Stress Toolbox for Healthcare Providers in Mexico

NCT05767970 | Completed

• 3 other identifiers: 2023-0090Center for Healthy MindsL&S/PSYCHOLOGY/PSYCHOLOGY
• Study Type: interventional
• Target: 2,315
• Locations: 1 country
• Sites: 7

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.

Conditions

Distress, Emotional; Burnout, Professional; Inflammation; Emotion Regulation

Keywords

Well-being

Outcome Measures

Primary Outcomes (2)

• Change From Baseline on Psychological distress

  Z-scored aggregate of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (a) and Anxiety (b) Scales, and the NIH Toolbox Perceived Stress v2.0 (c). A \& B: 8 item self-report scales. C: 10-item self-report. Higher scores indicate greater symptoms of psychological distress.

  baseline, after weeks 1, 3, 5, 8 ,12 (post intervention), 24 (3 months post-intervention), and 36 (six-months post-intervention)

• Change from baseline in well-being

  The World Health Organization Five Well-Being Index (WHO-5) is a short self-reported measure of current mental well-being (time frame the previous two weeks). The scale score range is 0 (lowest possible well-being) to 25 (highest possible well-being.

  baseline, after weeks 1, 3, 5, 8 ,12 (post intervention), 24 (3 months post-intervention), and 36 (six-months post-intervention)

Secondary Outcomes (11)

• Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness subscale

  baseline, after weeks 1, 3, 8, and 12 (post intervention)

• Change From Baseline on the Five Facet Mindfulness Questionnaire Non-react to Inner Experience subscale

  baseline, after weeks 3, 5, 8, and 12 (post intervention)

• Change from baseline on Healthy Minds Index subscales (awareness, connection, insight, and purpose)

  baseline, after weeks 1, 3, 5, 8, and 12 (post intervention)

• Change from baseline on the Interpersonal Reactivity Index empathic concern subscale

  baseline, after weeks 5, 8, and 12 (post intervention)

• Change from baseline on the Cognitive Emotion Regulation Questionnaire positive reappraisal subscale

  baseline, after weeks 3, 5, 8, and 12 (post intervention)

Other Outcomes (4)

• Change from baseline on peripheral inflammation assessed via dried blood spots (CRP, IL-6, IL-10, TNFalpha)

  Baseline, after week 12 (post-intervention), and after week 24 (three-month follow-up)

• Change from baseline on patient reports of satisfaction

  Baseline and after weeks 12 (post-intervention) and 24 (three-month follow-up)

• Change from prior year to year after intervention on absenteeism.

  Absenteeism year after week 24 assessment.

Study Arms (2)

Integrated Stress Toolbox for Healthcare Providers (ISTH)

EXPERIMENTAL

A 12-week synchronous and app-based well-being training that involves weekly 2-hour sessions for weeks 1-8 and at week 12, along with 12-weeks of app-based content delivered through a special version of the Healthy Minds Program app.

Behavioral: Integrated Stress Toolbox for Healthcare Providers (ISTH)

Wait-list control

NO INTERVENTION

The wait-list control group will continue with business as usual and receive the ISTH after the last data collection point.

Interventions

Integrated Stress Toolbox for Healthcare Providers (ISTH) BEHAVIORAL

The ISTH is a 12-week meditation-based well-being training. In weeks 1-8, participants engage in weekly 2-hour class sessions that are recorded and posted on a private Youtube channel for one week. There is a final two-hour session at week 12. In-class learning is augmented and extended through content in a special version of the Healthy Minds Program smartphone app that participants are asked to use on a daily basis throughout the intervention.

Integrated Stress Toolbox for Healthcare Providers (ISTH)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Templeton World Charity Foundation, Inc: collaborator
• University of Wisconsin, Madison: lead

Study Sites (7)

Campeche State

All, Campeche, Mexico

Location

Coahuila State

All, Coahuila, Mexico

Location

Jalisco State

All, Jalisco, Mexico

Location

Nuevo Leon State

All, Nuevo León, Mexico

Location

Querétaro State

All, Querétaro, Mexico

Location

Sonora State

All, Sonora, Mexico

Location

Oaxaca State

Oaxaca City, Mexico

Location

Related Publications (12)

• 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.

  PMID: 21697139 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• Bech, P. (2004). Measuring the dimension of psychological general well-being by the WHO-5. Quality of Life Newsletter, 15-16.

  BACKGROUND

• Maslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach burnout inventory manual. Mountain View, CA: CPP. Inc., and Davies-Black.

  BACKGROUND

• 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.

  PMID: 18310597 BACKGROUND

• Davis, M. H. (1980). Interpersonal reactivity index.

  BACKGROUND

• Garnefski, N., & Kraaij, V. (2007). The cognitive emotion regulation questionnaire. European journal of psychological assessment, 23(3), 141-149.

  BACKGROUND

• 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.

  PMID: 11811629 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23133619 BACKGROUND

• 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.

  BACKGROUND

• Hirshberg MJ, Davidson RJ, Velarde Arrisueno LB, Olvera Puentes JM, Bardalez XM, Gonzalez BS, Goldberg SB, Chernicoff LI; HCP-Well Study Group. Digital Well-Being Training With Health Care Professionals: A Randomized Clinical Trial. JAMA Intern Med. 2025 Aug 18;185(10):1248-56. doi: 10.1001/jamainternmed.2025.3888. Online ahead of print.

  PMID: 40824577 DERIVED

MeSH Terms

Conditions

Burnout, Professional; Inflammation; Emotional Regulation

Interventions

Health Personnel

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Self-Control; Social Behavior

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Leandro Chernicoff, MS

  AtentaMente

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Assessments will be collected online or through professional data collection service (for dried blood spots and patient satisfaction reports) that will be blind to condition assignment. The investigators responsible for data analysis will be blind to condition assignment until after primary analyses are complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random permuted block parallel assignment

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 14, 2023
• Study Start: April 4, 2023
• Primary Completion: March 31, 2024
• Study Completion: September 29, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After publication of primary outcomes paper
• Access Criteria: Data will be posted on a public repository (osf.io; e.g., to replicate published analyses) but use of the data in future publications will be at the discretion of the research team.

Locations

ME (7)