Problem DrinkingNCT05629637
Feasibility and Acceptability of Mindfulness-based Resilience Training for Rural Law Enforcement Officers
A study testing Mindfulness-Based Resilience Training (MBRT) in people with Problem Drinking and Aggression, run by Pacific University at 1 site in United States.
Trial summary
Rural law enforcement officers (LEOs) are exposed to unique and significant stressors, yet have access to fewer resources, compared to urban counterparts, to mitigate harmful effects of stress. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Problem Drinking, Aggression, Stress, Psychological
- What is being tested?
- Mindfulness-Based Resilience Training (MBRT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 31 Aug 2024
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- be 21-65 years old,
- demonstrate English fluency,
- be a sworn, full-time, active status law enforcement officer, and
- be willing to complete assessments at multiple time points and attend intervention groups
Who cannot join
- previous participation in mindfulness-based stress reduction (MBSR), MBRT or a similar mindfulness course,
- endorse suicidal ideation, or
- unable or unwilling to give written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Mindfulness-based Resilience Training for Problematic Alcohol Use, Mental Health, and Aggression in Rural Law Enforcement Officers
Rural law enforcement officers (LEOs) are exposed to unique and significant stressors, yet have access to fewer resources, compared to urban counterparts, to mitigate harmful effects of stress. This elevates risk for maladaptive coping strategies such as problematic alcohol use, mental health consequences, and aggression and excessive use of force. The proposed supplement will assess feasibility and accessibility of Mindfulness-Based Resilience Training (MBRT), with added intervention components addressing alcohol use, in under-resourced rural LEOs to ensure success in a future multisite efficacy trial assessing effects of MBRT on mental health and behavioral outcomes.
Read the detailed description
The stress inherent to policing affects both officer health as well as the safety of their respective communities. The investigators current and previous research has shown that Mindfulness-Based Resilience Training (MBRT) leads to improvement in law enforcement officer (LEO) mental health and behavioral outcomes, including alcohol use and aggression. In the investigators current multisite R01 feasibility trial of MBRT, they have successfully met key feasibility and acceptability benchmarks in urban and suburban LEO samples. What is lacking is exploration of feasibility and acceptability in rural LEOs, who face unique stressors and challenges, and an integration of evidence-based preventive intervention components to directly target problematic alcohol use. Individuals living in rural communities are recognized as a target population for health disparities research. Rural LEOs experience stressors specific to rural populations such as isolation and work-role overload, yet often have fewer resources, including less access to stress management trainings and mental health care, compared to their urban and suburban counterparts. The combination of high stress coupled with low resources supporting mental health and performance may lead to increased reliance on maladaptive behaviors, such as excessive alcohol use. Indeed, LEOs have disproportionately higher rates of alcohol use, not only affecting their own health and wellbeing but also exacerbating effects of stress on aggression and excessive force in critical incidents. Preliminary evidence suggests alcohol use may be more problematic among rural, relative to urban, LEOs. The proposed supplement would support collection of data on feasibility and acceptability of MBRT in under-resourced rural LEOs to inform further adaptations to better serve this community. Additionally, the investigators propose to integrate specific elements of an evidence-based mindfulness intervention for substance use disorders to explicitly address problematic alcohol use and associated consequences among rural LEOs, enhancing effects of MBRT on officer health, and in turn reducing aggression and excessive use of force in critical incidents. Completion of supplement aims will strengthen support for a multisite trial of an intervention that holds great potential to reduce aggression and increase health and wellbeing among urban, suburban and rural LEOs and the communities they serve.
- Conditions
- Problem Drinking, Aggression, Stress, Psychological
- Being tested
- Mindfulness-Based Resilience Training (MBRT)
- Medical subject headings
- Alcoholism, Aggression, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Resilience Training (MBRT)Behavioural
MBRT is designed to enhance resilience in the presence of acute and chronic LEO stressors. MBRT will be delivered in a hybrid format. An intensive, 22-hour in-person training will be offered, followed by 4 weekly 90-minute zoom classes. The in-person portion of the training will span 3 days: 4 hours day 1, 6 hours day 2, and 6 hours day 3. MBRT contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions. MBRT is designed to address stressors inherent to police work, including critical incidents, job dissatisfaction, public scrutiny, and interpersonal, affective and behavioral challenges.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Resilience Training (MBRT) | Experimental | MBRT is an 2.5-day program combining training in standardized mindfulness practices targeting factors that facilitate resilience, cognitive-behavioral therapy (CBT), and psychoeducation. It contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions. Receives: Behavioral: Mindfulness-Based Resilience Training (MBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aggression
Buss-Perry Aggression Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater aggression.
Measured: baseline, post-intervention (4 weeks), 3 month followup
Change in Alcohol Use Negative Consequences
Patient Reported Outcome Measurement System (PROMIS) Alcohol Use Negative Consequences.Scores range from 39-77, with higher scores indicating greater alcohol use negative consequences.
Measured: baseline, post-intervention (4 weeks), 3 month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Feb 2023
- Primary completion15 May 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem DrinkingStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Michael Christopher, Principal investigator, Pacific University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629637
- Sponsor's protocol ID
- 090-18
- Other IDs
- 3R01AT009841-04S1
- Status last verified
- Nov 2024
- First submitted
- 16 Nov 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Mindfulness-based Resilience Training for Problematic Alcohol Use, Mental Health, and Aggression in Rural Law Enforcement Officers
- ClinicalTrials.gov ID
- NCT05629637
- Acronym / sponsor ID
- 090-18
- Conditions
- Problem Drinking, Aggression, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pacific UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 29 Nov 2022 (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.
Rural law enforcement officers (LEOs) are exposed to unique and significant stressors, yet have access to fewer resources, compared to urban counterparts, to mitigate harmful effects of stress. This elevates risk for maladaptive coping strategies such as problematic alcohol use, mental health consequences, and aggression and excessive use of force. The proposed supplement will assess feasibility and accessibility of Mindfulness-Based Resilience Training (MBRT), with added intervention components addressing alcohol use, in under-resourced rural LEOs to ensure success in a future multisite efficacy trial assessing effects of MBRT on mental health and behavioral outcomes.
Detailed description
The stress inherent to policing affects both officer health as well as the safety of their respective communities. The investigators current and previous research has shown that Mindfulness-Based Resilience Training (MBRT) leads to improvement in law enforcement officer (LEO) mental health and behavioral outcomes, including alcohol use and aggression. In the investigators current multisite R01 feasibility trial of MBRT, they have successfully met key feasibility and acceptability benchmarks in urban and suburban LEO samples. What is lacking is exploration of feasibility and acceptability in rural LEOs, who face unique stressors and challenges, and an integration of evidence-based preventive intervention components to directly target problematic alcohol use. Individuals living in rural communities are recognized as a target population for health disparities research. Rural LEOs experience stressors specific to rural populations such as isolation and work-role overload, yet often have fewer resources, including less access to stress management trainings and mental health care, compared to their urban and suburban counterparts. The combination of high stress coupled with low resources supporting mental health and performance may lead to increased reliance on maladaptive behaviors, such as excessive alcohol use. Indeed, LEOs have disproportionately higher rates of alcohol use, not only affecting their own health and wellbeing but also exacerbating effects of stress on aggression and excessive force in critical incidents. Preliminary evidence suggests alcohol use may be more problematic among rural, relative to urban, LEOs. The proposed supplement would support collection of data on feasibility and acceptability of MBRT in under-resourced rural LEOs to inform further adaptations to better serve this community. Additionally, the investigators propose to integrate specific elements of an evidence-based mindfulness intervention for substance use disorders to explicitly address problematic alcohol use and associated consequences among rural LEOs, enhancing effects of MBRT on officer health, and in turn reducing aggression and excessive use of force in critical incidents. Completion of supplement aims will strengthen support for a multisite trial of an intervention that holds great potential to reduce aggression and increase health and wellbeing among urban, suburban and rural LEOs and the communities they serve.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Resilience Training (MBRT) | Experimental | Behavioral: Mindfulness-Based Resilience Training (MBRT)MBRT is an 2.5-day program combining training in standardized mindfulness practices targeting factors that facilitate resilience, cognitive-behavioral therapy (CBT), and psychoeducation. It contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- be 21-65 years old,
- demonstrate English fluency,
- be a sworn, full-time, active status law enforcement officer, and
- be willing to complete assessments at multiple time points and attend intervention groups
Key exclusion criteria (3 listed)
- previous participation in mindfulness-based stress reduction (MBSR), MBRT or a similar mindfulness course,
- endorse suicidal ideation, or
- unable or unwilling to give written informed consent
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 Training (MBRT)MBRT is designed to enhance resilience in the presence of acute and chronic LEO stressors. MBRT will be delivered in a hybrid format. An intensive, 22-hour in-person training will be offered, followed by 4 weekly 90-minute zoom classes. The in-person portion of the training will span 3 days: 4 hours day 1, 6 hours day 2, and 6 hours day 3. MBRT contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions. MBRT is designed to address stressors inherent to police work, including critical incidents, job dissatisfaction, public scrutiny, and interpersonal, affective and behavioral challenges. | Behavioural | Mindfulness-Based Resilience Training (MBRT) |
Primary outcome
Change in Aggression
Time frame: baseline, post-intervention (4 weeks), 3 month followup
Buss-Perry Aggression Questionnaire-Short Form. Scores range from 1-5, with higher scores indicating greater aggression.
Change in Alcohol Use Negative Consequences
Time frame: baseline, post-intervention (4 weeks), 3 month followup
Patient Reported Outcome Measurement System (PROMIS) Alcohol Use Negative Consequences.Scores range from 39-77, with higher scores indicating greater alcohol use negative consequences.
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 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Michael Christopher principal investigator
Pacific University
1 site 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 (MBRT) in people with Problem Drinking and Aggression, run by Pacific University 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 12 Nov 2024. 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 Aggression (time frame: baseline, post-intervention (4 weeks), 3 month followup). 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?
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 12 Nov 2024.