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Resilience Training for First Responders in the Opioid Epidemic

Primary Purpose

Compassion Fatigue, Burnout, Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Resilience Training
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Compassion Fatigue focused on measuring First Responders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Current employment as a first responder
  • West Virginia residency
  • Availability/willingness to engage in a 2.5-day retreat style intervention on identified dates.

Exclusion Criteria:

  • Not an actively employed first responder
  • Does not currently reside in WV
  • Not willing or able to participate

Sites / Locations

  • Kanawha-Charleston Health Department
  • Saint John XXIII Pastoral Center
  • Marshall University
  • West Virginia University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness-Based Resilience Training

Arm Description

Designed to train participants in a number of experiential exercises evoking qualities of mindfulness: mental focus, sustained attention and personal and situational awareness. These exercises include versions of the body scan (body awareness exercise), sitting meditation, mindful movement, walking meditation, eating meditation, mindful martial arts exercises and other elements of mindfulness.

Outcomes

Primary Outcome Measures

Change in Mindfulness (FFMQ)
The Five Facet Mindfulness Questionnaire (FFMQ). It examines 5 key domains of mindfulness: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Scores range from 39 to 195, with higher scores indicating greater tendency to be mindful.
Change in Mindfulness (MPQ)
The Mindfulness Process Questionnaire (MPQ) is an 8-item self-report measure that assesses the degree to which mindfulness is intentionally practiced or attempted and the ability to bring compassionate awareness to the present moment after observing the attention has drifted off or become judgmental. Items are scored on a 5-point Likert type scale ranging from "not at all characteristic of me" to "entirely characteristic of me," and total scores range from 8 to 40, with higher scores indicating greater engagement in mindfulness practices and skills.
Change in Occupational Stress (PSQ)
The Police Stress Questionnaire (PSQ) (organizational [OPSQ] and operational [OPS] subscales) is a 40-item questionnaire consisting of 2 subscales measuring operational stressors (20 job content items) and organizational stressors (20 job context items) on a 7-point Likert-type scale, ranging from 1 (no stress at all) to 7 (a lot of stress) and resulting in a maximum score of 140; higher scores indicate greater stress.
Change in Occupational Stress (PSS)
The Perceived Stress Scale-4 (PSS) is a 4-item scale used to assess perceived stress in life situations. Responses are on a 5-point Likert-type scale ranging from "never" to "very often;" higher scores indicate greater perceived stress, with a maximum score of 16.
Change in Emotional Intelligence
The Emotional Intelligence Scale (EIS) is a 33-item scale of emotional intelligence. Items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), and 3 items are reverse scored, producing a score range from 33 to 165. All items are summed to create a total score, and higher scores indicate greater emotional intelligence.
Change in Emotional Regulation
The Difficulties in Emotional Regulation Scale (DERS) is a 36-item measure that assesses clinically relevant difficulties in emotion regulation. Items range from 1 ("almost never") to 5 ("almost always), and the total score ranges from 36 to 180. Higher scores indicate greater difficulties with emotion regulation.
Change in Resilience
The Brief Resilience Scale (BRS) is a 6-item scale designed to assess the ability to recover from stress using a 5-point Likert scale, ranging from 1 ("strongly disagree") to 5 (strongly agree). Scores are summed, then divided by the total number of items, to produce a total score ranging from 1 to 5. Higher scores indicate greater resilience.
Change in Family Functioning
The General Family Functioning Subscale (GFF) consists of 12 items partly comprising the Family Assessment Device (FAD), a 60-item measure utilizing a 4-point Likert-type scale. Altogether, the FAD consists of 6 subscales; however, the GFF incorporates items from the 6 subscales and is commonly used an indicator of global family functioning. Higher scores on the GFF indicate more problematic family functioning, with a maximum score of 48.
Change in Sleep
Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Sleep. Item is rated on a 5-point Likert type scale with higher scores indicating greater symptom severity.
Change in Anger
Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Anger. Item is rated on a 5-point Likert type scale with higher scores indicating greater symptom severity.
Change in Health
Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Health. Item is rated on a 5-point Likert type scale with higher scores indicating greater symptom severity.
Change in Fatigue
Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Fatigue . Item is rated on a 5-point Likert type scale with higher scores indicating greater symptom severity.

Secondary Outcome Measures

Full Information

First Posted
June 2, 2021
Last Updated
June 16, 2021
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT04929613
Brief Title
Resilience Training for First Responders in the Opioid Epidemic
Official Title
Intensive Mindfulness-based Resilience Training in First Responders: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 24, 2017 (Actual)
Primary Completion Date
June 26, 2018 (Actual)
Study Completion Date
June 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
First responders (law enforcement, firefighters, and emergency medical system personnel) are subjected to daily pressures from their duties with resultant compassion fatigue, burnout, anger, poor mental and physical health, maladaptive behavior, and sleep disturbance. The unprecedented heroin and opioid epidemic in West Virginia has accelerated the stresses as these first responders witness overdoses and overdose death on a frequent basis. The plight and suffering of children of the overdose victims is an additional overlooked element in the stress on the first responder community. The proposed project will deliver mindfulness-based resilience training to improve the mental and physical wellbeing, prevent compassion fatigue, burnout, and attrition of first responders and performance improvement by reducing predictable cognitive errors in the Charleston and Huntington areas and measure the effects of this training on this population using validated questionnaires and salivary cortisol before and after the training.
Detailed Description
West Virginia (WV) is in the midst of an unprecedented opioid and heroin epidemic with profound social, health, and economic consequences. This stress, especially among law enforcement officials (LEOs), is often experienced within a context of excessive anger, which decreases wellbeing and has the potential to negatively impact public wellbeing as well. These public safety personnel are often left to manage stress and anger in a cultural context that does not support help-seeking behavior and that encourages maladaptive coping mechanisms. Mindfulness-Based Resilience Training (MBRT) has demonstrated significant improvement in self-reported mindfulness, resilience, perceived operational and administrative stress, burnout, emotional intelligence, emotion regulation, mental and physical health, anger, fatigue, and sleep disturbance Introducing effective evidence-based training to first responders has the potential to improve well-being and decrease burnout and improve the performance of the people who protect the community. Should this hypotheses be confirmed, first responders in West Virginia will have an effective intervention to improve resilience, address perceived stress and burnout, and lead to greater mental and physical wellbeing in the face of unprecedented stresses associated with the opioid and heroin epidemic. This would enable this intervention to be scaled across the state among other populations of first responders in this unprecedented public health crisis. First responders will be recruited from volunteers targeting leadership and thought leaders at the frontline from the three-county area, but primarily from the cities of Charleston and Huntington, to participate in one of two 2.5-day intensive MBRT training sessions. Each 2.5-day session will be coordinated with each agency to ensure maximum participation without disrupting work schedules. Up to 35 participants will participate in each cohort. This study aims to recruit 2 cohorts from the pool of first responders in the Cabell, Kanawha, and Putnam Counties area for a minimum of 50 participants and maximum of 70 participants. Self report measures will be conducted at time 0 (before the intervention), time 1 (after the 2.5-day intensive training), time 2 (4 weeks after the 2.5-day intensive training and after the week 4 remote/virtual booster training) and at time 3 (90 days after the initial intensive training).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compassion Fatigue, Burnout, Stress, Mindfulness
Keywords
First Responders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Resilience Training
Arm Type
Experimental
Arm Description
Designed to train participants in a number of experiential exercises evoking qualities of mindfulness: mental focus, sustained attention and personal and situational awareness. These exercises include versions of the body scan (body awareness exercise), sitting meditation, mindful movement, walking meditation, eating meditation, mindful martial arts exercises and other elements of mindfulness.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Resilience Training
Intervention Description
2.5-day intensive MBRT training sessions.
Primary Outcome Measure Information:
Title
Change in Mindfulness (FFMQ)
Description
The Five Facet Mindfulness Questionnaire (FFMQ). It examines 5 key domains of mindfulness: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Scores range from 39 to 195, with higher scores indicating greater tendency to be mindful.
Time Frame
Up to 90 days
Title
Change in Mindfulness (MPQ)
Description
The Mindfulness Process Questionnaire (MPQ) is an 8-item self-report measure that assesses the degree to which mindfulness is intentionally practiced or attempted and the ability to bring compassionate awareness to the present moment after observing the attention has drifted off or become judgmental. Items are scored on a 5-point Likert type scale ranging from "not at all characteristic of me" to "entirely characteristic of me," and total scores range from 8 to 40, with higher scores indicating greater engagement in mindfulness practices and skills.
Time Frame
Up to 90 days
Title
Change in Occupational Stress (PSQ)
Description
The Police Stress Questionnaire (PSQ) (organizational [OPSQ] and operational [OPS] subscales) is a 40-item questionnaire consisting of 2 subscales measuring operational stressors (20 job content items) and organizational stressors (20 job context items) on a 7-point Likert-type scale, ranging from 1 (no stress at all) to 7 (a lot of stress) and resulting in a maximum score of 140; higher scores indicate greater stress.
Time Frame
Up to 90 days
Title
Change in Occupational Stress (PSS)
Description
The Perceived Stress Scale-4 (PSS) is a 4-item scale used to assess perceived stress in life situations. Responses are on a 5-point Likert-type scale ranging from "never" to "very often;" higher scores indicate greater perceived stress, with a maximum score of 16.
Time Frame
Up to 90 days
Title
Change in Emotional Intelligence
Description
The Emotional Intelligence Scale (EIS) is a 33-item scale of emotional intelligence. Items are rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree), and 3 items are reverse scored, producing a score range from 33 to 165. All items are summed to create a total score, and higher scores indicate greater emotional intelligence.
Time Frame
Up to 90 days
Title
Change in Emotional Regulation
Description
The Difficulties in Emotional Regulation Scale (DERS) is a 36-item measure that assesses clinically relevant difficulties in emotion regulation. Items range from 1 ("almost never") to 5 ("almost always), and the total score ranges from 36 to 180. Higher scores indicate greater difficulties with emotion regulation.
Time Frame
Up to 90 days
Title
Change in Resilience
Description
The Brief Resilience Scale (BRS) is a 6-item scale designed to assess the ability to recover from stress using a 5-point Likert scale, ranging from 1 ("strongly disagree") to 5 (strongly agree). Scores are summed, then divided by the total number of items, to produce a total score ranging from 1 to 5. Higher scores indicate greater resilience.
Time Frame
Up to 90 days
Title
Change in Family Functioning
Description
The General Family Functioning Subscale (GFF) consists of 12 items partly comprising the Family Assessment Device (FAD), a 60-item measure utilizing a 4-point Likert-type scale. Altogether, the FAD consists of 6 subscales; however, the GFF incorporates items from the 6 subscales and is commonly used an indicator of global family functioning. Higher scores on the GFF indicate more problematic family functioning, with a maximum score of 48.
Time Frame
Up to 90 days
Title
Change in Sleep
Description
Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Sleep. Item is rated on a 5-point Likert type scale with higher scores indicating greater symptom severity.
Time Frame
Up to 90 days
Title
Change in Anger
Description
Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Anger. Item is rated on a 5-point Likert type scale with higher scores indicating greater symptom severity.
Time Frame
Up to 90 days
Title
Change in Health
Description
Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Health. Item is rated on a 5-point Likert type scale with higher scores indicating greater symptom severity.
Time Frame
Up to 90 days
Title
Change in Fatigue
Description
Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Fatigue . Item is rated on a 5-point Likert type scale with higher scores indicating greater symptom severity.
Time Frame
Up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Current employment as a first responder West Virginia residency Availability/willingness to engage in a 2.5-day retreat style intervention on identified dates. Exclusion Criteria: Not an actively employed first responder Does not currently reside in WV Not willing or able to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith Zullig, PhD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanawha-Charleston Health Department
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
Facility Name
Saint John XXIII Pastoral Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25314
Country
United States
Facility Name
Marshall University
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25755
Country
United States
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26508
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Resilience Training for First Responders in the Opioid Epidemic

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