Compassion FatigueNCT04929613
Resilience Training for First Responders in the Opioid Epidemic
A study testing Mindfulness-Based Resilience Training in people with Compassion Fatigue and Burnout, run by West Virginia University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Compassion Fatigue, Burnout, Stress
- What is being tested?
- Mindfulness-Based Resilience Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Oct 2017to 26 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current employment as a first responder
- West Virginia residency
- Availability/willingness to engage in a 2.5-day retreat style intervention on identified dates.
Who cannot join
- Not an actively employed first responder
- Does not currently reside in WV
- Not willing or able to participate
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Kanawha-Charleston Health Department
Charleston, West Virginia, 25301
Saint John XXIII Pastoral Center
Charleston, West Virginia, 25314
Marshall University
Huntington, West Virginia, 25755
West Virginia University
Morgantown, West Virginia, 26508
About this study
Official title: Intensive Mindfulness-based Resilience Training in First Responders: A Pilot Study
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.
Read the 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).
- Conditions
- Compassion Fatigue, Burnout, Stress, Mindfulness
- Being tested
- Mindfulness-Based Resilience Training
- Keywords
- First Responders
- Medical subject headings
- Compassion Fatigue, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Resilience TrainingBehavioural
2.5-day intensive MBRT training sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness-Based Resilience Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 90 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start24 Oct 2017
- Primary completion26 Jun 2018
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Compassion FatigueStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith Zullig, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929613
- Sponsor's protocol ID
- 1704554931
- Status last verified
- Jan 2024
- First submitted
- 2 Jun 2021
- Last updated
- 30 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Mindfulness-based Resilience Training in First Responders: A Pilot Study
- ClinicalTrials.gov ID
- NCT04929613
- Acronym / sponsor ID
- 1704554931
- Conditions
- Compassion Fatigue, Burnout, Stress, Mindfulness
- Keywords
- First Responders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Posted 30 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Resilience Training | Experimental | Behavioral: Mindfulness-Based Resilience TrainingDesigned 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current employment as a first responder
- West Virginia residency
- Availability/willingness to engage in a 2.5-day retreat style intervention on identified dates.
Key exclusion criteria (3 listed)
- Not an actively employed first responder
- Does not currently reside in WV
- Not willing or able to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Resilience Training2.5-day intensive MBRT training sessions. | Behavioural | Mindfulness-Based Resilience Training |
Primary outcome
Five Factor Mindfulness Questionnaire (FFMQ)
Time frame: Baseline
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.
Five Factor Mindfulness Questionnaire (FFMQ)
Time frame: Immediately following intervention
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.
Five Factor Mindfulness Questionnaire (FFMQ)
Time frame: 30 days post intervention
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.
Five Factor Mindfulness Questionnaire (FFMQ)
Time frame: 90 days post intervention
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.
Mindfulness Process Questionnaire (MPQ)
Time frame: Baseline
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.
Mindfulness Process Questionnaire (MPQ)
Time frame: Immediately following intervention
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.
Mindfulness Process Questionnaire (MPQ)
Time frame: 30 days post intervention
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.
Mindfulness Process Questionnaire (MPQ)
Time frame: 90 days post intervention
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.
Organizational Police Stress Questionnaire
Time frame: Baseline
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.
Organizational Police Stress Questionnaire
Time frame: Immediately following intervention
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.
Organizational Police Stress Questionnaire
Time frame: 30 days post intervention
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.
Organizational Police Stress Questionnaire
Time frame: 90 days post intervention
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.
Operational Police Stress Questionnaire
Time frame: Baseline
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.
Operational Police Stress Questionnaire
Time frame: Immediately following intervention
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.
Operational Police Stress Questionnaire
Time frame: 30 days post intervention
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.
Operational Police Stress Questionnaire
Time frame: 90 days post intervention
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.
Perceived Stress Scale (PSS)
Time frame: Baseline
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.
Perceived Stress Scale (PSS)
Time frame: Immediately following intervention
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.
Perceived Stress Scale (PSS)
Time frame: 30 days post intervention
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.
Perceived Stress Scale (PSS)
Time frame: 90 days post intervention
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.
Emotional Regulation
Time frame: Baseline
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.
Emotional Regulation
Time frame: Immediately following intervention
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.
Emotional Regulation
Time frame: 30 days post intervention
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.
Emotional Regulation
Time frame: 90 days post intervention
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.
Emotional Intelligence Scale
Time frame: Baseline
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.
Emotional Intelligence Scale
Time frame: Immediately following intervention
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.
Emotional Intelligence Scale
Time frame: 30 day post intervention
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.
Emotional Intelligence Scale
Time frame: 90 days
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.
Brief Resilience Scale
Time frame: Baseline
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.
Brief Resilience Scale
Time frame: Immediately following intervention
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.
Brief Resilience Scale
Time frame: 30 days post intervention
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.
Brief Resilience Scale
Time frame: 90 days post intervention
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.
General Family Functioning
Time frame: Baseline
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.
General Family Functioning
Time frame: Immediately following intervention
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.
General Family Functioning
Time frame: 30 days post intervention
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.
General Family Functioning
Time frame: 90 days post intervention
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.
PROMIS Sleep
Time frame: Baseline
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.
PROMIS Sleep
Time frame: Immediately following intervention
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.
PROMIS Sleep
Time frame: 30 days post intervention
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.
PROMIS Sleep
Time frame: 90 days post intervention
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.
PROMIS Health
Time frame: Baseline
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.
PROMIS Health
Time frame: Immediately following intervention
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.
PROMIS Health
Time frame: 30 days post intervention
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.
PROMIS Health
Time frame: 90 days post intervention
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.
PROMIS Fatigue
Time frame: Baseline
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.
PROMIS Fatigue
Time frame: Immediately following intervention
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.
PROMIS Fatigue
Time frame: 30 days post intervention
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.
PROMIS Fatigue
Time frame: 90 days post intervention
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.
PROMIS Anger
Time frame: Baseline
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.
PROMIS Anger
Time frame: Immediately following intervention
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.
PROMIS Anger
Time frame: 30 days post intervention
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.
PROMIS Anger
Time frame: 90 days post intervention
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Zullig, PhD principal investigator
West Virginia University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Resilience Training in people with Compassion Fatigue and Burnout, run by West Virginia University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five Factor Mindfulness Questionnaire (FFMQ) (time frame: Baseline). The study lists 52 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.