Occupational StressNCT05608889
Corrections Work's Adverse Effects and a Total Worker Health Program to Enhance Well-being
A study testing Total Worker Health Mindfulness Enhanced Program in people with Occupational Stress and Health Behavior, run by Kerry Kuehl at 2 sites in United States.
Trial summary
Conduct a quasi-experimental pre-post study of a mindfulness-enhanced, web/app-enabled, scalable Total Worker Health (TWH) program among higher stress Corrections Professionals. The primary outcomes relate to behaviors promoted by the program: being mindful/reduced stress/improved mood; healthier eating; more physical… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Occupational Stress, Health Behavior, Safety Issues
- What is being tested?
- Total Worker Health Mindfulness Enhanced Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Nov 2022to 31 Dec 2023
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently employed as a corrections professional at participating Oregon Department of Corrections facilities (Coffee Creek Correctional Facility and Oregon State Correctional Institution) for at least one month
Who cannot join
- Those who are not employed with participating Oregon Department of Corrections facilities listed above.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Oregon State Correctional Institute
Salem, Oregon, 97310
Kerry Kuehl, 503-494-5991, kuehlk@ohsu.edu
- Recruiting
Coffee Creek Correctional Facility
Wilsonville, Oregon, 97070
Kerry Kuehl, 503-494-5991, kuehlk@ohsu.edu
About this study
Conduct a quasi-experimental pre-post study of a mindfulness-enhanced, web/app-enabled, scalable Total Worker Health (TWH) program among higher stress Corrections Professionals. The primary outcomes relate to behaviors promoted by the program: being mindful/reduced stress/improved mood; healthier eating; more physical activity; greater restorative sleep; improved work-life balance and greater positive feelings about the organization.
Read the detailed description
This proposed project will assess an innovative, scalable total worker health and wellness intervention among high stress Corrections Professionals. As stated in the proposal request, organizational and interpersonal factors have been associated with significant stress among Corrections Professionals, but there is limited assessment of effective and feasible interventions to mitigate these stress factors. Our current research has established robust constructs for characteristics of the organization and work environment, noting significant relationships with perceived stress. This critical understanding along with corresponding adverse mental and physical effects informs our proposed intervention to reduce potential stressors, enhance wellbeing, improve work performance, and reduce health care costs. This project will include a prospective interrupted time-series effectiveness trial of a mindfulness-enhanced, website/application-based, scalable Total Worker Health (TWH) program among higher risk corrections personnel working in restrictive housing units. Quantitative outcomes will include process measures; validated self-report indices of primary and secondary outcomes, and proximal potentially mediating factors; anthropometrics; laboratory studies of inflammation, vascular reactivity, and cellular aging; measures of job performance and health care costs. Qualitative measures will provide a deeper understanding of the quantitative findings. At program conclusion, there will be a cost effective easy to use work based health and wellness program tailored to corrections departments ready for dissemination. The robust dissemination plan includes coordinating the website and digital materials with the American Correctional Association marketing and media campaign site along with presentations at national corrections conferences making this freely available to all law enforcement and corrections personnel and agencies.
- Being tested
- Total Worker Health Mindfulness Enhanced Program
- Keywords
- Health Promotion, Mindfulness, Occupational Health, Total Worker Health, Safety
- Medical subject headings
- Occupational Stress, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Worker Health Mindfulness Enhanced ProgramBehavioural
The intervention will be delivered during 12, 45-minute weekly meetings of Correctional Professionals while on shift. Those sessions will be a combination of a video, mindfulness activity, and a group learning activity. It will conclude with members stating personal goals that will be followed up at the next meeting.
Sessions will be scripted to make them easy to implement with high fidelity, and include tasks, learning activities, and wrap-up with practice instructions for each week. Coworkers will be responsible for running the sessions, which promotes shared norms and social support.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Enhanced Web App-enabled Total Worker Health Program | Experimental | The Total Worker Health Mindful Program will include 12, 45-minute sessions completed each week at participant's workplace. Sessions will be guided by written curriculum and focus on healthy eating, exercise, sleep and stress reducing behaviors enhanced by mindfulness activities. Participants will be provided with free enrollment codes to use the Headspace® application (app). Receives: Behavioral: Total Worker Health Mindfulness Enhanced Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived stress
Perceived Stress Scale Short Form (PSS-4)
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Mood
The Positive and Negative Affect Schedule (PANAS); Profile of Mood States Short Form (POMS-SF)
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Eating Habits
Relevant excerpts from the National Cancer Institute's fruit and vegetable all day screener and Diet History Questionnaire (DHQ), percent calories from fat, and health dietary behaviors (Elliot et al., 2007; Kuehl et al., 2014)
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Physical Activity
Change in physical activity will be assessed using this survey question: "How many days per week did you exercise or take part in moderate physical activities that increased your breathing a bit for a total of at least 30 minutes during the day (such as brisk walking or bicycling)?". This is measured in days per week (with a scale of 0-7 days). Relevant excerpts from previous research on physical activity behaviors (Elliot et al., 2007).
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Sleep
Change in sleep will be assessed using this survey question: "In the past seven days, I had trouble sleeping" measures in a scale of 1-5 (1=very good, 2=good, 3=fair, 4=poor, 5=very poor). Short Form from the National Institutes of Health's Patient-Reported Outcomes Information System's Sleep Disturbance (PROMIS-SD-SF); Pittsburgh Sleep Quality Index (PSQI)
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Work-life balance
Change in work-life balance will be assessed using this survey question: "In the past month, how often have you felt that you were able to control the important things in your life?" measured in a scale of 1-5 (1=none of the time, 2=a little of the time, 3=some of the time, 4=most of the time, 5=all of the time). Ballin et al., 2021.
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Feelings about organization
Change in feelings about organization will be assessed using this survey question: "The Department of Corrections has processes in place that improve my work environment" measured with a scale from 1-5 (1=strongly disagree, 2=disagree, 3=neither disagree or agree, 4=agree, 5=strongly agree). Ballin et al., 2021.
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Secondary outcomes (10)
Change in Life Satisfaction
Change in life satisfaction will be assessed with the survey question: "Would you say your general health is:" with a scale of a)excellent, b)very good, c)good, d)fair, and e)poor.
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Body Mass Index
Change in Body mass index will measured in kg/m2.
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Blood Pressure
Changes in blood pressure will be measured in mmHg.
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Vascular Reactivity
Changes in Vascular reactivity will be measured in adjusted temperature rebound (aTR) between 0-2.
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in C-reactive Protein
Changes in C-reactive protein will be measured in mg/L.
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Cytokine Interleukin IL-6
Changes in cytokine Interleukin IL-6 will be measured in pg/mL.
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Tumour Necrosis Factor alpha
Changes in Tumour Necrosis Factor alpha will be measured in pg/mL.
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in telomere length
Changes in telomere length will be measured in kb.
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Worker's Compensation Claims
Change in Worker's Compensation Claims from Oregon Department of Corrections Human Resources data that report the number of worker's compensation claims there are.
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Days Injured
Change in Worker's Compensation Claims from Oregon Department of Corrections Human Resources data that report the number of missed days due to work-related illness or injury
Measured: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start9 Nov 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Occupational StressStudies 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
- Model description
- This study will use a quasi-experimental pre-post design to compare values of outcome measures at the three times points: baseline, immediately post-intervention (3 months after baseline), and follow-up (9 months after baseline). Randomization of the intervention is not feasible at the individual level due to contamination effects within a site and no appropriate control condition. Furthermore, as each of the sites is unique, a randomized cluster design would not be able to account for confounders since there are only three sites, each with institutional differences. An advantage of the pre-post design is that each participant will act as their own control, increasing the power of the study.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kerry Kuehl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kerry Kuehl, Oregon Health and Science University
- Investigators
- Kerry S. Kuehl, MD, DrPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608889
- Sponsor's protocol ID
- 2020-R2-CX-0006
- Other IDs
- 2020-R2-CX-0006
- Status last verified
- Feb 2023
- First submitted
- 25 Oct 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elliot DL, Goldberg L, Kuehl KS, Moe EL, Breger RK, Pickering MA. The PHLAME (Promoting Healthy Lifestyles: Alternative Models' Effects) firefighter study: outcomes of two models of behavior change. J Occup Environ Med. 2007 Feb;49(2):204-13. doi: 10.1097/JOM.0b013e3180329a8d.
PubMed 17293760Kuehl KS, Elliot DL, Goldberg L, MacKinnon DP, Vila BJ, Smith J, Miocevic M, O'Rourke HP, Valente MJ, DeFrancesco C, Sleigh A, McGinnis W. The safety and health improvement: enhancing law enforcement departments study: feasibility and findings. Front Public Health. 2014 May 8;2:38. doi: 10.3389/fpubh.2014.00038. eCollection 2014.
PubMed 24847475Cherniack M, Dussetschleger J, Dugan A, Farr D, Namazi S, El Ghaziri M, Henning R. Participatory action research in corrections: The HITEC 2 program. Appl Ergon. 2016 Mar;53 Pt A(Pt A):169-80. doi: 10.1016/j.apergo.2015.09.011. Epub 2015 Nov 2.
PubMed 26542616Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.
PubMed 27687118Elliot DL, Mackinnon DP, Mabry L, Kisbu-Sakarya Y, Defrancesco CA, Coxe SJ, Kuehl KS, Moe EL, Goldberg L, Favorite KC. Worksite wellness program implementation: a model of translational effectiveness. Transl Behav Med. 2012 Jun;2(2):228-35. doi: 10.1007/s13142-012-0121-z.
PubMed 24073114Hammer LB, Ernst Kossek E, Bodner T, Crain T. Measurement development and validation of the Family Supportive Supervisor Behavior Short-Form (FSSB-SF). J Occup Health Psychol. 2013 Jul;18(3):285-96. doi: 10.1037/a0032612. Epub 2013 Jun 3.
PubMed 23730803Hammer LB, Truxillo DM, Bodner T, Rineer J, Pytlovany AC, Richman A. Effects of a Workplace Intervention Targeting Psychosocial Risk Factors on Safety and Health Outcomes. Biomed Res Int. 2015;2015:836967. doi: 10.1155/2015/836967. Epub 2015 Oct 18.
PubMed 26557703MacKinnon DP, Elliot DL, Thoemmes F, Kuehl KS, Moe EL, Goldberg L, Burrell GL, Ranby KW. Long-term effects of a worksite health promotion program for firefighters. Am J Health Behav. 2010 Nov-Dec;34(6):695-706. doi: 10.5993/ajhb.34.6.6.
PubMed 20604695Olson R, Wipfli B, Thompson SV, Elliot DL, Anger WK, Bodner T, Hammer LB, Perrin NA. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States. Am J Public Health. 2016 Sep;106(9):1698-706. doi: 10.2105/AJPH.2016.303262. Epub 2016 Jul 27.
PubMed 27463067Rohlman DS, Parish M, Elliot DL, Hanson G, Perrin N. Addressing Younger Workers' Needs: The Promoting U through Safety and Health (PUSH) Trial Outcomes. Healthcare (Basel). 2016 Aug 10;4(3):55. doi: 10.3390/healthcare4030055.
PubMed 27517968Tang YY, Yang L, Leve LD, Harold GT. Improving Executive Function and its Neurobiological Mechanisms through a Mindfulness-Based Intervention: Advances within the Field of Developmental Neuroscience. Child Dev Perspect. 2012 Dec;6(4):361-366. doi: 10.1111/j.1750-8606.2012.00250.x.
PubMed 25419230Uegaki K, de Bruijne MC, van der Beek AJ, van Mechelen W, van Tulder MW. Economic evaluations of occupational health interventions from a company's perspective: a systematic review of methods to estimate the cost of health-related productivity loss. J Occup Rehabil. 2011 Mar;21(1):90-9. doi: 10.1007/s10926-010-9258-0.
PubMed 20668923von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies. Int J Surg. 2014 Dec;12(12):1495-9. doi: 10.1016/j.ijsu.2014.07.013. Epub 2014 Jul 18.
PubMed 25046131Zweber ZM, Henning RA, Magley VJ. A practical scale for Multi-Faceted Organizational Health Climate Assessment. J Occup Health Psychol. 2016 Apr;21(2):250-9. doi: 10.1037/a0039895. Epub 2015 Nov 16.
PubMed 26569133Elliot D, Kuehl K, DeFrancesco C, McGinnis W, Ek S, Van Horne A, Kempany KG. Technology-Enabled Intervention to Enhance Mindfulness, Safety, and Health Promotion Among Corrections Professionals: Protocol for a Prospective Quasi-Experimental Trial. JMIR Res Protoc. 2023 Sep 22;12:e45535. doi: 10.2196/45535.
PubMed 36602914
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corrections Work's Adverse Effects and a Total Worker Health Program to Enhance Well-being
- ClinicalTrials.gov ID
- NCT05608889
- Acronym / sponsor ID
- 2020-R2-CX-0006
- Keywords
- Health Promotion, Mindfulness, Occupational Health, Total Worker Health, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kerry KuehlUniversity, hospital or other
- Study start
- 9 Nov 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 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.
Conduct a quasi-experimental pre-post study of a mindfulness-enhanced, web/app-enabled, scalable Total Worker Health (TWH) program among higher stress Corrections Professionals. The primary outcomes relate to behaviors promoted by the program: being mindful/reduced stress/improved mood; healthier eating; more physical activity; greater restorative sleep; improved work-life balance and greater positive feelings about the organization.
Detailed description
This proposed project will assess an innovative, scalable total worker health and wellness intervention among high stress Corrections Professionals. As stated in the proposal request, organizational and interpersonal factors have been associated with significant stress among Corrections Professionals, but there is limited assessment of effective and feasible interventions to mitigate these stress factors. Our current research has established robust constructs for characteristics of the organization and work environment, noting significant relationships with perceived stress. This critical understanding along with corresponding adverse mental and physical effects informs our proposed intervention to reduce potential stressors, enhance wellbeing, improve work performance, and reduce health care costs. This project will include a prospective interrupted time-series effectiveness trial of a mindfulness-enhanced, website/application-based, scalable Total Worker Health (TWH) program among higher risk corrections personnel working in restrictive housing units. Quantitative outcomes will include process measures; validated self-report indices of primary and secondary outcomes, and proximal potentially mediating factors; anthropometrics; laboratory studies of inflammation, vascular reactivity, and cellular aging; measures of job performance and health care costs. Qualitative measures will provide a deeper understanding of the quantitative findings. At program conclusion, there will be a cost effective easy to use work based health and wellness program tailored to corrections departments ready for dissemination. The robust dissemination plan includes coordinating the website and digital materials with the American Correctional Association marketing and media campaign site along with presentations at national corrections conferences making this freely available to all law enforcement and corrections personnel and agencies.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will use a quasi-experimental pre-post design to compare values of outcome measures at the three times points: baseline, immediately post-intervention (3 months after baseline), and follow-up (9 months after baseline). Randomization of the intervention is not feasible at the individual level due to contamination effects within a site and no appropriate control condition. Furthermore, as each of the sites is unique, a randomized cluster design would not be able to account for confounders since there are only three sites, each with institutional differences. An advantage of the pre-post design is that each participant will act as their own control, increasing the power of the study.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Enhanced Web App-enabled Total Worker Health Program | Experimental | Behavioral: Total Worker Health Mindfulness Enhanced ProgramThe Total Worker Health Mindful Program will include 12, 45-minute sessions completed each week at participant's workplace. Sessions will be guided by written curriculum and focus on healthy eating, exercise, sleep and stress reducing behaviors enhanced by mindfulness activities. Participants will be provided with free enrollment codes to use the Headspace® application (app). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Currently employed as a corrections professional at participating Oregon Department of Corrections facilities (Coffee Creek Correctional Facility and Oregon State Correctional Institution) for at least one month
Key exclusion criteria (1 listed)
- Those who are not employed with participating Oregon Department of Corrections facilities listed above.
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 |
|---|---|---|
| Total Worker Health Mindfulness Enhanced ProgramThe intervention will be delivered during 12, 45-minute weekly meetings of Correctional Professionals while on shift. Those sessions will be a combination of a video, mindfulness activity, and a group learning activity. It will conclude with members stating personal goals that will be followed up at the next meeting. Sessions will be scripted to make them easy to implement with high fidelity, and include tasks, learning activities, and wrap-up with practice instructions for each week. Coworkers will be responsible for running the sessions, which promotes shared norms and social support. | Behavioural | Mindfulness Enhanced Web App-enabled Total Worker Health Program |
Primary outcome
Change in Perceived stress
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Perceived Stress Scale Short Form (PSS-4)
Change in Mood
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
The Positive and Negative Affect Schedule (PANAS); Profile of Mood States Short Form (POMS-SF)
Change in Eating Habits
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Relevant excerpts from the National Cancer Institute's fruit and vegetable all day screener and Diet History Questionnaire (DHQ), percent calories from fat, and health dietary behaviors (Elliot et al., 2007; Kuehl et al., 2014)
Change in Physical Activity
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in physical activity will be assessed using this survey question: "How many days per week did you exercise or take part in moderate physical activities that increased your breathing a bit for a total of at least 30 minutes during the day (such as brisk walking or bicycling)?". This is measured in days per week (with a scale of 0-7 days). Relevant excerpts from previous research on physical activity behaviors (Elliot et al., 2007).
Change in Sleep
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in sleep will be assessed using this survey question: "In the past seven days, I had trouble sleeping" measures in a scale of 1-5 (1=very good, 2=good, 3=fair, 4=poor, 5=very poor). Short Form from the National Institutes of Health's Patient-Reported Outcomes Information System's Sleep Disturbance (PROMIS-SD-SF); Pittsburgh Sleep Quality Index (PSQI)
Change in Work-life balance
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in work-life balance will be assessed using this survey question: "In the past month, how often have you felt that you were able to control the important things in your life?" measured in a scale of 1-5 (1=none of the time, 2=a little of the time, 3=some of the time, 4=most of the time, 5=all of the time). Ballin et al., 2021.
Change in Feelings about organization
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in feelings about organization will be assessed using this survey question: "The Department of Corrections has processes in place that improve my work environment" measured with a scale from 1-5 (1=strongly disagree, 2=disagree, 3=neither disagree or agree, 4=agree, 5=strongly agree). Ballin et al., 2021.
10 secondary outcomes
Change in Life Satisfaction
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Body Mass Index
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Blood Pressure
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Vascular Reactivity
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in C-reactive Protein
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Cytokine Interleukin IL-6
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Tumour Necrosis Factor alpha
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in telomere length
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Worker's Compensation Claims
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Change in Days Injured
Time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Background: PubMed 17293760Elliot DL, Goldberg L, Kuehl KS, Moe EL, Breger RK, Pickering MA. The PHLAME (Promoting Healthy Lifestyles: Alternative Models' Effects) firefighter study: outcomes of two models of behavior change. J Occup Environ Med. 2007 Feb;49(2):204-13. doi: 10.1097/JOM.0b013e3180329a8d.
- Background: PubMed 24847475Kuehl KS, Elliot DL, Goldberg L, MacKinnon DP, Vila BJ, Smith J, Miocevic M, O'Rourke HP, Valente MJ, DeFrancesco C, Sleigh A, McGinnis W. The safety and health improvement: enhancing law enforcement departments study: feasibility and findings. Front Public Health. 2014 May 8;2:38. doi: 10.3389/fpubh.2014.00038. eCollection 2014.
- Background: PubMed 26542616Cherniack M, Dussetschleger J, Dugan A, Farr D, Namazi S, El Ghaziri M, Henning R. Participatory action research in corrections: The HITEC 2 program. Appl Ergon. 2016 Mar;53 Pt A(Pt A):169-80. doi: 10.1016/j.apergo.2015.09.011. Epub 2015 Nov 2.
- Background: PubMed 27687118Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28.
- Background: PubMed 24073114Elliot DL, Mackinnon DP, Mabry L, Kisbu-Sakarya Y, Defrancesco CA, Coxe SJ, Kuehl KS, Moe EL, Goldberg L, Favorite KC. Worksite wellness program implementation: a model of translational effectiveness. Transl Behav Med. 2012 Jun;2(2):228-35. doi: 10.1007/s13142-012-0121-z.
- Background: PubMed 23730803Hammer LB, Ernst Kossek E, Bodner T, Crain T. Measurement development and validation of the Family Supportive Supervisor Behavior Short-Form (FSSB-SF). J Occup Health Psychol. 2013 Jul;18(3):285-96. doi: 10.1037/a0032612. Epub 2013 Jun 3.
- Background: PubMed 26557703Hammer LB, Truxillo DM, Bodner T, Rineer J, Pytlovany AC, Richman A. Effects of a Workplace Intervention Targeting Psychosocial Risk Factors on Safety and Health Outcomes. Biomed Res Int. 2015;2015:836967. doi: 10.1155/2015/836967. Epub 2015 Oct 18.
- Background: PubMed 20604695MacKinnon DP, Elliot DL, Thoemmes F, Kuehl KS, Moe EL, Goldberg L, Burrell GL, Ranby KW. Long-term effects of a worksite health promotion program for firefighters. Am J Health Behav. 2010 Nov-Dec;34(6):695-706. doi: 10.5993/ajhb.34.6.6.
- Background: PubMed 27463067Olson R, Wipfli B, Thompson SV, Elliot DL, Anger WK, Bodner T, Hammer LB, Perrin NA. Weight Control Intervention for Truck Drivers: The SHIFT Randomized Controlled Trial, United States. Am J Public Health. 2016 Sep;106(9):1698-706. doi: 10.2105/AJPH.2016.303262. Epub 2016 Jul 27.
- Background: PubMed 27517968Rohlman DS, Parish M, Elliot DL, Hanson G, Perrin N. Addressing Younger Workers' Needs: The Promoting U through Safety and Health (PUSH) Trial Outcomes. Healthcare (Basel). 2016 Aug 10;4(3):55. doi: 10.3390/healthcare4030055.
- Background: PubMed 25419230Tang YY, Yang L, Leve LD, Harold GT. Improving Executive Function and its Neurobiological Mechanisms through a Mindfulness-Based Intervention: Advances within the Field of Developmental Neuroscience. Child Dev Perspect. 2012 Dec;6(4):361-366. doi: 10.1111/j.1750-8606.2012.00250.x.
- Background: PubMed 20668923Uegaki K, de Bruijne MC, van der Beek AJ, van Mechelen W, van Tulder MW. Economic evaluations of occupational health interventions from a company's perspective: a systematic review of methods to estimate the cost of health-related productivity loss. J Occup Rehabil. 2011 Mar;21(1):90-9. doi: 10.1007/s10926-010-9258-0.
- Ballin, J. , Niederhausen, M. , Kuehl, K. , Elliot, D. , McGinnis, W. and DeFrancesco, C. (2021) Defining Stress among Corrections Professionals. Open Journal of Preventive Medicine, 11, 237-250. doi: 10.4236/ojpm.2021.116019.Link provided by the sponsor.
- 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.
Kerry S. Kuehl, MD, DrPH principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Worker Health Mindfulness Enhanced Program in people with Occupational Stress and Health Behavior, run by Kerry Kuehl at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerry S. Kuehl, MD, Dr.PH (503-494-5991, kuehlk@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived stress (time frame: Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion). The study lists 7 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 NCT05608889, which also lists 15 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 14 Feb 2023.