Stress Toolbox for Healthcare Providers in Mexico

University of Wisconsin (UW)

Status: Completed

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

Treatments: Behavioral: Integrated Stress Toolbox for Healthcare Providers (ISTH)

Study type: Interventional

Funder types: Other

Identifiers

NCT05767970

L&S/PSYCHOLOGY/PSYCHOLOGY (Other Identifier)

2023-0090

Center for Healthy Minds (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,315 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,315 participants in 2 patient groups

Integrated Stress Toolbox for Healthcare Providers (ISTH)

Experimental group

Description:

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.

Treatment:

Behavioral: Integrated Stress Toolbox for Healthcare Providers (ISTH)

Wait-list control

No Intervention group

Description:

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