- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04929613
Resilience Training for First Responders in the Opioid Epidemic
Intensive Mindfulness-based Resilience Training in First Responders: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Virginia
-
Charleston, West Virginia, United States, 25301
- Kanawha-Charleston Health Department
-
Charleston, West Virginia, United States, 25314
- Saint John XXIII Pastoral Center
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Huntington, West Virginia, United States, 25755
- Marshall University
-
Morgantown, West Virginia, United States, 26508
- West Virginia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness-Based Resilience Training
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.
|
2.5-day intensive MBRT training sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Immediately following intervention
|
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.
|
30 days post intervention
|
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.
|
90 days post intervention
|
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.
|
Baseline
|
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.
|
Immediately following intervention
|
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.
|
30 days post intervention
|
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.
|
90 days post intervention
|
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.
|
Baseline
|
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.
|
Immediately following intervention
|
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.
|
30 days post intervention
|
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.
|
90 days post intervention
|
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.
|
Baseline
|
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.
|
Immediately following intervention
|
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.
|
30 days post intervention
|
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.
|
90 days post intervention
|
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.
|
Baseline
|
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.
|
Immediately following intervention
|
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.
|
30 days post intervention
|
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.
|
90 days post intervention
|
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.
|
Baseline
|
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.
|
Immediately following intervention
|
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.
|
30 days post intervention
|
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.
|
90 days post intervention
|
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.
|
Baseline
|
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.
|
Immediately following intervention
|
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.
|
30 day post intervention
|
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.
|
90 days
|
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.
|
Baseline
|
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.
|
Immediately following intervention
|
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.
|
30 days post intervention
|
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.
|
90 days post intervention
|
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.
|
Baseline
|
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.
|
Immediately following intervention
|
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.
|
30 days post intervention
|
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.
|
90 days post intervention
|
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.
|
Baseline
|
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.
|
Immediately following intervention
|
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.
|
30 days post intervention
|
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.
|
90 days post intervention
|
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.
|
Baseline
|
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.
|
Immediately following intervention
|
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.
|
30 days post intervention
|
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.
|
90 days post intervention
|
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.
|
Baseline
|
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.
|
Immediately following intervention
|
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.
|
30 days post intervention
|
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.
|
90 days post intervention
|
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.
|
Baseline
|
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.
|
Immediately following intervention
|
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.
|
30 days post intervention
|
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.
|
90 days post intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Keith Zullig, PhD, West Virginia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1704554931
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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