Stress Toolbox for Healthcare Providers in Mexico
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,315
- 试验地点
- 13
- 主要终点
- Change from baseline in well-being
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 18 years old
- •Employee in a participating healthcare system in a participating Mexican State
排除标准
- •<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
结局指标
主要结局
Change from baseline in well-being
时间窗: baseline, after weeks 1, 3, 5, 8 ,12 (post intervention), 24 (3 months post-intervention), and 36 (six-months post-intervention)
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.
Change From Baseline on Psychological distress
时间窗: baseline, after weeks 1, 3, 5, 8 ,12 (post intervention), 24 (3 months post-intervention), and 36 (six-months post-intervention)
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.
次要结局
- Change from baseline on the Cognitive Emotion Regulation Questionnaire positive reappraisal subscale(baseline, after weeks 3, 5, 8, and 12 (post intervention))
- Change from baseline on the Maslach Burnout Inventory emotional exhaustion and personal accomplishment subscales(Baseline, after weeks 8, 12 (post-intervention), 24 (three-month follow-up), and 36 (six-month follow-up))
- Change from baseline on the Interpersonal Reactivity Index empathic concern subscale(baseline, after weeks 5, 8, and 12 (post intervention))
- Change from basline on the Meaning in Life Questionnaire presence subscale(baseline, after weeks 1, 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 Multidimensional Assessment of Interoceptive Awareness (MAIA) self-regulation subscale(Baseline, after weeks 1, 3, 8, and 12 (post-intervention).)
- 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 Gratitude Questionnaire-6(baseline, after weeks 5, 8, and 12 (post intervention))
- Change from baseline on the Compassionate Engagement and Action Scale Compassion for others subscale(Baseline and afters weeks 8 and 12 (post-intervention).)
- Change from baseline on the Global Assessments of Character Strengths 24(Baseline, after weeks 12 (post-intervention) and 36 (six-month follow-up))