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

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ClinicalTrials.gov Identifier: NCT03784846
Recruitment Status : Not yet recruiting
First Posted : December 24, 2018
Last Update Posted : July 18, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Michael Christopher, PhD, Pacific University

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.

Condition or disease Intervention/treatment Phase
Stress, Psychological Aggression Behavioral: Mindfulness-Based Resilience Training Behavioral: Stress Management Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Individually-Randomized Group Treatment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mindfulness-Based Resilience Training for Aggression, Health, and Stress Among Law Enforcement Officers
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Arm Intervention/treatment
Experimental: Mindfulness-Based Resilience Training
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.
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.

Active Comparator: 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.
Behavioral: 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.

No Intervention: No Intervention Control
No contact control condition (other than baseline, post, and follow-up assessments)



Primary Outcome Measures :
  1. Change in on the Job Behavioral Use of Force [ Time Frame: baseline, 12 month followup ]
    BlueTeam database of individual-level LEO excessive use of force (i.e., aggressive drawing and discharge of weapons, vehicle rams, illegal takedowns, administrative and citizen complaints)

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


Secondary Outcome Measures :
  1. Change in Physiological Stress Reactivity and Recovery [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup ]
    salivary cortisol (nmol/L)

  2. Change in Physiological Stress Reactivity and Recovery [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup ]
    salivary alpha amylase (sAA) (nmol/L)

  3. Change in Physiological Stress Reactivity and Recovery [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup ]
    heart rate

  4. Change in Physiological Stress Reactivity and Recovery [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup ]
    respiration rate

  5. Change in Physiological Stress Reactivity and Recovery [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup ]
    blood pressure (systolic and diastolic)

  6. Change in Psychological Resilience [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup ]
    Brief Resilience Scale. Scores range from 1-5, with higher scores indicating greater resilience.

  7. Change in Alcohol Use [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup ]
    Patient Reported Outcome Measurement System (PROMIS) Alcohol Use. Scores range from 39-77, with higher scores indicating greater alcohol use.

  8. Change in Alcohol Use Negative Consequences [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup ]
    Patient Reported Outcome Measurement System (PROMIS) Alcohol Use Negative Consequences.Scores range from 39-77, with higher scores indicating greater alcohol use negative consequences.

  9. Change in Depression [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup ]
    Patient Reported Outcome Measurement System (PROMIS) Depression. Scores range from 38-80, with higher scores indicating more depression.

  10. Change in Suicidal Thinking [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup ]
    Concise Heath Risk Tracking Scale-Self-Report. Scores range from 7-35, with higher scores indicating greater suicidal ideation.

  11. Change in Trauma Symptoms [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup ]
    PTSD Checklist for DSM-5. Scores ranges from 0-80, with higher scores indicating greater PTSD symptoms.

  12. Change in Burnout [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup ]
    Oldenburg Burnout Inventory. Scores range from 1-4, with higher scores indicating greater burnout.

  13. State Distress [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup ]
    Visual Analogue Scale. Rating of level of distress: stressful, painful, unpleasant during stress challenge and recovery. Scores are rated on a 0-10 scale, with greater scores indicating higher distress.

  14. State Distress [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup ]
    Primary Appraisal Secondary Appraisal. Evaluation of anticipated amount of challenge and estimation of the available coping strategies. Scores range from 10-70, with higher scores indicating greater distress.

  15. Change in Sustained Attention [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup ]
    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.

  16. Change in Perceived Stress [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup ]
    Perceived Stress Scale-10. Scores range from 0-40, with higher scores indicating greater perceived stress.

  17. Change in Sleep Disturbance [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup ]
    Patient Reported Outcome Measurement System (PROMIS) Sleep Disturbance. Scores range from 32-76, with higher scores indicating greater sleep disturbance.

  18. Change in Self-Compassion [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup ]
    Self-Compassion Scale-Short Form. Scores range from 12-60, with higher scores indicating greater self-compassion.

  19. Change in Mindfulness [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup ]
    Five Facet Mindfulness Questionnaire-Short Form. Each FFMQ-SF facet has five items (except for non-reactivity, which has 4 items) resulting in a 24-item scale. Each facet ranges from 5-25 (4-20 for non-reactivity), higher scores indicate greater mindfulness.

  20. Change in Interoceptive Awareness [ Time Frame: baseline, post-intervention (8 weeks), 3 month followup, 6 month followup ]
    Multidimensional Assessment of Interoceptive Awareness-II. Scores range from 0-185, with higher scores indicating greater interoceptive awareness.

  21. Treatment Acceptability [ Time Frame: post-intervention (8 weeks) ]
    Postcourse satisfaction survey. Scores range from 0-24, with higher scores indicating greater treatment acceptability.

  22. Treatment Compliance [ Time Frame: post-intervention (8 weeks) ]
    iMINDr app. Objective assessment of type, frequency and duration of homework practice.

  23. Assessment Acceptability [ Time Frame: post-intervention (8 weeks) ]
    Acceptability of self-report questionnaires. Four item measure of acceptability of assessment procedures.

  24. Treatment Expectancy and Credibility [ Time Frame: baseline ]
    Expectancy/Credibility Questionnaire. Scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies

  25. Global Impression of Change [ Time Frame: post-intervention (8 weeks) ]
    Clinical Global Impressions Scale. Single-item, 7-point measure of perceived change in functioning as a result of the intervention.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784846


Contacts
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Contact: Michael Christopher, PhD 503-352-2498 mchristopher@pacificu.edu

Locations
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United States, New Mexico
University of New Mexico Not yet recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Katie Witkiewitz, PhD    505-925-2334    katiew@unm.edu   
Principal Investigator: Katie Witkiewitz, PhD         
United States, Oregon
Pacific University Not yet recruiting
Forest Grove, Oregon, United States, 97116
Contact: Michael Christopher, Ph.D.    503-352-2498    mchristopher@pacificu.edu   
Contact: Sarah Bowen, Ph.D.    503-352-3000    bowen@pacificu.edu   
Principal Investigator: Michael Christopher, PhD         
Principal Investigator: Sarah Bowen, PhD         
Sponsors and Collaborators
Pacific University
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)

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Responsible Party: Michael Christopher, PhD, Multiple Principal Investigator, Pacific University
ClinicalTrials.gov Identifier: NCT03784846     History of Changes
Other Study ID Numbers: PacificU
U01AT009841 ( U.S. NIH Grant/Contract )
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aggression
Stress, Psychological
Behavioral Symptoms