NCT03784846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 3, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

2.6 years

First QC Date

December 13, 2018

Results QC Date

May 11, 2023

Last Update Submit

June 9, 2023

Conditions

Stress, PsychologicalAggression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (21)

  • Change in C-reactive Protein

    baseline, post-intervention (8 weeks), 3 month followup

  • Change in Interleukin-6

    baseline, post-intervention (8 weeks), 3 month followup

  • Change in Interleukin-10

    baseline, post-intervention (8 weeks), 3 month followup

  • Change in Tumor Necrosis Factor-alpha

    baseline, post-intervention (8 weeks), 3 month followup

  • Change in Psychological Resilience

    baseline, post-intervention (8 weeks), 3 month followup, 6 month followup

  • +16 more secondary outcomes

Study Arms (3)

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.

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.

Behavioral: Stress Management Education

No Intervention Control

NO INTERVENTION

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

Interventions

Mindfulness-Based Resilience TrainingBEHAVIORAL

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.

Mindfulness-Based Resilience Training
Stress Management EducationBEHAVIORAL

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.

Stress Management Education

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of New Mexico

Albuquerque, New Mexico, 87106, United States

Location

Pacific University

Forest Grove, Oregon, 97116, United States

Location

Related Publications (3)

  • 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.

    PMID: 32111233RESULT

  • 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.

    PMID: 38575888DERIVED

  • 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.

    PMID: 38477412DERIVED

MeSH Terms

Conditions

Stress, PsychologicalAggression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAberrant Motor Behavior in DementiaSocial Behavior

Results Point of Contact

Title
Michael Christopher, Ph.D.
Organization
Pacific University
mchristopher@pacificu.edu
503-352-2498

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Individually-Randomized Group Treatment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Multiple Principal Investigator

Study Record Dates

First Submitted

December 13, 2018

First Posted

December 24, 2018

Study Start

October 1, 2019

Primary Completion

May 17, 2022

Study Completion

June 30, 2022

Last Updated

July 3, 2023

Results First Posted

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(2)