NCT04929613

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 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

Study Start

First participant enrolled

October 24, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

January 30, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

8 months

First QC Date

June 2, 2021

Results QC Date

July 21, 2021

Last Update Submit

January 26, 2024

Conditions

Keywords

First Responders

Outcome Measures

Primary Outcomes (52)

  • Five Factor Mindfulness Questionnaire (FFMQ)

    The Five Factor 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.

    Baseline

  • Five Factor Mindfulness Questionnaire (FFMQ)

    The Five Factor 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.

    Immediately following intervention

  • Five Factor Mindfulness Questionnaire (FFMQ)

    The Five Factor 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.

    30 days post intervention

  • Five Factor Mindfulness Questionnaire (FFMQ)

    The Five Factor 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.

    90 days post intervention

  • Mindfulness Process Questionnaire (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 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.

    Baseline

  • Mindfulness Process Questionnaire (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 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.

    Immediately following intervention

  • Mindfulness Process Questionnaire (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 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.

    30 days post intervention

  • Mindfulness Process Questionnaire (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 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.

    90 days post intervention

  • Organizational Police Stress Questionnaire

    The Police Stress Questionnaire (PSQ) (organizational \[OPSQ\]) 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 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.

    Baseline

  • Organizational Police Stress Questionnaire

    The Police Stress Questionnaire (PSQ) (organizational \[OPSQ\]) 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 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.

    Immediately following intervention

  • Organizational Police Stress Questionnaire

    The Police Stress Questionnaire (PSQ) (organizational \[OPSQ\]) 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 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.

    30 days post intervention

  • Organizational Police Stress Questionnaire

    The Police Stress Questionnaire (PSQ) (organizational \[OPSQ\]) 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 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.

    90 days post intervention

  • Operational Police Stress Questionnaire

    The Police Stress Questionnaire (PSQ) (Operational) 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 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.

    Baseline

  • Operational Police Stress Questionnaire

    The Police Stress Questionnaire (PSQ) (Operational) 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 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.

    Immediately following intervention

  • Operational Police Stress Questionnaire

    The Police Stress Questionnaire (PSQ) (Operational) 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 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.

    30 days post intervention

  • Operational Police Stress Questionnaire

    The Police Stress Questionnaire (PSQ) (Operational) 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 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.

    90 days post intervention

  • Perceived Stress Scale (PSS)

    The Perceived Stress Scale-4 (PSS) is a 4-item scale used to assess perceived stress in life situations. Responses are on a Likert-type scale ranging from "never" to "very often;" higher scores indicate greater perceived stress, with a minimum score of 0 and maximum score of 16.

    Baseline

  • Perceived Stress Scale (PSS)

    The Perceived Stress Scale-4 (PSS) is a 4-item scale used to assess perceived stress in life situations. Responses are on a Likert-type scale ranging from "never" to "very often;" higher scores indicate greater perceived stress, with a minimum score of 0 and maximum score of 16.

    Immediately following intervention

  • Perceived Stress Scale (PSS)

    The Perceived Stress Scale-4 (PSS) is a 4-item scale used to assess perceived stress in life situations. Responses are on a Likert-type scale ranging from "never" to "very often;" higher scores indicate greater perceived stress, with a minimum score of 0 and maximum score of 16.

    30 days post intervention

  • Perceived Stress Scale (PSS)

    The Perceived Stress Scale-4 (PSS) is a 4-item scale used to assess perceived stress in life situations. Responses are on a Likert-type scale ranging from "never" to "very often;" higher scores indicate greater perceived stress, with a minimum score of 0 and maximum score of 16.

    90 days post intervention

  • 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.

    Baseline

  • 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.

    Immediately following intervention

  • 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.

    30 days post intervention

  • 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.

    90 days post intervention

  • Emotional Intelligence Scale

    The Emotional Intelligence Scale (EIS) is a 33-item scale of emotional intelligence. Items are rated on a 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.

    Baseline

  • Emotional Intelligence Scale

    The Emotional Intelligence Scale (EIS) is a 33-item scale of emotional intelligence. Items are rated on a 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.

    Immediately following intervention

  • Emotional Intelligence Scale

    The Emotional Intelligence Scale (EIS) is a 33-item scale of emotional intelligence. Items are rated on a 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.

    30 day post intervention

  • Emotional Intelligence Scale

    The Emotional Intelligence Scale (EIS) is a 33-item scale of emotional intelligence. Items are rated on a 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.

    90 days

  • Brief Resilience Scale

    The Brief Resilience Scale (BRS) is a 6-item scale designed to assess the ability to recover from stress using a 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.

    Baseline

  • Brief Resilience Scale

    The Brief Resilience Scale (BRS) is a 6-item scale designed to assess the ability to recover from stress using a 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.

    Immediately following intervention

  • Brief Resilience Scale

    The Brief Resilience Scale (BRS) is a 6-item scale designed to assess the ability to recover from stress using a 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.

    30 days post intervention

  • Brief Resilience Scale

    The Brief Resilience Scale (BRS) is a 6-item scale designed to assess the ability to recover from stress using a 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.

    90 days post intervention

  • General Family Functioning

    The General Family Functioning Subscale (GFF) consists of 12 items. Respondents complete 12 items with a four-point response scale (1 = strongly agree, 4 = strongly disagree). A mean score is computed. Higher scores on the GFF indicate more problematic family functioning. The minimum score on the GFF is 12, and the maximum score is 48.

    Baseline

  • General Family Functioning

    The General Family Functioning Subscale (GFF) consists of 12 items. Respondents complete 12 items with a four-point response scale (1 = strongly agree, 4 = strongly disagree). A mean score is computed. Higher scores on the GFF indicate more problematic family functioning. The minimum score on the GFF is 12, and the maximum score is 48.

    Immediately following intervention

  • General Family Functioning

    The General Family Functioning Subscale (GFF) consists of 12 items. Respondents complete 12 items with a four-point response scale (1 = strongly agree, 4 = strongly disagree). A mean score is computed. Higher scores on the GFF indicate more problematic family functioning. The minimum score on the GFF is 12, and the maximum score is 48.

    30 days post intervention

  • General Family Functioning

    The General Family Functioning Subscale (GFF) consists of 12 items. Respondents complete 12 items with a four-point response scale (1 = strongly agree, 4 = strongly disagree). A mean score is computed. Higher scores on the GFF indicate more problematic family functioning. The minimum score on the GFF is 12, and the maximum score is 48.

    90 days post intervention

  • PROMIS Sleep

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Sleep. Item is rated on a Likert type scale (Score range of 4-19) with higher scores indicating greater symptom severity.

    Baseline

  • PROMIS Sleep

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Sleep. Item is rated on a Likert type scale (Score range of 4-19) with higher scores indicating greater symptom severity.

    Immediately following intervention

  • PROMIS Sleep

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Sleep. Item is rated on a Likert type scale (Score range of 4-19) with higher scores indicating greater symptom severity.

    30 days post intervention

  • PROMIS Sleep

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Sleep. Item is rated on a Likert type scale (Score range of 4-19) with higher scores indicating greater symptom severity.

    90 days post intervention

  • PROMIS Health

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Health. Item is rated on a Likert type scale (Score Range 0-40) with higher scores indicating greater symptom severity.

    Baseline

  • PROMIS Health

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Health. Item is rated on a Likert type scale (Score Range 0-40) with higher scores indicating greater symptom severity.

    Immediately following intervention

  • PROMIS Health

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Health. Item is rated on a Likert type scale (Score Range 0-40) with higher scores indicating greater symptom severity.

    30 days post intervention

  • PROMIS Health

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Health. Item is rated on a Likert type scale (Score Range 0-40) with higher scores indicating greater symptom severity.

    90 days post intervention

  • PROMIS Fatigue

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Fatigue. Item is rated on a Likert type scale (score range 4-20) with higher scores indicating greater symptom severity.

    Baseline

  • PROMIS Fatigue

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Fatigue. Item is rated on a Likert type scale (score range 4-20) with higher scores indicating greater symptom severity.

    Immediately following intervention

  • PROMIS Fatigue

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Fatigue. Item is rated on a Likert type scale (score range 4-20) with higher scores indicating greater symptom severity.

    30 days post intervention

  • PROMIS Fatigue

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Fatigue. Item is rated on a Likert type scale (score range 4-20) with higher scores indicating greater symptom severity.

    90 days post intervention

  • PROMIS Anger

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Anger. Item is rated on a Likert type scale (score range 5-25) with higher scores indicating greater symptom severity.

    Baseline

  • PROMIS Anger

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Anger. Item is rated on a Likert type scale (score range 5-25) with higher scores indicating greater symptom severity.

    Immediately following intervention

  • PROMIS Anger

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Anger. Item is rated on a Likert type scale (score range 5-25) with higher scores indicating greater symptom severity.

    30 days post intervention

  • PROMIS Anger

    Patient Reported Outcomes Measurement Information System (PROMIS®) is comprised of Anger. Item is rated on a Likert type scale (score range 5-25) with higher scores indicating greater symptom severity.

    90 days post intervention

Study Arms (1)

Mindfulness-Based Resilience Training

EXPERIMENTAL

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.

Behavioral: Mindfulness-Based Resilience Training

Interventions

2.5-day intensive MBRT training sessions.

Mindfulness-Based Resilience Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Kanawha-Charleston Health Department

Charleston, West Virginia, 25301, United States

Location

Saint John XXIII Pastoral Center

Charleston, West Virginia, 25314, United States

Location

Marshall University

Huntington, West Virginia, 25755, United States

Location

West Virginia University

Morgantown, West Virginia, 26508, United States

Location

MeSH Terms

Conditions

Compassion FatigueBurnout, Psychological

Condition Hierarchy (Ancestors)

Mental FatigueFatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorOccupational StressStress, Psychological

Results Point of Contact

Title
Keith Zullig, PhD
Organization
West Virginia University

Study Officials

  • Keith Zullig, PhD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 18, 2021

Study Start

October 24, 2017

Primary Completion

June 26, 2018

Study Completion

June 26, 2018

Last Updated

January 30, 2024

Results First Posted

January 30, 2024

Record last verified: 2024-01

Locations