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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05608889
Other study ID # 2020-R2-CX-0006
Secondary ID 2020-R2-CX-0006
Status Recruiting
Phase N/A
First received
Last updated
Start date November 9, 2022
Est. completion date December 31, 2023

Study information

Verified date February 2023
Source Oregon Health and Science University
Contact Kerry S. Kuehl, MD, Dr.PH
Phone 503-494-5991
Email kuehlk@ohsu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 activity; greater restorative sleep; improved work-life balance and greater positive feelings about the organization.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Those who are not employed with participating Oregon Department of Corrections facilities listed above.

Study Design


Intervention

Behavioral:
Total Worker Health Mindfulness Enhanced Program
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.

Locations

Country Name City State
United States Oregon State Correctional Institute Salem Oregon
United States Coffee Creek Correctional Facility Wilsonville Oregon

Sponsors (1)

Lead Sponsor Collaborator
Kerry Kuehl

Country where clinical trial is conducted

United States, 

References & Publications (14)

Cherniack 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:169-80. doi: 10.1016/j.apergo.2015.09.011. Epub 2015 Nov 2. — View Citation

Creswell JD. Mindfulness Interventions. Annu Rev Psychol. 2017 Jan 3;68:491-516. doi: 10.1146/annurev-psych-042716-051139. Epub 2016 Sep 28. — View Citation

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. — View Citation

Elliot 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. — View Citation

Hammer 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. — View Citation

Hammer 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. — View Citation

Kuehl 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. — View Citation

MacKinnon 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. — View Citation

Olson 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. — View Citation

Rohlman 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. — View Citation

Tang 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. — View Citation

Uegaki 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. — View Citation

von 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. — View Citation

Zweber 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. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Perceived stress Perceived Stress Scale Short Form (PSS-4) Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Primary Change in Mood The Positive and Negative Affect Schedule (PANAS); Profile of Mood States Short Form (POMS-SF) Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Primary 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) Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Primary 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). Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Primary 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) Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Primary 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. Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Primary 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. Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Secondary 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. Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Secondary Change in Body Mass Index Change in Body mass index will measured in kg/m2. Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Secondary Change in Blood Pressure Changes in blood pressure will be measured in mmHg. Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Secondary Change in Vascular Reactivity Changes in Vascular reactivity will be measured in adjusted temperature rebound (aTR) between 0-2. Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Secondary Change in C-reactive Protein Changes in C-reactive protein will be measured in mg/L. Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Secondary Change in Cytokine Interleukin IL-6 Changes in cytokine Interleukin IL-6 will be measured in pg/mL. Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Secondary Change in Tumour Necrosis Factor alpha Changes in Tumour Necrosis Factor alpha will be measured in pg/mL. Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Secondary Change in telomere length Changes in telomere length will be measured in kb. Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Secondary 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. Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
Secondary 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 Change between timepoints: Before intervention implementation, 3 months after the intervention completion, and 9 months after intervention completion
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