretching) it is unlikely that 
injury will occur. To minimize risk related to completing the measures or procedures, 
participants will be notified during consent that participation is voluntary and that they can 
withdraw at any time.  
7.1 Specification of Safety Parameters 
At screening, individuals will be excluded from participation if they score in the severe range on 
brief screening measures of depression, suicidal ideation, alcohol use, or PTSD. Therefore, 
potential participants with severe mental illness and related safety issues will be excluded from 
the study and will be offered a list of mental health and stress management community resources.  
7.2 Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
The interventions in this study are low risk.97, 98 Therefore we do not anticipate intervention-related 
risk to participant safety.  In addition to screening, suicidal ideation will also be assessed at 
baseline, post-intervention, 3- and 6-month follow-up. Dr. Christopher (Portland) or Dr. 
Witkiewitz (Albuquerque) will contact any participant who endorses suicide risk as evidenced 
by Concise Health Risk Tracking (CHRT) endorsement of suicidal ideation (i.e., Agree or 
Strongly Agree on one or more “active suicidal ideation or plans” items #10, #11 and/or #12). 
Drs. Christopher or Witkiewitz will gather more information and make an appropriate referral 
for mental health services.   
7.3 Adverse Events and Serious Adverse Events  
An adverse event (AE) is defined as any unfavorable and unintended diagnosis, symptom, sign 
(including an abnormal laboratory finding), syndrome or disease which either occurs during the 
study, having been absent at baseline, or if present at baseline, appears to worsen. Adverse 
events are to be recording regardless of their relationship to the study intervention.   
 
A serious adverse event (SAE) is defined as any untoward medical occurrence that results in 
death, is life threatening, requires inpatient hospitalization or prolongation of existing 
hospitalization, results in persistent or significant disability/incapacity, or is a congenital 
anomaly. 
Dr. Christopher (Portland) or Dr. Witkiewitz (Albuquerque) will contact any participant who 
endorses suicide risk as evidenced by Concise Health Risk Tracking (CHRT) endorsement of 
suicidal ideation (i.e., Agree or Strongly Agree on one or more “active suicidal ideation or 
plans” items #10, #11 and/or #12). Drs. Christopher or Witkiewitz will gather more information 
and make an appropriate referral for mental health services.   
 

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Research staff will be trained to identify potential for risk and adverse events. All student 
research assistants will be advanced doctoral students in clinical psychology, both of the MPIs 
(Christopher and Bowen) and Co-I (Witkiewitz) are licensed clinical psychologists. Thus, the 
research team has an attunement to potential adverse events that will be augmented with training 
and preparation. Together, the training team will focus on preparing all team members to 
identify potential risks for adverse events and what steps to take if such risk occurs. Collection 
of AE’s and SAE’s will be unsolicited. If an AE of SAE occurs, trained study staff will adhere 
to the Report Procedures outlined in section 7.4. 
7.4 Reporting Procedures 
All AEs will be documented using the Adverse Event Form and stored in REDCap. Drs. 
Christopher (Portland) and Witkiewitz (Albuquerque) will be responsible for completing Adverse 
Event Forms. AEs will be classified by severity level and relatedness to the study. Minimally, 
the MPI’s will be contacted in the event of any AE. The MPI’s will review the list of AEs with 
the Independent Monitoring Committee (IMC) on a semi-annual basis. SAEs that are 
unanticipated, serious, and possibly related to the study intervention will be reported to the IMC, 
IRB, and NCCIH in accordance with requirements. 
 
• Unexpected fatal or life-threatening SAEs related to the intervention will be reported to 
the NCCIH Program Officer within 72 hours. Other serious and unexpected SAEs related 
to the intervention will be reported to the NCCIH Program Official within 15 days. 
• Anticipated or unrelated SAEs will be handled in a less urgent manner but will be 
reported to the IMC, IRB, NCCIH, and other oversight organizations in accordance with 
their requirements. In the annual AE summary, the IMC Report will state that they have 
reviewed all AE reports. 
7.5 Followup for Adverse Events 
AEs will be tracked by Drs. Christopher (Portland) and Witkiewitz (Albuquerque) until resolved 
or stable. The Adverse Event Forms will be used to document actions taken and outcomes of all 
AEs.  
7.6 Safety Monitoring  
Per the NICCIH Program Official (Dr. Lanay Mudd), this study will be monitored by an 
Independent Monitoring Committee. IMC details are in section 9.4 (Interim Analyses and 
Stopping Rules) 
8. INTERVENTION DISCONTINUATION  
If a participant endorses suicidal ideation at any visit, they will be referred for psychological 
treatment and evaluated by Drs. Christopher (Portland) or Witkiewitz (Albuquerque) using the 
CHRT for suitability to continue in the study. 

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9. STATISTICAL CONSIDERATIONS  
9.1 General Design Issues  
Our analytic aim is to obtain information to estimate group means, variability, and confidence 
intervals, identify primary and secondary outcomes, and conduct an a priori power calculation 
for sample size estimation for a future fully-powered efficacy RCT. Our study aims to optimize 
measurement by empirically assessing the sensitivity and responsiveness of conceptually well-
justified candidate measures for the future trial. Since this is not an efficacy study, no primary or 
secondary hypotheses have been proposed to test the impact of MBRT on outcomes; however, 
results from this study will be used to determine primary and secondary outcome categories for 
the future trial. 
All of the self-report measures in this study have been validated and found to be reliable in past 
research. The physiological measures in this study have been validated and found to be reliable 
methods of assessing relevant biomarkers in past research. The behavioral measure that will be 
used in this study is a standardized tracking system that integrates officer, administrator, and 
citizen data and is considered the current “gold standard” for assessing LEO use of force.99-101 
An important objective of this study is to demonstrate the potential utility of this behavioral 
measure as a research outcome. Preliminary review of these data suggest there is sufficient 
variability in departments at both study sites; however, to our knowledge, the sensitivity to 
between-group differences and responsiveness to changes during an intervention have not yet 
been assessed. 
Our design is an individually-randomized group treatment trial with three arms (MBRT, SME, 
and NIC). This design was chosen in order to assess the sensitivity of outcome measures to 
between-group differences at the end of MBRT and responsiveness to changes in individual 
LEOs during the course of MBRT. Inclusion of three arms will document the willingness of 
LEOs to accept randomization to these treatment options, and enable our study staff to assess and 
optimize the implementation of all study procedures across a no-treatment control group, an 
active control group, and a treatment group at multiple study sites. This information will allow us 
to identify primary and secondary outcomes as well as detect and correct any procedural flaws in 
order to optimize procedures for a future fully-powered, multi-centered efficacy RCT.       
  
9.2 Sample Size and Randomization 
Our sample size estimate is derived from a recent conceptual framework and systematic analysis 
for conducting a feasibility trial in preparation for a future fully-powered efficacy RCT,102 as 
well as best practices103-105 and suggestions for extending CONSORT guidelines to feasibility 
trials.106 Sample sizes of 12-25 participants per arm are recommended to optimize estimation of 
group means and variability without oversampling in terms of diminishing returns in parameter 
estimation,107, 108 and to provide reasonably precise information in terms of confidence intervals 
around retention rates.109 This range is consistent with the median treatment arm size of 18 found 
in a systematic review of feasibility trials,110 and is sufficient to assess our primary goals of 
optimizing study procedures and obtaining data for parameter estimation, measure sensitivity, 
and measure responsiveness. Given the optimization aim of our study, we did not conduct an a 
priori power analysis based on effect sizes and a variance inflation factor to estimate the needed 
sample size. Our study will provide estimates of means and variability (including intraclass 

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correlations) that we will use for an a priori power calculation for sample size estimation in a 
future fully-powered efficacy RCT. Consistent with guidelines on the NIH Research Methods 
Resources Webpage, the proposal for the future fully-powered efficacy RCT will include a 
sensitivity analysis that reflects the impact of potential differences between the estimate and 
realized value of the intraclass correlation, the number of clusters per arm, and size and 
variability of those clusters, based on the data we obtain in this study. 
Measure sensitivity to our study arms will be assessed by examining relative efficiency; more 
specifically, by dividing the F-value for each behavioral, physiological, and self-report outcome 
by the largest F-value among the outcomes.111, 112 To generate the F-values for relative efficiency 
comparisons, we will conduct a one-way between-subjects Analysis of Variance for each 
outcome for MBRT vs. SME and MBRT vs. NIC. To adjust for non-ignorable clustering in order 
to obtain more accurate (i.e., unbiased) F-values, we will include study site, gender, and 
interventionist as covariates in all ANOVA analyses (i.e., perform a one-way between-subjects 
Analysis of Covariance for each outcome). Assessing relative efficiency entails generating F-
values for comparison purposes and does not require determining whether the group differences 
are significant; however, adjusting for non-ignorable clustering will allow us to avoid deviation 
from a type I error rate of .05 and calculate F-values that most precisely reflect group differences 
for each outcome. Responsiveness to change will be assessed, in part, by comparing standardized 
mean responses, which will not require conducting an inferential test and therefore will not be 
impacted by type I or type II error rates. To assess responsiveness to change, we will also 
calculate partial correlations with a global impression of change measure and residualized 
change scores for each self-reported outcome,113 adjusting for variability due to gender, study 
site, and interventionist. Just as for our relative efficiency assessment, examination of partial 
correlations will not entail significance testing, but instead generating correlation coefficients for 
comparative purposes; however, we will partial out variability due to gender, study site, and 
interventionist to obtain precise (i.e., unbiased) estimates of covariance between a global 
impression of change measure and self-report outcomes. 
Based on our recent R21 study (R21AT008854), in which we had an overall attrition rate of 20% 
across all study arms, we predict an overall attrition rate of 20% across our three study arms. 
When a participant drops out, we will attempt to obtain information from that LEO regarding the 
reason for withdrawal. This information will allow us to determine the nature of the missing data 
(i.e., missing completely at random, missing at random, missing not at random) for analytic 
purposes; assess whether the withdrawal is due to a protocol violation and if the LEO 
experienced an AE due to the intervention (if the LEO is in the MBRT or SME arm); and obtain 
information that could inform future program modifications (e.g., increase the flexibility of 
program delivery, reduce participant burden, etc.). All protocol violations will be handled by 
having the Co-PIs meet with relevant study staff to identify the nature of the violation, the reason 
for the violation, and potential remediations; the Co-PIs will then work with all relevant study 
staff to implement a remediation plan and decide on a timeframe for re-assessing the procedure 
to ensure the violation is not re-occurring.  
9.2.1 Treatment Assignment Procedures 
Randomization will be stratified first by study site, and then within study site by gender. We will 
employ a permuted-block randomization procedure, stratifying by gender, to assign participants 
to study arms. We will employ this randomization procedure to: 1) be able to optimize the study 

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procedures we plan to use in a future fully-powered efficacy RCT, 2) obtain parameter estimates 
that reflect the causal impact of MBRT on outcomes, 3) assess measure sensitivity and 
responsiveness in a way that reflects the causal impact of MBRT on participants, and 4) ensure 
balance within strata and across study arms.       
Using procedures piloted in our R21 (R21AT008854), following baseline assessment, study staff 
not involved in data collection will randomly assign participants to condition using SPSS and 
REDCap. The study statistician will create an allocation table using SPSS, and upload it to 
REDCap, which will be used to implement the randomization procedure at each site. All trial 
randomization codes will be stored within REDCap, which is a secure (HIPAA-complaint) 
internet-based survey and data management software system housed on a secure server at 
Oregon Health and Science University.  
This study does not meet criteria for a double- or triple-blinded RCT, as the study participants 
will be aware of their intervention assignment. To limit possible bias, the participants will be 
asked to not reveal their treatment assignment to data collection staff. Masking will be 
maintained by compartmentalizing study staff to a certain category of tasks that will prevent the 
study staff analyzing data from interacting with study participants and knowing participant 
names or any other personally identifying information, the study staff involved in implementing 
the intervention from being involved in data collection and analysis, the study staff involved in 
randomizing study participants and informing them of their study arm assignment from being 
involved in intervention implementation and data collection, and the study staff involved in data 
collection from knowing study arm assignment. Only study staff involved in recruitment 
activities will have access to both participant names and unique ID codes. The study statistician 
will monitor protocol fidelity around masking by maintaining contact with study staff involved 
in intervention implementation, data collection, and randomization to ensure that masking is 
maintained and identify any protocol violations. If a protocol violation occurs around masking, 
the study statistician will consult with the MPIs to identify the nature of the violation, the reason 
for the violation, and potential remediation plans. The study statistician will then implement the 
remediation plan by working with relevant study staff. Our study protocol does not require 
unblinding at any point during the study phase; however, if an unforeseen situation requires that 
unblinding becomes necessary, the study statistician, in consultation with the MPIs, would 
coordinate and implement the unblinding. If additional study staff beyond the statistician and 
MPIs are necessary to implement the unblinding, the statistician will only enlist the help of study 
staff who are absolutely necessary to implement the unblinding. If the unblinding compromises a 
study staff’s ability to engage in his/her/their assigned task, we will replace that study staff 
member.    
9.3 Definition of Populations 
Our sensitivity and responsiveness analyses will utilize an ITT approach. If attrition occurs, the 
study statistician will review the reasons for withdrawal to determine if missing data are missing 
completely at random (MCAR), missing at random (MAR), or missing not at random (MNAR). 
If data are MCAR, then we will use a complete-case approach to estimate parameters and 
conduct sensitivity and responsiveness analyses. If missing data are MAR or MNAR, we will 
employ a multiple imputation approach to impute data before estimating parameters and 
conducting sensitivity and responsiveness analyses. We will also estimate parameters and 
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purposes. 
9.4 Interim Analyses and Stopping Rules 
Interim analyses are not included in our protocol and will not be necessary to assess our study 
aims. 
 
The study will be stopped prior to its completion if: (1) the intervention is associated with 
adverse effects that call into question the safety of the intervention; (2) difficulty in study 
recruitment or retention will significantly impact the ability to evaluate the study endpoints (in 
this case, the trial will be suspended versus stopped completely to allow assessment and 
modification of recruitment procedures); (3) any new information becomes available during the 
trial that necessitates stopping the trial; or (4) other situations occur that might warrant stopping 
the trial. MPI Christopher will include an assessment of external information that might impact 
the viability of the trial in the annual progress report to NIH and will consult with the IMC to 
assess the impact of significant data loss due to problems in recruitment, retention, or data 
collection.    
The IMC members are Dr. Scott Mist, Dr. Art Blume, and Dr. Seema Clifasefi. Dr. Mist is a 
biostatistician, Drs. Blume and Clifasefi are clinical psychologists with combined experience 
with clinical trials, mindfulness-based interventions, and adaptations of clinical protocols for 
underserved and high stress populations. The IMC is composed to ensure that the safety of study 
subjects is protected while the scientific goals of the study are being met.  
 
The IMC members will not be associated with this research project, are not part of the key 
personnel involved in this grant, and have not collaborated with the two MPIs, Drs. Christopher 
and Bowen, within the past 3 years. Written documentation attesting to absence of conflict of 
interest will be collected at least annually, and each time there is a change in site investigators 
and/or institutions involved in the study. Thus, the IMC will be able to work independently of 
the MPIs. The members of the IMC will be qualified to review the patient safety data 
generated by this study. 
 
The IMC will serve in accordance with the guidelines set forth in a charter provided to each 
member. IMC members will review and agree to the charter at the initial meeting. If changes to 
the charter are necessary, the IMC will review and affirm their agreement with the changes. 
Their concurrence will be noted in the IMC meeting summary. The IMC will typically meet 
twice a year, or as deemed necessary. A quorum of more than half of the IMC members is 
required to convene a meeting of the IMC. The IMC will approve the final protocol of the 
study before the study begins enrolling participants. In monitoring the data and safety 
throughout the trial, the IMC may recommend continuation of the trial, modifications to the 
trial, or termination of the trial in the event of overwhelmingly significant efficacy difference 
between groups or unacceptable adverse events. 
 
Study progress and safety will be reviewed monthly (and more frequently if needed). Progress 
reports, including participant recruitment, retention/attrition, and AEs will be provided to the 
IMC members following each of the quarterly reviews. An Annual Report will be compiled 
and will include a list and summary of AEs. In addition, the Annual Report will address: (1) 

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whether AE rates are consistent with pre-study assumptions; (2) reason for dropouts from the 
study; (3) whether all participants met entry criteria; (4) whether continuation of the study is 
justified on the basis that additional data are needed to accomplish the stated aims of the study; 
and (5) conditions whereby the study might be terminated prematurely. The Annual Report 
will be sent to the IMC and will be forwarded to the IRB and NCCIH. The IRB and other 
applicable recipients will review progress of this study on an annual basis. 
 
The study team will generate annual Study Reports for the IMC and will provide information 
on the following study parameters: recruitment, retention, enrollment by month, 
demographics, subject status, treatment duration, and AE status. Study Report tables will be 
generated only from aggregate (not by group assignment) baseline and aggregate safety data 
for the study population. A separate Closed Safety Report, with unmasked group baseline and 
safety data, will be generated for the IMC by a designated unmasked member of the team, but 
will not be reviewed by the study team. As noted above, we will also review quarterly with the 
IMC subject accrual, subject status, adherence data, AEs and SAEs. 
 
During the funding of this study, any action by the IRB or one of the study investigators that 
results in a temporary or permanent suspension of the study will be reported to the NCCIH 
Program Official within one business day of notification. 
9.5 Outcomes  
Outcomes will be analyzed using quantitative analyses (sensitivity and responsiveness) after 
creating composite scores for self-report measures and calculating mean responses across time or 
area of the curve for physiological outcomes. For behavioral data, we will analyze individual 
behavioral items as well as a composite score. 
 
Committee oversight of outcome analyses and results is not included in our protocol (oversight 
of AE information is discussed above in section 9.4). However, Drs. Christopher (Portland) and 
Witkiewitz (Albuquerque) will review all data collection forms on an ongoing basis for data 
completeness and accuracy as well as protocol compliance. The primary source of research 
materials will be a combination of self-report (i.e., psychological resilience, trauma, alcohol 
misuse, depression, suicidality, burnout, and aggression), physiological (HR, BP, sAA, cortisol), 
and behavioral (use of force reports in the BlueTeam database) outcomes. Self-report measures 
will be collected via Qualtrics; psychophysiological data will be collected via saliva, HR, RR, and 
BP; and audio homework assignment data will be collected via iMINDr; and study forms will be 
entered by the research team and stored electronically on REDCap. Behavioral data will be 
obtained from the database with the assistance of police department staff. Drs. Christopher 
(Portland) and Witkiewitz (Albuquerque) will oversee data downloads from Qualtrics, REDCap, 
and iMINDr as well as psychophysiological and behavioral data collection; a second research 
team member will verify that data downloads and collection were done correctly. The project 
manager will manage data storage.  
 
9.5.1 Primary Outcome   
Given that our goal is to optimize study procedures and outcome measurement through 
sensitivity and responsiveness analyses, we will not be grouping outcome measures into primary 

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and secondary categories. The data we obtain through this trial will be used to identify primary 
and secondary outcomes for a future fully-powered efficacy RCT. 
9.5.2 Secondary Outcomes   
Given that our goal is to optimize study procedures and outcome measurement through 
sensitivity and responsiveness analyses, we will not be grouping outcome measures into primary 
and secondary categories. The data we obtain through this trial will be used to identify primary 
and secondary outcomes for a future fully-powered efficacy RCT. 
9.6 Data Analyses  
Quantitative:  
Following best practice guidelines114-116 including CONSORT feasibility guidelines106 and past 
research,111, 117 we will measure sensitivity (using a relative efficiency approach) and 
responsiveness to change (examining within-group change over time). Relative efficiency 
analyses will be used to establish that our outcome measures are sensitive to differences between 
our treatment arm of focus (MBRT) and our other two arms - an active control arm (SME) and a 
no-treatment control arm (NIC). Therefore, sensitivity analyses will focus on assessing the 
degree to which outcomes are sensitive to study arms and not whether change is significant. 
Sensitivity to differences for MBRT compared to SME and NIC will be assessed by examining 
the relative efficiency of each outcome variable for MBRT versus SME and NIC separately. We 
will calculate the relative efficiency for MBRT versus SME by conducting one-way, between-
subjects Analysis of Covariance (ANCOVA) analyses with MBRT versus SME as the 
independent variable and each outcome variable at post-training as the dependent variable; we 
will include study site and gender as covariates. We will also conduct ANOVAs using the same 
independent and dependent variables to ensure that all inferential tests are conducted and identify 
any potential Type II Errors among the ANCOVAs. We will then divide the F-statistic for each 
behavioral (BlueTeam use of force; individual indicators of use of force as well as a composite 
score of use of force using the individual indicators), physiological (HR, BP, sAA, and cortisol), 
and self-report (aggression, alcohol misuse, depression, suicidal ideation, trauma symptoms, 
burnout, and psychological resilience) outcome by the largest F-statistic among these analyses, 
such that the larger the number, the more sensitive that outcome is to the impact of MBRT 
relative to the active control group.112  
To calculate the relative efficiency of MBRT versus NIC, we will conduct one-way, between-
subject ANCOVAs with MBRT vs. NIC as the independent variable, each outcome variable at 
post-training as the dependent variable, and gender and study site as covariates. Again, we will 
also conduct ANOVAs using the same independent and dependent variables to ensure all 
inferential tests are conducted and identify any potential Type II Errors among the ANCOVAs. 
We will then divide the F-statistic for each behavioral, physiological, and self-report outcome by 
the largest F-statistic among these analyses; again, the larger the number, the more sensitive the 
outcome is to MBRT relative to the no-treatment control group. These sensitivity analyses will 
allow assessment of which behavioral, physiological, and self-report outcomes are most sensitive 
to MBRT. When examining sAA and cortisol, AUCi will be used as the dependent variable.  
To optimize measurement of stress reactivity, we will assess HR and BP during the three phases 
(baseline, reactivity, and recovery) of the stress induction task as separate dependent variables. 
Lastly, we will examine the speed of return to baseline during the recovery phase of the stress 

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induction task for sAA, cortisol, HR, and BP as additional dependent variables.118-120 
Responsiveness to change across time will be assessed in the MBRT arm for behavioral, 
physiological, and self-report outcomes by: 1) calculating and comparing standardized mean 
responses (SMR) for outcomes by subtracting the baseline mean response for each outcome from 
the post-intervention mean response for that outcome, and dividing by the standard deviation of 
change for that outcome;121, 122 2) calculating and comparing partial correlation coefficients 
(adjusting for study site and gender) between a global impression of change measure that 
captures the subjective experience of changes in stress, job performance, and resilience at post-
intervention and residualized change scores (baseline to post-intervention) for each self-report 
outcome.123-125 For both SMR values and correlation coefficients, the higher the absolute value, 
the more responsive the outcome is to change across time in the MBRT arm. We will conduct 
additional correlation analyses using the same variables without adjusting for study site and 
gender to identify any potential Type II Errors among the partial correlations. 
In addition, we will examine data for any indications of systematic site differences. Using 
baseline data (where sample size will be greatest) and pooling arms, since no treatment 
differences are expected at baseline, distributions of standardized responses on outcome 
measures will be summarized, graphed, and compared across sites. Key parameters, reliability 
estimates (i.e., Cronbach’s alpha), and intraclass correlations will be estimated and checked for 
discrepancies between sites. Identified discrepancies will be investigated to determine site-
specific issues that would undermine assumptions of conceptual and structural equivalence of 
measurement. 
Given the optimization aim of our study, our analyses will not adjust for intraclass correlations 
across study arms (and any heterogeneity in those correlations). Our study will allow us to obtain 
information about the magnitude of intraclass correlations and the degree to which they are 
heterogenous across study arms, which we will use for our data analysis plan in a future fully-
powered efficacy RCT. 
 
Qualitative:  
In the proposed study, focus groups will be conducted following post-intervention assessment to 
qualitatively assess participants’ experience of all procedures. Using an approximate 2:1:1 ratio, 
a random sample of 15, 8, and 7 MBRT, SME, and NIC participants, respectively, will be invited 
to participate in 2 MBRT, 1 SME, and 1 NIC focus groups at each site, for a total of 8 focus 
groups. Each participant will attend only one focus group. We anticipate approximately 11 
MBRT, 6 SME, and 5 NIC participants will agree to attend, for an anticipated total focus group 
sample of 44 (22 MBRT, 12 SME, 10 NIC) across sites. All focus groups will be conducted 
within two-weeks of the end of the intervention period to maximize internal consistency. It is 
anticipated that each focus group will last approximately 60-90 minutes. 
 
MPIs Bowen and Christopher have developed draft questions for the focus group guide. 
Consistent with the timeline submitted in the proposal, the study team will finalize the focus 
group guide and protocol by month 4 of study year 1. Per recently published guidelines for 
maximizing impact of qualitative research in feasibility studies to inform an RCT,126 broad focus 
group question categories include: 1) intervention content and delivery; 2) trial design, conduct, 
and process; 3) treatment outcomes; and 4) measures and assessment burden. Sample questions 
include: 
 
 

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Intervention Content and Delivery (MBRT and SME groups) 
• If you invited a friend to participate in the training, what would you tell them?   
• What aspects of the training were most helpful for you?  
• What aspects of the training were less helpful for you?  
• What were the biggest obstacles to fully engaging in or completing the training? 
 
Trial Design, Conduct, and Process (all groups) 
• What was your reaction to being randomized to the ________ group? 
• Were reminder calls/contact with coordinator helpful (too much/ too little)? 
• What feedback do you have to help improve the experience of future officers who will 
take part in the same study? 
 
Outcomes (MBRT and SME groups) 
• What changes, if any, did you notice in your resilience after completing the training? 
• Did the training affect your ability to cope with stress? 
• Has the training impacted your day-to-day work? 
 
Measures and Assessment Burden (all groups) 
• What was your experience of coming to the lab for testing? 
• What was your experience with the computerized measures (i.e., assessment burden, 
clarity of questions, ease of administration process)? 
• What was your experience with the saliva collection (i.e., burden, clarity of instructions)? 
Focus group discussions will be conducted using standardized methods, as described by Krueger 
and Casey127. Each group will be co-led by a trained moderator and an assistant, and will be 
audio recorded and transcribed. The moderator will introduce the study and guide discussion, 
and the assistant will handle logistics, note preliminary themes, and assist in summarizing the 
discussion, sharing the summary with participants at the end of the group (Krueger & Casey)127. 
LEOs will be instructed to refrain from disclosing unnecessary personal information. Informed 
consent procedures will clearly state that participation in focus groups is voluntary, and 
participants will be instructed to share only what they choose to. They will be reminded that all 
content will be de-identified to protect their anonymity.  
 
A thematic analysis approach128-130 will be used to explore participant experiences with the goal 
of understanding feasibility, acceptability and impact of the assessments, protocol, and 
intervention. Analyses will consist of: 1) familiarization, 2) initial coding, 3) creating themes, 4) 
reviewing themes, 5) defining and naming themes, and 6) data interpretation. MPI Christopher 
and two trained research team members will initially independently review focus group data. 
Emerging themes will be used to develop a coding scheme and the team will then independently 
apply the codes from the finalized code structure. The coding team will meet regularly to review 
coding and resolve differences by in-depth discussion and negotiated consensus to ensure inter-
rater reliability. A dynamic approach will be used by analyzing the first wave of focus group data 
following initial MBRT and SME groups, which may result in changes to intervention or trial 
procedures, then reassessing the impact of these changes on participants’ experience of 
assessments, protocol, and/or intervention.131, 132 We will also assess the equivalence of 
experience across sites, and confirm self-report measurement sensitivity based on the 

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relationship between qualitative reports of change and quantitative results on outcome 
measures.133  
 
10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms  
Trained graduate research assistants will collect participant data. Assessors will be blinded to 
condition. Self-report data will be collected using Qualtrics, a data collection software platform 
that operates on a secure server. Psychophysiological equipment will be used to assess heart rate, 
respiration rate, and blood pressure (Caretaker4 cNIBP). The SalivaBio oral swab method will be 
used to collect saliva. Each participant will be identified by a unique ID code and data will be 
linked to unique ID. Personal identifying information (i.e., names and phone numbers) will only 
be used on forms such as the informed consent or telephone contact logs, where they are essential. 
Any forms with identifying information will be kept secure and separate from data. Tracking 
forms linking names and unique study ID codes will be stored on REDCap, a secure internet-
based survey and data management software system housed on a secure server, accessible only 
to IRB-authorized research staff. 
10.2 Data Management  
Data will be stored in REDCap and Qualtrics. REDCap is a secure (HIPAA-complaint) internet-
based survey and data management software system housed on a secure server at Oregon Health 
and Science University. Qualtrics is a data collection software platform supported by Pacific 
University that operates on a secure server. 
10.3 Quality Assurance  
10.3.1 Training 
Goals and Strategies: All study staff will be trained in NIH Good Clinical Practice. 
Interventionists will undergo intensive MBRT or SME training. Ongoing oversight and 
supervision of all intervention procedures will occur throughout the trial, including weekly 
review of audio-recorded MBRT and SME sessions and clinical supervision. We will hone 
intervention protocols and session coding procedures, train coders, and adapt the Adherence and 
Competence Scale77 for use with both MBRT and SME to ensure parallel domains are assessed, 
and that fidelity is equivalent, both across sites and between MBRT and SME interventions. 
Specifically, four of the eight sessions (50%) will be randomly selected from each MBRT and 
SME group to be rated by two independent coders, who will be randomly assigned to 
session. Raters will be trained until they meet ≥.75 interrater reliability, then meet for periodic 
calibration meetings to prevent rater drift. 
10.3.2 Quality Control Committee  
Our Steering Committee will oversee quality control. 
10.3.3 Metrics 
Senior study staff will visit both study sites to ensure equivalent equipment, training in lab-based 

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protocols, and access to oversight and supervision. All study staff will train in NIH Good 
Clinical Lab practices. Spot checks on saliva procedures will be performed twice monthly at both 
sites by study coordinators. Corrective feedback will be given on all procedures by MPIs and Co-
Is throughout the trial. Study coordinators at each site will spot check self-report and meditation 
practice outcomes at all time points to assess for out of range values and excessive missing data. 
10.3.4 Protocol Deviations 
The Steering Committee will meet monthly to advise MPIs on study coordination and 
management, and the IMC will meet regularly to review procedures and any deviations that 
occur. Deviations will be documented in a study log maintained by the MPI’s at Pacific and the 
site PI at UNM.  
10.3.5 Monitoring 
There will be ongoing oversight and supervision of all lab and assessment procedures throughout 
the trial, including weekly contact between study investigators, weekly site team meetings, and 
bi-weekly multi-site full staff meetings to review lab and data collection protocols. Investigators 
will review a checklist of all procedures to ensure completion and fidelity to each stage, and take 
corrective action as needed. To ensure equivalence of data management, appropriate study staff 
at both sites will be trained in: 1) iMINDr (homework adherence data); 2) Microsoft Excel (to 
which iMINDr data will be uploaded at post, 3- and 6-months); 3) NVivo (analyze qualitative 
focus group data); 4) SPSS (analyze quantitative data), 5) Qualtrics (collect and store self-report 
data); Inquisit (for Sustained Attention Response Task) and 6) REDCap (used for project 
management and completion tasks such as form completion, tracking randomization assignment, 
and attendance). Procedures for data collection, tracking, and management will be identical 
across sites. 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review  
This protocol and the informed consent document and any subsequent modifications will be 
reviewed and approved by the IRB responsible for oversight of the study.  
11.2 Informed Consent Forms 
A signed consent form will be obtained from each participant. The consent form will describe the 
purpose of the study, the procedures to be followed, and the risks and benefits of participation. A 
copy will be given to each participant and this fact will be documented in the participant’s 
record. Signed informed consent forms will be stored in a locking file cabinet within Project 
Coordinator Taylor’s (Portland) or Co-I Witkiewitz’s (Albuquerque) locked research office. 
Members of the research team will complete a form documenting the informed consent process, 
which will be stored electronically on the secure REDCap system. No special classes or 
vulnerable participants will be involved in the study. All participants are LEOs, and thus fluent 
English speakers, literate, and  ≥ 21 years of age. All participants will thus be able to complete 
informed consent. 

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11.3 Participant Confidentiality  
Any data, specimens, forms, reports, audio recordings, and other records that leave the site will 
be identified only by a participant identification number (Participant ID, PID) to maintain 
confidentiality. All study data will be stored on Box, a secure, HIPAA-compliant data storage 
system housed and supported by Pacific University and University of New Mexico. All computer 
entry and networking programs will be done using PIDs only. Information will not be released 
without written permission of the participant, except as necessary for monitoring by IRB, the 
FDA, the NCCIH, and the OHRP. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NCCIH, the OHRP, the FDA, or 
other government agencies as part of their duties to ensure that research participants are 
protected.  
12. COMMITTEES 
Steering Committee: Drs. Bowen, Christopher, Witkiewitz, and NCCIH staff. 
13. PUBLICATION OF RESEARCH FINDINGS  
Publication of the results of this trial will be governed by the policies and procedures developed 
by the Steering Committee. 
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15. SUPPLEMENTS/APPENDICES 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment 
Community/RA 
Consent 1/ 
Screening 
Phone/RA 
(180- day target date +/- 7 days) 
Consent 2/ 
Enrollment 
Lab/RA 
Baseline 
Assessment 
Lab/RA 
Randomization 
Lab/PC and RA 
Intervention 
Lab/Interventionists 
Postcourse 
Assessment 
Lab/RA 
3-Month 
Assessment 
Lab/RA 
6-month 
Assessment 
Lab/RA 
12-month 
Assessment 
BlueTeam database/RA  
Variable (participant driven) 
60-day maximum 
21-day window  
(90-day target date +/- 10) 
15. 1  Procedures Schedule 
21-day maximum 
Same day 
21-day maximum 
21-day window  
(90-day target date +/- 10)