Clinical trial NCT03784846: Mindfulness-Based Resilience Training for Aggression, Health, and Stress Among Law Enforcement Officers
Official title: Mindfulness-Based Resilience Training for Aggression, Health, and Stress Among Law Enforcement Officers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Aggression
Lead sponsor: Pacific University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2018-12-24
Enrollment: 109
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individually-Randomized Group Treatment
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Aggression
timeFrame: baseline, post-intervention (week 8), 3-month followup, 6-month followup
Secondary outcomes:
measure: Change in C-reactive Protein
timeFrame: baseline, post-intervention (8 weeks), 3 month followup
measure: Change in Interleukin-6
timeFrame: baseline, post-intervention (8 weeks), 3 month followup
measure: Change in Interleukin-10
timeFrame: baseline, post-intervention (8 weeks), 3 month followup
measure: Change in Tumor Necrosis Factor-alpha
timeFrame: baseline, post-intervention (8 weeks), 3 month followup
measure: Change in Psychological Resilience
timeFrame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
measure: Change in Alcohol Use
timeFrame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
measure: Change in Alcohol Use Negative Consequences
timeFrame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
measure: Change in Depression
timeFrame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
measure: Change in Suicidal Thinking
timeFrame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
measure: Change in Trauma Symptoms
timeFrame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
measure: Change in Burnout
timeFrame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
measure: Change in Sustained Attention
timeFrame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
measure: Change in Perceived Stress
timeFrame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
measure: Change in Sleep Disturbance
timeFrame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
measure: Change in Self-Compassion
timeFrame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
measure: Change in Mindfulness
timeFrame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
measure: Change in Interoceptive Awareness
timeFrame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
measure: Treatment Acceptability
timeFrame: post-intervention (8 weeks)
measure: Treatment Compliance
timeFrame: post-intervention (8 weeks)
measure: Treatment Expectancy and Credibility
timeFrame: baseline
measure: Global Impression of Change
timeFrame: post-intervention (8 weeks)
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: Forest Grove
country: United States
facility: Pacific University
state: Oregon
Study officials:
References:
citation: 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.