Clinical trial NCT05767970: Stress Toolbox for Healthcare Providers in Mexico
Official title: Stress Toolbox for Healthcare Providers in Mexico
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Distress, Emotional
Burnout, Professional
Inflammation
Emotion Regulation
Keywords: Well-being
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Templeton World Charity Foundation, Inc
First posted: 2023-03-14
Enrollment: 2315
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random permuted block parallel assignment
Primary purpose: TREATMENT

Brief summary: The goal of this randomized wait-list clinical trial is to test in patient facing Mexican healthcare providers the efficacy of the Integrated Toolbox for Healthcare Providers (ISTH) on psychological functioning, well-being, occupational performance, and peripheral inflammation.

The main questions this study aims to answer are:

* Does assignment to the ISTH predict reduced psychological distress and increased well-being?
* Does assignment to the ISTH predict improved occupational outcomes and social-emotional competencies?

Participants will be randomly assigned to either the ISTH, a 12-week synchronous and app-based well-being training or to a wait-list control condition and complete assessments 8 times over the nine-month study period.

Researchers will compare the ISTH and the wait-list control group across time to evaluate ISTH impacts.

Detailed description: Using the random permuted block method, healthcare providers from up to six Mexican states in three tiers of healthcare facilities (low, middle, and high resource) will be randomly assigned to either the 12-week ISTH intervention or wait-list control.

The ISTH consists of eight, two-hour synchronous sessions (via ZOOM) that are recorded and available to participants on a private Youtube channel for one week. Class learning is reinforced through content provided on a special version of the Healthy Mind Program app designed for this study. Weeks 8-12 of the intervention are app only, with a final two-hour synchronous session at week 12. All study content (i.e., intervention, assessments) are in Spanish.

All participants will be asked to complete a baseline assessment battery, shorter assessments after weeks 1, 3, 5, and 8, and a battery of assessments after week 12 (post-intervention), after week 24 (three-month follow-up), and after week 36 (six-month follow-up).

Researchers will randomly sample from participants opting into the dried blood spot substudy 510 participants (255 per condition) for dried blood spot collection at baseline, after week 12, and after week 24. Researchers will randomly sample from participants opting into the patient satisfaction substudy patient satisfaction reports from 4-10 of their patients at baseline, after week 12 (post-intervention) and after week 24 (three-month follow-up). Researchers will prioritize that selected participants who opted into both substudies are enrolled in the substudies.

Healthcare systems/clinics within: Nuevo León, Coahuila, Oaxaca, Querétaro, Campeche, Jalisco, and Sonora may participate.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* Employee in a participating healthcare system in a participating Mexican State

Exclusion Criteria:

* \<18 years old
* Not in a participant healthcare system in a participating state
* Does not work in a qualifying healthcare provider role
* Does not have regular access to reliable internet and/or a smartphone capable of downloading the Healthy Minds Program app

Primary outcomes:
measure: Change From Baseline on Psychological distress
timeFrame: baseline, after weeks 1, 3, 5, 8 ,12 (post intervention), 24 (3 months post-intervention), and 36 (six-months post-intervention)
measure: Change from baseline in well-being
timeFrame: baseline, after weeks 1, 3, 5, 8 ,12 (post intervention), 24 (3 months post-intervention), and 36 (six-months post-intervention)
Secondary outcomes:
measure: Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness subscale
timeFrame: baseline, after weeks 1, 3, 8, and 12 (post intervention)
measure: Change From Baseline on the Five Facet Mindfulness Questionnaire Non-react to Inner Experience subscale
timeFrame: baseline, after weeks 3, 5, 8, and 12 (post intervention)
measure: Change from baseline on Healthy Minds Index subscales (awareness, connection, insight, and purpose)
timeFrame: baseline, after weeks 1, 3, 5, 8, and 12 (post intervention)
measure: Change from baseline on the Interpersonal Reactivity Index empathic concern subscale
timeFrame: baseline, after weeks 5, 8, and 12 (post intervention)
measure: Change from baseline on the Cognitive Emotion Regulation Questionnaire positive reappraisal subscale
timeFrame: baseline, after weeks 3, 5, 8, and 12 (post intervention)
measure: Change from baseline on the Gratitude Questionnaire-6
timeFrame: baseline, after weeks 5, 8, and 12 (post intervention)
measure: Change from basline on the Meaning in Life Questionnaire presence subscale
timeFrame: baseline, after weeks 1, 8 and 12 (post intervention)
measure: Change from baseline on the Maslach Burnout Inventory emotional exhaustion and personal accomplishment subscales
timeFrame: Baseline, after weeks 8, 12 (post-intervention), 24 (three-month follow-up), and 36 (six-month follow-up)
measure: Change from baseline on the Multidimensional Assessment of Interoceptive Awareness (MAIA) self-regulation subscale
timeFrame: Baseline, after weeks 1, 3, 8, and 12 (post-intervention).
measure: Change from baseline on the Compassionate Engagement and Action Scale Compassion for others subscale
timeFrame: Baseline and afters weeks 8 and 12 (post-intervention).
measure: Change from baseline on the Global Assessments of Character Strengths 24
timeFrame: Baseline, after weeks 12 (post-intervention) and 36 (six-month follow-up)
Other outcomes:
measure: Change from baseline on peripheral inflammation assessed via dried blood spots (CRP, IL-6, IL-10, TNFalpha)
timeFrame: Baseline, after week 12 (post-intervention), and after week 24 (three-month follow-up)
measure: Change from baseline on patient reports of satisfaction
timeFrame: Baseline and after weeks 12 (post-intervention) and 24 (three-month follow-up)
measure: Change from prior year to year after intervention on absenteeism.
timeFrame: Absenteeism year after week 24 assessment.
measure: Likelihood of same employment year after study
timeFrame: Employment year after week 24 assessment.
Locations:
city: All
country: Mexico
facility: Campeche State
state: Campeche
city: All
country: Mexico
facility: Coahuila State
state: Coahuila
city: All
country: Mexico
facility: Jalisco State
state: Jalisco
city: All
country: Mexico
facility: Nuevo Leon State
state: Nuevo Leon
city: All
country: Mexico
facility: Querétaro State
state: Querétaro
city: All
country: Mexico
facility: Sonora State
state: Sonora
city: Oaxaca
country: Mexico
facility: Oaxaca State
Study officials:
affiliation: AtentaMente
name: Leandro Chernicoff, MS
role: STUDY_DIRECTOR
References:
citation: Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.
citation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
citation: Bech, P. (2004). Measuring the dimension of psychological general well-being by the WHO-5. Quality of Life Newsletter, 15-16.
citation: Maslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach burnout inventory manual. Mountain View, CA: CPP. Inc., and Davies-Black.
citation: Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.
citation: Davis, M. H. (1980). Interpersonal reactivity index.
citation: Garnefski, N., & Kraaij, V. (2007). The cognitive emotion regulation questionnaire. European journal of psychological assessment, 23(3), 141-149.
citation: Mccullough ME, Emmons RA, Tsang JA. The grateful disposition: a conceptual and empirical topography. J Pers Soc Psychol. 2002 Jan;82(1):112-27. doi: 10.1037//0022-3514.82.1.112.
citation: Steger, M. F., Frazier, P., Oishi, S., & Kaler, M. (2006). The meaning in life questionnaire: assessing the presence of and search for meaning in life. Journal of counseling psychology, 53(1), 80.
citation: Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One. 2012;7(11):e48230. doi: 10.1371/journal.pone.0048230. Epub 2012 Nov 1.
citation: Gilbert, P., Catarino, F., Duarte, C., Matos, M., Kolts, R., Stubbs, J., ... & Basran, J. (2017). The development of compassionate engagement and action scales for self and others. Journal of Compassionate Health Care, 4, 1-24.