Stress, PsychologicalNCT03784846

Mindfulness-Based Resilience Training for Aggression, Health, and Stress Among Law Enforcement Officers

A study testing Mindfulness-Based Resilience Training and Stress Management Education in people with Stress, Psychological and Aggression, run by Pacific University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Stress, Psychological, Aggression
What is being tested?: Mindfulness-Based Resilience Training and Stress Management Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 109 participants
Where: 2 sitesUnited States
Study dates: 1 Oct 2019to 30 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

be 21-65 years old (age limitations for both police departments),
demonstrate English fluency,
be a sworn, full-time, active status law enforcement officer,
agree to random assignment to condition, and
be willing to complete assessments at multiple time points and attend intervention groups

Who cannot join

previous participation in MBSR, MBRT or a similar mindfulness course,
score in the severe range on brief screening measures of depression, suicidal ideation, alcohol use, or PTSD, or
unable or unwilling to give written informed consent.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of New Mexico
Albuquerque, New Mexico, 87106
Pacific University
Forest Grove, Oregon, 97116

Other trials in United States

About this study

Law enforcement officers (LEOs) are exposed to significant stressors, elevating their risk for aggression and excessive use of force, as well as mental health consequences, including post-traumatic stress disorder, burnout, alcohol misuse, depression, and suicide. The proposed study will identify, optimize and refine best clinical and research practices across two sites to ensure success in a future multisite efficacy trial assessing preventative effects of Mindfulness-Based Resilience Training on physiological, behavioral, and psychological outcomes.

Read the detailed description

Law enforcement officers (LEOs) are exposed to significant stressors, elevating their risk for aggression and excessive use of force. Such dysfunctional stress reactivity can lead to devastating consequences for their community, including unjustified shootings, severe beatings, and fatal chokings. It can also lead to serious consequences for the LEOs, including elevated incidence of post-traumatic stress disorder, burnout, alcohol misuse, depression, and suicide. A recent meta-analysis of LEO stress reduction programs found little evidence to demonstrate that such approaches are effective, highlighting the urgent need for preventive interventions targeting the stress inherent to policing. Mindfulness training is a promising approach with high-stress populations that has been shown effective in reducing stress and increasing resilience. In a recent pilot feasibility study (R21AT008854), the study team established initial feasibility, acceptability, and adherence to procedures in a single-site RCT assessing Mindfulness-Based Resilience Training (MBRT), a preventive intervention designed to improve LEO mental health and resilience, and reduce aggression and excessive use of force. The R21 data suggest physiological mechanisms and potential clinical benefit in a sample of LEOs. Relative to waitlist control, MBRT participants showed improvements in stress reactivity, aggression, burnout, occupational stress, sleep disturbance, and psychological flexibility. Implemented at two sites, the proposed study is designed to establish optimal protocols and procedures for a future full-scale, multi-site trial assessing effects of MBRT versus an attention control (Stress Management Education) and a no-intervention control, on physiological, behavioral, and psychological outcomes. To prepare for this future clinical trial, this study will: a) enhance efficiency of recruitment, engagement and retention; b) optimize lab, assessment, and data management procedures; c) optimize intervention training and ensure fidelity to intervention protocols; and d) assess participant experience and optimize outcome measures across sites. The long-term objective of this line of research is to develop an intervention that will reduce violence and increase resilience among LEOs, as well as yield significant benefits for communities and residents they serve.

Conditions: Stress, Psychological, Aggression
Being tested: Mindfulness-Based Resilience Training, Stress Management Education
Medical subject headings: Stress, Psychological, Aggression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-Based Resilience TrainingBehavioural
MBRT is an 8-week program combining training in standardized mindfulness practices targeting factors that facilitate resilience, CBT, and psychoeducation. It contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions.
Stress Management EducationBehavioural
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.

Study groups in NCT03784846
Study group	Role	What they receive
Mindfulness-Based Resilience Training	Experimental	MBRT is an 8-week program combining training in standardized mindfulness practices targeting factors that facilitate resilience, cognitive behavioral therapy (CBT), and psychoeducation. It contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions. Receives: Behavioral: Mindfulness-Based Resilience Training
Stress Management Education	Active comparator	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. Receives: Behavioral: Stress Management Education
No Intervention Control	No intervention	No contact control condition (other than baseline, post, and follow-up assessments)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Aggression
Buss-Perry Aggression Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater aggression.
Measured: baseline, post-intervention (week 8), 3-month followup, 6-month followup

Secondary outcomes (21)

Change in C-reactive Protein
Blood spot analysis of high-sensitivity C-reactive protein.
Measured: baseline, post-intervention (8 weeks), 3 month followup
Change in Interleukin-6
Blood spot analysis of interleukin-6.
Measured: baseline, post-intervention (8 weeks), 3 month followup
Change in Interleukin-10
Blood spot analysis of interleukin-10.
Measured: baseline, post-intervention (8 weeks), 3 month followup
Change in Tumor Necrosis Factor-alpha
Blood spot analysis of tumor necrosis factor-alpha.
Measured: baseline, post-intervention (8 weeks), 3 month followup
Change in Psychological Resilience
Brief Resilience Scale. Scores range from 1-5, with higher scores indicating greater resilience.
Measured: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Alcohol Use
Patient Reported Outcome Measurement System (PROMIS) Alcohol Use. Scores range from 39-77, with higher scores indicating greater alcohol use.
Measured: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Alcohol Use Negative Consequences
Patient Reported Outcome Measurement System (PROMIS) Alcohol Use Negative Consequences.Scores range from 39-77, with higher scores indicating greater alcohol use negative consequences.
Measured: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Depression
Patient Reported Outcome Measurement System (PROMIS) Depression. Scores range from 38-80, with higher scores indicating more depression.
Measured: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Suicidal Thinking
Concise Heath Risk Tracking Scale-Self-Report. Scores range from 7-35, with higher scores indicating greater suicidal ideation.
Measured: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Trauma Symptoms
PTSD Checklist for DSM-5. Scores ranges from 0-80, with higher scores indicating greater PTSD symptoms.
Measured: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Burnout
Oldenburg Burnout Inventory. Scores range from 1-4, with higher scores indicating greater burnout.
Measured: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Sustained Attention
Sustained Attention to Response Task. A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amongst a background of frequent non-targets. Increased errors indicates less sustained attention.
Measured: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Perceived Stress
Perceived Stress Scale-10. Scores range from 0-40, with higher scores indicating greater perceived stress.
Measured: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Sleep Disturbance
Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance. Scores range from 32-76, with higher scores indicating greater sleep disturbance.
Measured: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Self-Compassion
Self-Compassion Scale-Short Form. Scores range from 1-5, with higher scores indicating greater self-compassion.
Measured: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Mindfulness
Five Facet Mindfulness Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater mindfulness.
Measured: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Interoceptive Awareness
Multidimensional Assessment of Interoceptive Awareness-II. Scores range from 1-6, with higher scores indicating greater interoceptive awareness.
Measured: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Treatment Acceptability
Postcourse satisfaction survey. Scores range from 4-16, with higher scores indicating greater treatment acceptability. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.
Measured: post-intervention (8 weeks)
Treatment Compliance
Objective assessment of duration of homework practice. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.
Measured: post-intervention (8 weeks)
Treatment Expectancy and Credibility
Expectancy/Credibility Questionnaire. Scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies. Scores range from 7-21, with higher scores indicating greater expectancy and credibility.
Measured: baseline
Global Impression of Change
Clinical Global Impressions Scale. Measure of perceived change in functioning as a result of the intervention. Scores range from 3-21, with higher scores indicating a greater impression of change. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms.
Measured: post-intervention (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 201930 Jun 2022

First posted24 Dec 2018
Study start1 Oct 2019
Primary completion17 May 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Individually-Randomized Group Treatment
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03784846
Sponsor's protocol ID: 1295787-14
Other IDs: U01AT009841
Status last verified: Jun 2023
First submitted: 13 Dec 2018
Last updated: 3 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Christopher M, Bowen S, Witkiewitz K. Mindfulness-based resilience training for aggression, stress and health in law enforcement officers: study protocol for a multisite, randomized, single-blind clinical feasibility trial. Trials. 2020 Feb 28;21(1):236. doi: 10.1186/s13063-020-4165-y.
PubMed 32111233
Christopher M, Bowen S, Witkiewitz K, Grupe D, Goerling R, Hunsinger M, Oken B, Korecki T, Rosenbaum N. A multisite feasibility randomized clinical trial of mindfulness-based resilience training for aggression, stress, and health in law enforcement officers. BMC Complement Med Ther. 2024 Apr 4;24(1):142. doi: 10.1186/s12906-024-04452-y.
PubMed 38575888
Christopher M, Ferry M, Simmons A, Vasquez A, Reynolds B, Grupe D. Psychometric properties of the Buss-Perry Aggression Questionnaire-short form among law enforcement officers. Aggress Behav. 2024 Mar;50(2):e22145. doi: 10.1002/ab.22145.
PubMed 38477412

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mindfulness-Based Resilience Training for Aggression, Health, and Stress Among Law Enforcement Officers
ClinicalTrials.gov ID: NCT03784846
Acronym / sponsor ID: 1295787-14
Conditions: Stress, Psychological, Aggression
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: Pacific UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
Study start: 1 Oct 2019 (actual)
Primary completion: 17 May 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 24 Dec 2018 (actual)
Results: Posted 3 Jul 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: Individually-Randomized Group Treatment

Arm	Type	Receives
Mindfulness-Based Resilience Training	Experimental	Behavioral: Mindfulness-Based Resilience TrainingMBRT is an 8-week program combining training in standardized mindfulness practices targeting factors that facilitate resilience, cognitive behavioral therapy (CBT), and psychoeducation. It contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions.
Stress Management Education	Active comparator	Behavioral: Stress Management EducationSME was designed as an active control condition for other mindfulness-based intervention trials. SME uses a group-based didactic approach with modules on physiological and dietary effects of stress, time management, sleep physiology and insomnia, nutrition, exercise, stress hardiness, and factors mitigating impacts of stress.
No Intervention Control	No intervention	–No contact control condition (other than baseline, post, and follow-up assessments)

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

be 21-65 years old (age limitations for both police departments),
demonstrate English fluency,
be a sworn, full-time, active status law enforcement officer,
agree to random assignment to condition, and
be willing to complete assessments at multiple time points and attend intervention groups

Key exclusion criteria (3 listed)

previous participation in MBSR, MBRT or a similar mindfulness course,
score in the severe range on brief screening measures of depression, suicidal ideation, alcohol use, or PTSD, or
unable or unwilling to give written informed consent.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness-Based Resilience TrainingMBRT 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.	Behavioural	Mindfulness-Based Resilience Training
Stress Management EducationSME 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.	Behavioural	Stress Management Education

Primary outcome

Change in Aggression
Time frame: baseline, post-intervention (week 8), 3-month followup, 6-month followup
Buss-Perry Aggression Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater aggression.

21 secondary outcomes

Change in C-reactive Protein
Time frame: baseline, post-intervention (8 weeks), 3 month followup
Change in Interleukin-6
Time frame: baseline, post-intervention (8 weeks), 3 month followup
Change in Interleukin-10
Time frame: baseline, post-intervention (8 weeks), 3 month followup
Change in Tumor Necrosis Factor-alpha
Time frame: baseline, post-intervention (8 weeks), 3 month followup
Change in Psychological Resilience
Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Alcohol Use
Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Alcohol Use Negative Consequences
Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Depression
Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Suicidal Thinking
Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Trauma Symptoms
Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Burnout
Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Sustained Attention
Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Perceived Stress
Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Sleep Disturbance
Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Self-Compassion
Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Mindfulness
Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Change in Interoceptive Awareness
Time frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Treatment Acceptability
Time frame: post-intervention (8 weeks)
Treatment Compliance
Time frame: post-intervention (8 weeks)
Treatment Expectancy and Credibility
Time frame: baseline
Global Impression of Change
Time frame: post-intervention (8 weeks)

Results and safety

Results posted to the registry on 3 Jul 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mindfulness-Based Resilience Training (MBRT)	17	6
Stress Management Education (SME)	14	3
No Intervention Control	5	0

Primary outcome: Change in Aggression

Time frame: baseline, post-intervention (week 8), 3-month followup, 6-month followup. Mean (Standard Deviation). Unit: score on a scale

Measure	Mindfulness-Based Resilience Training (MBRT) n = 33	Stress Management Education (SME) n = 24	No Intervention Control n = 16
Baseline	1.94 (.64)	1.67 (.45)	1.85 (.79)
post-intervention (week 8)	1.72 (.48)	1.68 (.57)	1.98 (.82)
3-month followup	1.63 (.50)	1.58 (.37)	1.84 (.76)
6-month followup	1.57 (.46)	1.69 (.60)	1.78 (.66)

Population analysed: Numbers at post-intervention, 3-month followup, and 6-month followup reflect attrition or participants or lost to followup.

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse event was followed for 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindfulness-Based Resilience Training	0 of 50 (0%)	1 of 50 (2%)	0 of 50
Stress Management Education	0 of 38 (0%)	0 of 38 (0%)	0 of 38
No Intervention Control	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32111233Christopher M, Bowen S, Witkiewitz K. Mindfulness-based resilience training for aggression, stress and health in law enforcement officers: study protocol for a multisite, randomized, single-blind clinical feasibility trial. Trials. 2020 Feb 28;21(1):236. doi: 10.1186/s13063-020-4165-y.
Derived from this study: PubMed 38575888Christopher M, Bowen S, Witkiewitz K, Grupe D, Goerling R, Hunsinger M, Oken B, Korecki T, Rosenbaum N. A multisite feasibility randomized clinical trial of mindfulness-based resilience training for aggression, stress, and health in law enforcement officers. BMC Complement Med Ther. 2024 Apr 4;24(1):142. doi: 10.1186/s12906-024-04452-y.
Derived from this study: PubMed 38477412Christopher M, Ferry M, Simmons A, Vasquez A, Reynolds B, Grupe D. Psychometric properties of the Buss-Perry Aggression Questionnaire-short form among law enforcement officers. Aggress Behav. 2024 Mar;50(2):e22145. doi: 10.1002/ab.22145.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Resilience Training and Stress Management Education in people with Stress, Psychological and Aggression, run by Pacific University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Aggression (time frame: baseline, post-intervention (week 8), 3-month followup, 6-month followup). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03784846, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.