Stress, PsychologicalNCT03488875
Impact of Mindfulness Training on Stress-related Health Outcomes in Law Enforcement
A study testing mMBRT in people with Stress, Psychological and Sleep, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
In a sample of 120 officers from Dane County law enforcement agencies, the investigators are conducting a randomized controlled trial of an 8-week mindfulness-based training program for police officers, Madison Mindfulness-Based Resilience Training (mMBRT), and investigating the impact of this training on subjective… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Sleep, Inflammation
- What is being tested?
- mMBRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 10 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- At least 18 years of age
- Capable of giving informed consent
- Fluent in English
- Currently employed sworn law enforcement officer working in the Dane County Sheriff's Office, Madison Police Department, or University of Wisconsin-Madison Police Department.
Who cannot join
- Extensive prior experience in meditation practice, or previous completion of Mindfulness-Based Stress Reduction, Mindfulness-Based Resilience Training, or a substantively similar meditation training program
- A work schedule that precludes one from committing to regular participation in the 8-week training program
- Command staff working in a supervisory role
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Healthy Minds, University of Wisconsin-Madison
Madison, Wisconsin, 53703
About this study
Official title: The Impact of Mindfulness-Based Resilience Training on Stress-Related Biological, Behavioral, and Health-Related Outcomes in Law Enforcement Officers
In a sample of 120 officers from Dane County law enforcement agencies, the investigators are conducting a randomized controlled trial of an 8-week mindfulness-based training program for police officers, Madison Mindfulness-Based Resilience Training (mMBRT), and investigating the impact of this training on subjective responses to stress, stress-related psychological and physical health outcomes, and biological and behavioral correlates of perceived stress. While the benefits of mindfulness-based interventions have been documented in a variety of populations, this will be the largest and most comprehensive study of its kind of law enforcement personnel. In addition to self-report measures, this study assesses an array of objective biological and behavioral outcomes both in the laboratory and in the field that may speak to mechanisms of change involved in symptom reduction.
Read the detailed description
120 police officers will be recruited from Dane County law enforcement agencies to take part in an 8-week, group-based, mindfulness-based training program called Madison Mindfulness-Based Resilience Training (mMBRT). Officers will be randomized to an active group, which will receive mMBRT immediately after baseline assessments, and a waitlist control group, which will receive mMBRT after a post-intervention assessment and a subsequent follow-up assessment. mMBRT is similar to and inspired by MBRT, and both of these programs are law enforcement-specific interventions based on Mindfulness-Based Stress Reduction (MBSR), a commonly used mindfulness program in many healthcare settings. mMBRT is structurally similar to MBSR, with 8 weekly 2-hour classes involving guided meditation practices, gentle movement, and group-based discussion (one of these classes, toward the end of the course, is approximately 4 hours and integrates many of the practices and teachings covered throughout the training program). Participants will be provided with weekly homework assignments and audio recordings that provide guided instruction in various meditation and yoga practices.
At three separate timepoints, officers will take part in a laboratory assessment that involves the following procedures:
- administration of computerized behavioral tasks
- completion of self-report questionnaires that assess trauma history and occupational stressors, perceived stress, sleep, physical and mental health
- collection of a small amount of blood via finger prick and/or venipuncture (to assess peripheral inflammatory markers)
- collection of a small amount of hair from the scalp (to assess hair cortisol concentration)
- measurement of height and weight for the assessment of body mass index, and for use with activity trackers data
In conjunction with these laboratory assessments, data will be collected from officers in the field over the course of approximately 1 week (coinciding with a regularly scheduled work week), including the following procedures:
- officers will wear an activity monitor (e.g., Fitbit) to allow for objective monitoring of sleep quality and resting heart rate throughout the study
- officers will collect saliva samples 4 times per day over 3 days for the assessment of salivary cortisol
- officers will complete daily logs of work hours, types of events encountered during work, perceived stress related to these events, and self-reported mood and affect ratings
These field data will be related to dispatch records, which will provide objective information regarding the types of incidents responded to, and the time and location of these incidents.
The laboratory and field assessments will be collected at baseline (prior to randomization); after the active mMBRT group completes the intervention; and at a follow-up visit (approximately 4 months after the end of the intervention), after which the wait-list group will be offered the intervention.
- Conditions
- Stress, Psychological, Sleep, Inflammation, Mental Health
- Being tested
- mMBRT
- Medical subject headings
- Stress, Psychological, Inflammation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mMBRTBehavioural
Also called Madison Mindfulness-Based Resilience Training, MBRT
Madison Mindfulness-Based Resilience Training (mMBRT) is an 8-week mindfulness-based intervention developed specifically for police officers, which is similar to and inspired by a program developed by researchers at Pacific (OR) University (Christopher, Goerling et al., 2016). mMBRT includes 8 weekly 2-hour classes involving guided meditation practice, gentle movement, and group-based discussion (the 7th class is a longer, 4-hour class). The total class time is about 18 hours over 8 weeks, and participants are asked to engage in home practice for up to 30 minutes/day, 6 days/week throughout the intervention.
| Study group | Role | What they receive |
|---|---|---|
| mMBRT | Experimental | Individuals in the mMBRT group will receive an 8-week mindfulness-based intervention in groups of approximately 15 individuals in 8 weekly 2-hour classes (one of these classes, toward the end of the course, is approximately 4 hours and integrates many of the practices and teachings covered throughout the training program). Receives: Behavioral: mMBRT |
| Waitlist control group | No intervention | Individuals in the waitlist control group will complete the same assessments as those in the active treatment group, but will not be offered any intervention until the conclusion of the trial. At this time, control group participants will be offered the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived occupational stress
Change in combined scores of perceived operational and organizational stressors from the Police Stress Questionnaire (McCreary \& Thompson, 2004) from baseline to 3 months. Each of these 2 scales has 20 items with 1-7 ratings, where higher scores indicate greater stress (1=no stress at all, 7=A lot of stress). Organizational and operational stress scales will be summed to create a single value with a range of 40-280.
Measured: Baseline, post-intervention (3 months)
Change in diurnal cortisol slope
Saliva samples collected on each of 3 days will be used to calculate diurnal cortisol slope, defined as the change between the peak cortisol response in the 45 minutes after awakening and cortisol levels just prior to bedtime, with a hypothesized steeper slope in the intervention vs. waitlist group at post-intervention (3 months) vs. baseline.
Measured: Baseline, post-intervention (3 months)
Secondary outcomes (5)
Change in cortisol awakening response
The cortisol awakening response (CAR) will be measured using saliva samples collected 0, 30, and 45 minutes after awakening on each of 3 days, with hypothesized increased CAR in the intervention vs. waitlist group at post-intervention (3 months) vs. baseline.
Measured: Baseline, post-intervention (3 months)
Change in peripheral inflammatory markers
Composite of hsCRP and 4-plex of pro-inflammatory cytokines (IL-6, IL-8, IL-10, TNF-alpha) is hypothesized to be lower in intervention vs. waitlist group at post-intervention (3 months) vs. baseline.
Measured: Baseline, post-intervention (3 months)
Change in hyperarousal symptoms
Change in hyperarousal symptoms from the PTSD Checklist for DSM-5 at post-intervention (3 months) vs. baseline
Measured: Baseline, post-intervention (3 months), follow-up (6 months)
Change in subjective sleep quality
Global scores on the Pittsburgh Sleep Quality Index (Buysse et al., 1988) will be compared at post-intervention (3 months) vs. baseline
Measured: Baseline, post-intervention (3 months)
Change in perceived stress
Changes in total scores from the Perceived Stress Scale (10-item version; Cohen et al., 1988) from baseline to 3 months.
Measured: Baseline, post-intervention (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start6 Mar 2018
- Primary completion1 Oct 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized to an active treatment group and a waitlist control group.
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Justice
- Responsible party
- Sponsor
- Investigators
- Daniel W Grupe, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488875
- Sponsor's protocol ID
- 2017-1529
- Other IDs
- 2017-R2-CX-0033, A483000, L&S
- Status last verified
- Jan 2020
- First submitted
- 22 Mar 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grupe DW, Stoller JL, Alonso C, McGehee C, Smith C, Mumford JA, Rosenkranz MA, Davidson RJ. The Impact of Mindfulness Training on Police Officer Stress, Mental Health, and Salivary Cortisol Levels. Front Psychol. 2021 Sep 3;12:720753. doi: 10.3389/fpsyg.2021.720753. eCollection 2021.
PubMed 34539521Chen S, Grupe DW. Trait Mindfulness Moderates the Association Between Stressor Exposure and Perceived Stress in Law Enforcement Officers. Mindfulness (N Y). 2021;12(9):2325-2338. doi: 10.1007/s12671-021-01707-4. Epub 2021 Aug 5.
PubMed 34377216
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Mindfulness-Based Resilience Training on Stress-Related Biological, Behavioral, and Health-Related Outcomes in Law Enforcement Officers
- ClinicalTrials.gov ID
- NCT03488875
- Acronym / sponsor ID
- 2017-1529
- Conditions
- Stress, Psychological, Sleep, Inflammation, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- U.S. Department of Justice
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a sample of 120 officers from Dane County law enforcement agencies, the investigators are conducting a randomized controlled trial of an 8-week mindfulness-based training program for police officers, Madison Mindfulness-Based Resilience Training (mMBRT), and investigating the impact of this training on subjective responses to stress, stress-related psychological and physical health outcomes, and biological and behavioral correlates of perceived stress. While the benefits of mindfulness-based interventions have been documented in a variety of populations, this will be the largest and most comprehensive study of its kind of law enforcement personnel. In addition to self-report measures, this study assesses an array of objective biological and behavioral outcomes both in the laboratory and in the field that may speak to mechanisms of change involved in symptom reduction.
Detailed description
120 police officers will be recruited from Dane County law enforcement agencies to take part in an 8-week, group-based, mindfulness-based training program called Madison Mindfulness-Based Resilience Training (mMBRT). Officers will be randomized to an active group, which will receive mMBRT immediately after baseline assessments, and a waitlist control group, which will receive mMBRT after a post-intervention assessment and a subsequent follow-up assessment. mMBRT is similar to and inspired by MBRT, and both of these programs are law enforcement-specific interventions based on Mindfulness-Based Stress Reduction (MBSR), a commonly used mindfulness program in many healthcare settings. mMBRT is structurally similar to MBSR, with 8 weekly 2-hour classes involving guided meditation practices, gentle movement, and group-based discussion (one of these classes, toward the end of the course, is approximately 4 hours and integrates many of the practices and teachings covered throughout the training program). Participants will be provided with weekly homework assignments and audio recordings that provide guided instruction in various meditation and yoga practices.
At three separate timepoints, officers will take part in a laboratory assessment that involves the following procedures:
- administration of computerized behavioral tasks
- completion of self-report questionnaires that assess trauma history and occupational stressors, perceived stress, sleep, physical and mental health
- collection of a small amount of blood via finger prick and/or venipuncture (to assess peripheral inflammatory markers)
- collection of a small amount of hair from the scalp (to assess hair cortisol concentration)
- measurement of height and weight for the assessment of body mass index, and for use with activity trackers data
In conjunction with these laboratory assessments, data will be collected from officers in the field over the course of approximately 1 week (coinciding with a regularly scheduled work week), including the following procedures:
- officers will wear an activity monitor (e.g., Fitbit) to allow for objective monitoring of sleep quality and resting heart rate throughout the study
- officers will collect saliva samples 4 times per day over 3 days for the assessment of salivary cortisol
- officers will complete daily logs of work hours, types of events encountered during work, perceived stress related to these events, and self-reported mood and affect ratings
These field data will be related to dispatch records, which will provide objective information regarding the types of incidents responded to, and the time and location of these incidents.
The laboratory and field assessments will be collected at baseline (prior to randomization); after the active mMBRT group completes the intervention; and at a follow-up visit (approximately 4 months after the end of the intervention), after which the wait-list group will be offered the intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to an active treatment group and a waitlist control group.
| Arm | Type | Receives |
|---|---|---|
| mMBRT | Experimental | Behavioral: mMBRTIndividuals in the mMBRT group will receive an 8-week mindfulness-based intervention in groups of approximately 15 individuals in 8 weekly 2-hour classes (one of these classes, toward the end of the course, is approximately 4 hours and integrates many of the practices and teachings covered throughout the training program). |
| Waitlist control group | No intervention | –Individuals in the waitlist control group will complete the same assessments as those in the active treatment group, but will not be offered any intervention until the conclusion of the trial. At this time, control group participants will be offered the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Capable of giving informed consent
- Fluent in English
- Currently employed sworn law enforcement officer working in the Dane County Sheriff's Office, Madison Police Department, or University of Wisconsin-Madison Police Department.
Key exclusion criteria (3 listed)
- Extensive prior experience in meditation practice, or previous completion of Mindfulness-Based Stress Reduction, Mindfulness-Based Resilience Training, or a substantively similar meditation training program
- A work schedule that precludes one from committing to regular participation in the 8-week training program
- Command staff working in a supervisory role
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 |
|---|---|---|
| mMBRTAlso: Madison Mindfulness-Based Resilience Training, MBRTMadison Mindfulness-Based Resilience Training (mMBRT) is an 8-week mindfulness-based intervention developed specifically for police officers, which is similar to and inspired by a program developed by researchers at Pacific (OR) University (Christopher, Goerling et al., 2016). mMBRT includes 8 weekly 2-hour classes involving guided meditation practice, gentle movement, and group-based discussion (the 7th class is a longer, 4-hour class). The total class time is about 18 hours over 8 weeks, and participants are asked to engage in home practice for up to 30 minutes/day, 6 days/week throughout the intervention. | Behavioural | mMBRT |
Primary outcome
Change in perceived occupational stress
Time frame: Baseline, post-intervention (3 months)
Change in combined scores of perceived operational and organizational stressors from the Police Stress Questionnaire (McCreary \& Thompson, 2004) from baseline to 3 months. Each of these 2 scales has 20 items with 1-7 ratings, where higher scores indicate greater stress (1=no stress at all, 7=A lot of stress). Organizational and operational stress scales will be summed to create a single value with a range of 40-280.
Change in diurnal cortisol slope
Time frame: Baseline, post-intervention (3 months)
Saliva samples collected on each of 3 days will be used to calculate diurnal cortisol slope, defined as the change between the peak cortisol response in the 45 minutes after awakening and cortisol levels just prior to bedtime, with a hypothesized steeper slope in the intervention vs. waitlist group at post-intervention (3 months) vs. baseline.
5 secondary outcomes
Change in cortisol awakening response
Time frame: Baseline, post-intervention (3 months)
Change in peripheral inflammatory markers
Time frame: Baseline, post-intervention (3 months)
Change in hyperarousal symptoms
Time frame: Baseline, post-intervention (3 months), follow-up (6 months)
Change in subjective sleep quality
Time frame: Baseline, post-intervention (3 months)
Change in perceived stress
Time frame: Baseline, post-intervention (3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 34539521Grupe DW, Stoller JL, Alonso C, McGehee C, Smith C, Mumford JA, Rosenkranz MA, Davidson RJ. The Impact of Mindfulness Training on Police Officer Stress, Mental Health, and Salivary Cortisol Levels. Front Psychol. 2021 Sep 3;12:720753. doi: 10.3389/fpsyg.2021.720753. eCollection 2021.
- Derived from this study: PubMed 34377216Chen S, Grupe DW. Trait Mindfulness Moderates the Association Between Stressor Exposure and Perceived Stress in Law Enforcement Officers. Mindfulness (N Y). 2021;12(9):2325-2338. doi: 10.1007/s12671-021-01707-4. Epub 2021 Aug 5.
Related trials for Stress, Psychological
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
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.
Daniel W Grupe, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mMBRT in people with Stress, Psychological and Sleep, run by University of Wisconsin, Madison at 1 site 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 4 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in perceived occupational stress (time frame: Baseline, post-intervention (3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03488875, which also lists 2 linked publications.
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 18 Jan 2020.