Resilience Training for First Responders in the Opioid Epidemic

Stress Clinical Trial

Official title:

Intensive Mindfulness-based Resilience Training in First Responders: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04929613
• Other study ID #: 1704554931
• Status: Completed
• Phase: N/A
• Start date: October 24, 2017
• Est. completion date: June 26, 2018

Study information

• Verified date: January 2024
• Source: West Virginia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 26, 2018
• Est. primary completion date: June 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout
• Compassion Fatigue
• Mindfulness
• Stress

Intervention

Behavioral:
• Mindfulness-Based Resilience Training
2.5-day intensive MBRT training sessions.

Locations

Country	Name	City	State
United States	Kanawha-Charleston Health Department	Charleston	West Virginia
United States	Saint John XXIII Pastoral Center	Charleston	West Virginia
United States	Marshall University	Huntington	West Virginia
United States	West Virginia University	Morgantown	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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