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Stress Toolbox for Healthcare Providers in Mexico

Primary Purpose

Distress, Emotional, Burnout, Professional, Inflammation

Status
Active
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Integrated Stress Toolbox for Healthcare Providers (ISTH)
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distress, Emotional focused on measuring Well-being

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Campeche State
  • Coahuila State
  • Jalisco State
  • Nuevo Leon State
  • Querétaro State
  • Sonora State
  • Oaxaca State

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Integrated Stress Toolbox for Healthcare Providers (ISTH)

Wait-list control

Arm 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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness subscale
A measure of acting with mindful awareness. Total possible scores range from 8-40, with higher scores indicating greater levels of the facet of mindfulness. This construct is specified as a mechanism of change.
Change From Baseline on the Five Facet Mindfulness Questionnaire Non-react to Inner Experience subscale
A measure of not reacting to experience. Total possible scores range from 8-40, with higher scores indicating greater levels of the facet of mindfulness. This construct is specified as a mechanism of change.
Change from baseline on Healthy Minds Index subscales (awareness, connection, insight, and purpose)
The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the four subscales range as follows: Awareness (0 to 16), Connection (0 to 24), Insight (0 to 12), Purpose (0 to 16) where higher scores indicate more of each quality. Insight is specified as a mechanism of change.
Change from baseline on the Interpersonal Reactivity Index empathic concern subscale
A 7-item self report that measures empathic concern (i.e., compassion/care for others). It is scored on a 1-5 scale with higher scores representing greater empathic concern (score range 7 - 35).
Change from baseline on the Cognitive Emotion Regulation Questionnaire positive reappraisal subscale
A 4-item self-report of positive reappraisal. Items are scored on a 1-5 scale (score ranges 4-20) with higher scores representing greater positive cognitive reappraisal of difficult situations. The measure is specified as a mechanism of change.
Change from baseline on the Gratitude Questionnaire-6
A 6-item self-report designed to test individual differences in one's propensity to experience gratitude in daily life. Items are scored on a 1 - 7 scale, with greater scores reflecting higher levels of gratitude (score range 7 - 42).
Change from basline on the Meaning in Life Questionnaire presence subscale
A 5-item self report scored on a 1-7 scale, with greater score representing higher levels of meaning in life day-to-day (score ranges (5 - 35). This construct is specified as a mechanism.
Change from baseline on the Maslach Burnout Inventory emotional exhaustion and personal accomplishment subscales
Burn-out is a syndrome conceptualized as resulting from chronic workplace stress that has not been successfully managed. Participants will use a 7-point frequency scale (ranging from 0-never to 6-daily) to indicate the extent to which they experienced each item (e.g., "I feel emotionally drained from my work."). Higher scores indicate higher degrees of burnout.
Change from baseline on the Multidimensional Assessment of Interoceptive Awareness (MAIA) self-regulation subscale
A 4-item self-report that assess one's ability to find a sense of calm amidst feelings of overwhelm and stress. Items are scored on a 0-5 scale with higher scores representing higher levels of self-regulation (score ranges 0 - 20).
Change from baseline on the Compassionate Engagement and Action Scale Compassion for others subscale
A 13-item self-report that assesses compassion for others on two dimensions, engagement and action. Scores range from 13 to 130 with higher scores representing greater levels of compassion
Change from baseline on the Global Assessments of Character Strengths 24
A 24 item self-report on 24 dimensions of character strengths scored on 1 - 7 scale.

Full Information

First Posted
February 28, 2023
Last Updated
September 29, 2023
Sponsor
University of Wisconsin, Madison
Collaborators
Templeton World Charity Foundation, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT05767970
Brief Title
Stress Toolbox for Healthcare Providers in Mexico
Official Title
Stress Toolbox for Healthcare Providers in Mexico
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 4, 2023 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Templeton World Charity Foundation, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distress, Emotional, Burnout, Professional, Inflammation, Emotion Regulation
Keywords
Well-being

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Random permuted block parallel assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
10000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated Stress Toolbox for Healthcare Providers (ISTH)
Arm Type
Experimental
Arm 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.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
The wait-list control group will continue with business as usual and receive the ISTH after the last data collection point.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Stress Toolbox for Healthcare Providers (ISTH)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline on Psychological distress
Description
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.
Time Frame
baseline, after weeks 1, 3, 5, 8 ,12 (post intervention), 24 (3 months post-intervention), and 36 (six-months post-intervention)
Title
Change from baseline in well-being
Description
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.
Time Frame
baseline, after weeks 1, 3, 5, 8 ,12 (post intervention), 24 (3 months post-intervention), and 36 (six-months post-intervention)
Secondary Outcome Measure Information:
Title
Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness subscale
Description
A measure of acting with mindful awareness. Total possible scores range from 8-40, with higher scores indicating greater levels of the facet of mindfulness. This construct is specified as a mechanism of change.
Time Frame
baseline, after weeks 1, 3, 8, and 12 (post intervention)
Title
Change From Baseline on the Five Facet Mindfulness Questionnaire Non-react to Inner Experience subscale
Description
A measure of not reacting to experience. Total possible scores range from 8-40, with higher scores indicating greater levels of the facet of mindfulness. This construct is specified as a mechanism of change.
Time Frame
baseline, after weeks 3, 5, 8, and 12 (post intervention)
Title
Change from baseline on Healthy Minds Index subscales (awareness, connection, insight, and purpose)
Description
The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the four subscales range as follows: Awareness (0 to 16), Connection (0 to 24), Insight (0 to 12), Purpose (0 to 16) where higher scores indicate more of each quality. Insight is specified as a mechanism of change.
Time Frame
baseline, after weeks 1, 3, 5, 8, and 12 (post intervention)
Title
Change from baseline on the Interpersonal Reactivity Index empathic concern subscale
Description
A 7-item self report that measures empathic concern (i.e., compassion/care for others). It is scored on a 1-5 scale with higher scores representing greater empathic concern (score range 7 - 35).
Time Frame
baseline, after weeks 5, 8, and 12 (post intervention)
Title
Change from baseline on the Cognitive Emotion Regulation Questionnaire positive reappraisal subscale
Description
A 4-item self-report of positive reappraisal. Items are scored on a 1-5 scale (score ranges 4-20) with higher scores representing greater positive cognitive reappraisal of difficult situations. The measure is specified as a mechanism of change.
Time Frame
baseline, after weeks 3, 5, 8, and 12 (post intervention)
Title
Change from baseline on the Gratitude Questionnaire-6
Description
A 6-item self-report designed to test individual differences in one's propensity to experience gratitude in daily life. Items are scored on a 1 - 7 scale, with greater scores reflecting higher levels of gratitude (score range 7 - 42).
Time Frame
baseline, after weeks 5, 8, and 12 (post intervention)
Title
Change from basline on the Meaning in Life Questionnaire presence subscale
Description
A 5-item self report scored on a 1-7 scale, with greater score representing higher levels of meaning in life day-to-day (score ranges (5 - 35). This construct is specified as a mechanism.
Time Frame
baseline, after weeks 1, 8 and 12 (post intervention)
Title
Change from baseline on the Maslach Burnout Inventory emotional exhaustion and personal accomplishment subscales
Description
Burn-out is a syndrome conceptualized as resulting from chronic workplace stress that has not been successfully managed. Participants will use a 7-point frequency scale (ranging from 0-never to 6-daily) to indicate the extent to which they experienced each item (e.g., "I feel emotionally drained from my work."). Higher scores indicate higher degrees of burnout.
Time Frame
Baseline, after weeks 8, 12 (post-intervention), 24 (three-month follow-up), and 36 (six-month follow-up)
Title
Change from baseline on the Multidimensional Assessment of Interoceptive Awareness (MAIA) self-regulation subscale
Description
A 4-item self-report that assess one's ability to find a sense of calm amidst feelings of overwhelm and stress. Items are scored on a 0-5 scale with higher scores representing higher levels of self-regulation (score ranges 0 - 20).
Time Frame
Baseline, after weeks 1, 3, 8, and 12 (post-intervention).
Title
Change from baseline on the Compassionate Engagement and Action Scale Compassion for others subscale
Description
A 13-item self-report that assesses compassion for others on two dimensions, engagement and action. Scores range from 13 to 130 with higher scores representing greater levels of compassion
Time Frame
Baseline and afters weeks 8 and 12 (post-intervention).
Title
Change from baseline on the Global Assessments of Character Strengths 24
Description
A 24 item self-report on 24 dimensions of character strengths scored on 1 - 7 scale.
Time Frame
Baseline, after weeks 12 (post-intervention) and 36 (six-month follow-up)
Other Pre-specified Outcome Measures:
Title
Change from baseline on peripheral inflammation assessed via dried blood spots (CRP, IL-6, IL-10, TNFalpha)
Description
A four-plex of pro-inflammatory cytokines assayed via dried blood spot analytes collected in a subsample (n=525) of participants. Peripheral inflammation is specified as an outcome and mechanism of change.
Time Frame
Baseline, after week 12 (post-intervention), and after week 24 (three-month follow-up)
Title
Change from baseline on patient reports of satisfaction
Description
An approximately 30 item questionnaire that a contracted agency with administer to between 4-10 patients of the subsample of participants that are enrolled in this substudy (n=525). Questions ask about overall satisfaction and levels of different provider (i.e., participant) qualities such as patience and empathy, amount of time the provider spent with the patient, quality of provider explanations, and the thoroughness of the provider's inquiry into the patients concerns.
Time Frame
Baseline and after weeks 12 (post-intervention) and 24 (three-month follow-up)
Title
Change from prior year to year after intervention on absenteeism.
Description
Absenteeism records
Time Frame
Absenteeism year after week 24 assessment.
Title
Likelihood of same employment year after study
Description
Year of study and year after study employment records to test career attrition/persistence.
Time Frame
Employment year after week 24 assessment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leandro Chernicoff, MS
Organizational Affiliation
AtentaMente
Official's Role
Study Director
Facility Information:
Facility Name
Campeche State
City
All
State/Province
Campeche
Country
Mexico
Facility Name
Coahuila State
City
All
State/Province
Coahuila
Country
Mexico
Facility Name
Jalisco State
City
All
State/Province
Jalisco
Country
Mexico
Facility Name
Nuevo Leon State
City
All
State/Province
Nuevo Leon
Country
Mexico
Facility Name
Querétaro State
City
All
State/Province
Querétaro
Country
Mexico
Facility Name
Sonora State
City
All
State/Province
Sonora
Country
Mexico
Facility Name
Oaxaca State
City
Oaxaca
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Prespecified hypotheses and analyses plans will be preregistered on osf.io prior to recruitment. De-identified study data will be posted on osf.io after publication of trial analyses. Code used in all publications will be available by request.
IPD Sharing Time Frame
After publication of primary outcomes paper
IPD Sharing 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.
Citations:
PubMed Identifier
21697139
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.
Results Reference
background
PubMed Identifier
6668417
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.
Results Reference
background
Citation
Bech, P. (2004). Measuring the dimension of psychological general well-being by the WHO-5. Quality of Life Newsletter, 15-16.
Results Reference
background
Citation
Maslach, C., Jackson, S. E., & Leiter, M. P. (1996). Maslach burnout inventory manual. Mountain View, CA: CPP. Inc., and Davies-Black.
Results Reference
background
PubMed Identifier
18310597
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.
Results Reference
background
Citation
Davis, M. H. (1980). Interpersonal reactivity index.
Results Reference
background
Citation
Garnefski, N., & Kraaij, V. (2007). The cognitive emotion regulation questionnaire. European journal of psychological assessment, 23(3), 141-149.
Results Reference
background
PubMed Identifier
11811629
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
23133619
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.
Results Reference
background
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.
Results Reference
background

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Stress Toolbox for Healthcare Providers in Mexico

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