Feasibility and Acceptability of Mindfulness-based Resilience Training for Rural Law Enforcement Officers

July 31, 2023 updated by: Pacific University

Feasibility and Acceptability of Mindfulness-based Resilience Training for Problematic Alcohol Use, Mental Health, and Aggression in Rural Law Enforcement Officers

Rural law enforcement officers (LEOs) are exposed to unique and significant stressors, yet have access to fewer resources, compared to urban counterparts, to mitigate harmful effects of stress. This elevates risk for maladaptive coping strategies such as problematic alcohol use, mental health consequences, and aggression and excessive use of force. The proposed supplement will assess feasibility and accessibility of Mindfulness-Based Resilience Training (MBRT), with added intervention components addressing alcohol use, in under-resourced rural LEOs to ensure success in a future multisite efficacy trial assessing effects of MBRT on mental health and behavioral outcomes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The stress inherent to policing affects both officer health as well as the safety of their respective communities. The investigators current and previous research has shown that Mindfulness-Based Resilience Training (MBRT) leads to improvement in law enforcement officer (LEO) mental health and behavioral outcomes, including alcohol use and aggression. In the investigators current multisite R01 feasibility trial of MBRT, they have successfully met key feasibility and acceptability benchmarks in urban and suburban LEO samples. What is lacking is exploration of feasibility and acceptability in rural LEOs, who face unique stressors and challenges, and an integration of evidence-based preventive intervention components to directly target problematic alcohol use. Individuals living in rural communities are recognized as a target population for health disparities research. Rural LEOs experience stressors specific to rural populations such as isolation and work-role overload, yet often have fewer resources, including less access to stress management trainings and mental health care, compared to their urban and suburban counterparts. The combination of high stress coupled with low resources supporting mental health and performance may lead to increased reliance on maladaptive behaviors, such as excessive alcohol use. Indeed, LEOs have disproportionately higher rates of alcohol use, not only affecting their own health and wellbeing but also exacerbating effects of stress on aggression and excessive force in critical incidents. Preliminary evidence suggests alcohol use may be more problematic among rural, relative to urban, LEOs. The proposed supplement would support collection of data on feasibility and acceptability of MBRT in under-resourced rural LEOs to inform further adaptations to better serve this community. Additionally, the investigators propose to integrate specific elements of an evidence-based mindfulness intervention for substance use disorders to explicitly address problematic alcohol use and associated consequences among rural LEOs, enhancing effects of MBRT on officer health, and in turn reducing aggression and excessive use of force in critical incidents. Completion of supplement aims will strengthen support for a multisite trial of an intervention that holds great potential to reduce aggression and increase health and wellbeing among urban, suburban and rural LEOs and the communities they serve.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Oregon
      • Forest Grove, Oregon, United States, 97116
        • Recruiting
        • Pacific University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Christopher, PhD
        • Principal Investigator:
          • Sarah Bowen, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • be 21-65 years old,
  • demonstrate English fluency,
  • be a sworn, full-time, active status law enforcement officer, and
  • be willing to complete assessments at multiple time points and attend intervention groups

Exclusion Criteria:

  • previous participation in mindfulness-based stress reduction (MBSR), MBRT or a similar mindfulness course,
  • endorse suicidal ideation, or
  • unable or unwilling to give written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindfulness-Based Resilience Training (MBRT)
MBRT is an 2.5-day 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)
MBRT is designed to enhance resilience in the presence of acute and chronic LEO stressors. MBRT will be delivered in a hybrid format. An intensive, 22-hour in-person training will be offered, followed by 4 weekly 90-minute zoom classes. The in-person portion of the training will span 3 days: 4 hours day 1, 6 hours day 2, and 6 hours day 3. MBRT contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions. MBRT is designed to address stressors inherent to police work, including critical incidents, job dissatisfaction, public scrutiny, and interpersonal, affective and behavioral challenges.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Aggression
Time Frame: baseline, post-intervention (4 weeks), 3 month followup
Buss-Perry Aggression Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater aggression.
baseline, post-intervention (4 weeks), 3 month followup
Change in Alcohol Use Negative Consequences
Time Frame: baseline, post-intervention (4 weeks), 3 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.
baseline, post-intervention (4 weeks), 3 month followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pacific University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Christopher, Pacific University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 090-18
  • 3R01AT009841-04S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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