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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03784846
Other study ID # 1295787-14
Secondary ID U01AT009841
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date June 30, 2022

Study information

Verified date June 2023
Source Pacific University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 109
Est. completion date June 30, 2022
Est. primary completion date May 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness-Based Resilience Training
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 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.

Locations

Country Name City State
United States University of New Mexico Albuquerque New Mexico
United States Pacific University Forest Grove Oregon

Sponsors (3)

Lead Sponsor Collaborator
Pacific University National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Aggression Buss-Perry Aggression Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater aggression. baseline, post-intervention (week 8), 3-month followup, 6-month followup
Secondary Change in C-reactive Protein Blood spot analysis of high-sensitivity C-reactive protein. baseline, post-intervention (8 weeks), 3 month followup
Secondary Change in Interleukin-6 Blood spot analysis of interleukin-6. baseline, post-intervention (8 weeks), 3 month followup
Secondary Change in Interleukin-10 Blood spot analysis of interleukin-10. baseline, post-intervention (8 weeks), 3 month followup
Secondary Change in Tumor Necrosis Factor-alpha Blood spot analysis of tumor necrosis factor-alpha. baseline, post-intervention (8 weeks), 3 month followup
Secondary Change in Psychological Resilience Brief Resilience Scale. Scores range from 1-5, with higher scores indicating greater resilience. baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Secondary Change in Alcohol Use Patient Reported Outcome Measurement System (PROMIS) Alcohol Use. Scores range from 39-77, with higher scores indicating greater alcohol use. baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Secondary 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. baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Secondary Change in Depression Patient Reported Outcome Measurement System (PROMIS) Depression. Scores range from 38-80, with higher scores indicating more depression. baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Secondary Change in Suicidal Thinking Concise Heath Risk Tracking Scale-Self-Report. Scores range from 7-35, with higher scores indicating greater suicidal ideation. baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Secondary Change in Trauma Symptoms PTSD Checklist for DSM-5. Scores ranges from 0-80, with higher scores indicating greater PTSD symptoms. baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Secondary Change in Burnout Oldenburg Burnout Inventory. Scores range from 1-4, with higher scores indicating greater burnout. baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Secondary 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. baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Secondary Change in Perceived Stress Perceived Stress Scale-10. Scores range from 0-40, with higher scores indicating greater perceived stress. baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Secondary Change in Sleep Disturbance Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance. Scores range from 32-76, with higher scores indicating greater sleep disturbance. baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Secondary Change in Self-Compassion Self-Compassion Scale-Short Form. Scores range from 1-5, with higher scores indicating greater self-compassion. baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Secondary Change in Mindfulness Five Facet Mindfulness Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater mindfulness. baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Secondary Change in Interoceptive Awareness Multidimensional Assessment of Interoceptive Awareness-II. Scores range from 1-6, with higher scores indicating greater interoceptive awareness. baseline, post-intervention (8 weeks), 3 month followup, 6 month followup
Secondary 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. post-intervention (8 weeks)
Secondary Treatment Compliance Objective assessment of duration of homework practice. Measure only administered to Mindfulness-Based Resilience Training and Stress Management Education arms. post-intervention (8 weeks)
Secondary 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. baseline
Secondary 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. post-intervention (8 weeks)
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