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Distress, EmotionalNCT05767970

Stress Toolbox for Healthcare Providers in Mexico

A study testing Integrated Stress Toolbox for Healthcare Providers (ISTH) in people with Distress, Emotional and Burnout, Professional, run by University of Wisconsin, Madison at 7 sites in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Integrated Stress Toolbox for Healthcare Providers (ISTH)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,315 participants
Where
7 sitesMexico
Study dates
4 Apr 2023to 29 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • <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 locations and contacts

7 sites in 1 country.

7 sites in 1 country

Mexico7 sites

  • Campeche State

    All, Campeche

  • Coahuila State

    All, Coahuila

  • Jalisco State

    All, Jalisco

  • Nuevo Leon State

    All, Nuevo León

  • Querétaro State

    All, Querétaro

  • Sonora State

    All, Sonora

  • Oaxaca State

    Oaxaca City

Other trials in Mexico

About this study

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:

Read more
  • 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.

Read the 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.

Being tested
Integrated Stress Toolbox for Healthcare Providers (ISTH)
Keywords
Well-being
Medical subject headings
Burnout, Professional, Inflammation, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Integrated Stress Toolbox for Healthcare Providers (ISTH)Behavioural

    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.

Study groups in NCT05767970
Study groupRoleWhat they receive
Integrated Stress Toolbox for Healthcare Providers (ISTH)ExperimentalA 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.
Receives: Behavioral: Integrated Stress Toolbox for Healthcare Providers (ISTH)
Wait-list controlNo interventionThe wait-list control group will continue with business as usual and receive the ISTH after the last data collection point.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (11)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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).

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

  5. 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.

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

  6. 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).

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

  7. 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.

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

  8. 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.

    Measured: Baseline, after weeks 8, 12 (post-intervention), 24 (three-month follow-up), and 36 (six-month follow-up)

  9. 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).

    Measured: Baseline, after weeks 1, 3, 8, and 12 (post-intervention).

  10. 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

    Measured: Baseline and afters weeks 8 and 12 (post-intervention).

  11. 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.

    Measured: Baseline, after weeks 12 (post-intervention) and 36 (six-month follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2023
  2. Study start4 Apr 2023
  3. Primary completion31 Mar 2024
  4. Study completion29 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Random permuted block parallel assignment
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
2,315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05767970
Sponsor's protocol ID
2023-0090
Other IDs
Center for Healthy Minds, L&S/PSYCHOLOGY/PSYCHOLOGY
Status last verified
Dec 2025
First submitted
28 Feb 2023
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 21697139

  • 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.

    PubMed 6668417

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

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

  • 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.

    PubMed 18310597

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

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

  • 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.

    PubMed 11811629

  • 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.

  • 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.

    PubMed 23133619

  • 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.

  • 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.

    PubMed 40824577

Questions about this trial

What is this clinical trial studying?

A study testing Integrated Stress Toolbox for Healthcare Providers (ISTH) in people with Distress, Emotional and Burnout, Professional, run by University of Wisconsin, Madison at 7 sites in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline on 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05767970, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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