Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05767970
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2023-02-28
Brief Title:
Stress Toolbox for Healthcare Providers in Mexico
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Stress Toolbox for Healthcare Providers in Mexico
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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 systemsclinics within Nuevo León Coahuila Oaxaca Querétaro Campeche Jalisco and Sonora may participate
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 ie 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 systemsclinics within Nuevo León Coahuila Oaxaca Querétaro Campeche Jalisco and Sonora may participate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| LSPSYCHOLOGYPSYCHOLOGY | OTHER | UW Madison | None |
| Center for Healthy Minds | OTHER | None | None |