Choice and Autonomy in Learning Mindfulness for Pediatric Residents
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Wakeful Digital Mindfulness Program.
- Кому может быть актуально
- Состояния в реестре: Program Engagement, Treatment Adherence and Compliance, Mindfulness, Self-Compassion. Базовые параметры: Без ограничений · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study is a pilot clinical trial designed to evaluate a flexible, online mindfulness program for pediatric residents. Medical training can be stressful, and although mindfulness programs are often offered to support well-being, many are either in-person or follow a fixed format that may not fit individual schedules or preferences. This study will test a digital mindfulness program called Wakeful, which allows participants to complete the course at their own pace. Participants will be randomly assigned to one of two groups: one group will be able to choose the length of their mindfulness program (3, 5, or 7 weeks), while the other group will be assigned a program length without a choice. The goal is to understand whether giving participants a choice improves how often they use the program, how satisfied they are with it, and whether they complete it. The main outcomes of this study focus on how participants interact with the program, including how many sessions they complete, how often they practice mindfulness on their own, and how useful and relevant they find the program. The study will also look at overall satisfaction and how many participants drop out before finishing. In addition, the study will explore whether participants report changes in mindfulness and compassion for others, although it is not designed to determine clinical improvements in mental health. By understanding how pediatric residents engage with different program formats, this study aims to inform the design of more flexible and user-centered digital wellness programs that better fit into demanding medical training environments.
Подробное описание
This pilot randomized study evaluates the feasibility, acceptability, and user engagement of a digital, asynchronous mindfulness-based intervention (Wakeful) among pediatric residents. The study is designed to address a key limitation in existing mindfulness interventions: the predominance of "one-size-fits-all" program structures that may not align with the time constraints, preferences, and autonomy of medical trainees.
Background and Rationale
Pediatric residents experience significant occupational stress due to demanding clinical schedules, high patient volumes, and emotionally complex care environments. Although mindfulness-based interventions, including those derived from Mindfulness-Based Stress Reduction (MBSR), have demonstrated potential benefits, traditional in-person formats are often impractical for trainees. Digital mindfulness programs offer increased accessibility; however, engagement and adherence remain suboptimal.
A potential contributor to low engagement is the lack of personalization in program design. Most digital interventions prescribe a fixed duration and structure, without accounting for individual differences in time availability, motivation, or perceived burden. Allowing participants to choose key aspects of the intervention-such as program length-may enhance perceived autonomy and improve engagement and acceptability.
Study Objectives
The primary objective of this study is to evaluate whether offering participants a choice of intervention duration (3, 5, or 7 weeks) influences engagement, adherence, and acceptability of a digital mindfulness program.
Secondary exploratory objectives include assessing trends in self-reported mindfulness and compassion for others following participation in the program.
Study Design
This is a randomized, parallel-group pilot study conducted among pediatric residents at a single academic institution. Approximately 42 participants will be enrolled and randomized in a 1:1 ratio to one of two study arms:
Choice Arm (n = 21): Participants select their preferred program duration (3, 5, or 7 weeks).
No-Choice Arm (n = 21): Participants are assigned a program duration without input, using a matched randomization approach to ensure balanced distribution across durations.
Participants in both arms will complete one Wakeful session per week based on their assigned or selected schedule. Each session lasts approximately 45-60 minutes and includes didactic content, guided meditation, and optional reflective exercises.
Intervention
Wakeful is a web-based mindfulness program developed at Northwestern University. It delivers structured weekly content incorporating mindfulness principles, including attention awareness, emotional regulation, and loving-kindness practices. The platform includes guided meditations, educational materials, and optional community reflection features.
Participants may also engage in optional independent mindfulness practices outside of the structured sessions. All engagement occurs remotely, and participants may access the program via computer, tablet, or smartphone.
Data Collection and Outcome Measures Primary Outcomes (Engagement and Acceptability)
Primary outcomes focus on user interaction with the intervention and include:
Module completion rates Frequency and duration of platform use Independent meditation practice frequency Participant-reported usability and perceived relevance Satisfaction with the program Attrition and dropout rates
These measures will be derived from de-identified platform usage data and participant surveys.
Secondary (Exploratory) Outcomes
Exploratory outcomes include changes in:
Mindfulness (PROMIS Global Mindfulness Measure) Compassion for others (Neff Compassion Scale)
The study is not powered to detect statistically significant differences in psychological outcomes; these analyses are descriptive and hypothesis-generating.
Procedures
After providing informed consent, participants will be randomized to study arm. Those in the Choice Arm will select their preferred program duration, while those in the No-Choice Arm will be assigned a duration.
Participants will complete:
A baseline questionnaire prior to beginning the intervention A post-intervention questionnaire at program completion An optional in-person debrief interview 2-4 weeks after completion (subset of participants)
The debrief interviews will explore participant experiences, including factors influencing their engagement and perceptions of program structure.
Data Handling
All usage data collected by the Wakeful platform will be de-identified and linked only to a study ID. No personally identifiable information will be included in analytic datasets. Data will be stored on secure, encrypted servers, and only authorized study personnel will have access.
Significance
This study focuses on feasibility and user experience rather than clinical efficacy. By evaluating whether participant choice influences engagement, the findings will inform the design of future digital mindfulness interventions that prioritize flexibility, personalization, and alignment with the realities of medical training environments.
Вмешательства
- Поведенческое Wakeful Digital Mindfulness Program
Wakeful digital mindfulness program: an asynchronous, web-based course with guided meditations, didactic content, and optional reflective exercises.
Первичные конечные точки
- Engagement and completion of Wakeful program modules [Срок оценки: Baseline and immediately post-intervention (3, 5, or 7 weeks depending on program length)]
Вторичные конечные точки (1)
- Changes in mindfulness, self-compassion, and compassion for others [Срок оценки: Baseline and immediately post-intervention (3, 5, or 7 weeks depending on program length)]
Критерии участия
Критерии включения
- Current categorical pediatrics residents at Northwestern University.
- Preliminary pediatrics residents who intend to continue in pediatrics.
- Willing and able to provide informed consent.
Критерии исключения
\- None; all pediatric residents meeting inclusion criteria are eligible.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
США · 1 центр
- McGaw Medical Center — Chicago
Публикации
- Lebares CC, Hershberger AO, Guvva EV, Desai A, Mitchell J, Shen W, Reilly LM, Delucchi KL, O'Sullivan PS, Ascher NL, Harris HW. Feasibility of Formal Mindfulness-Based Stress-Resilience Training Among Surgery Interns: A Randomized Clinical Trial. JAMA Surg. 2018 Oct 1;153(10):e182734. doi: 10.1001/jamasurg.2018.2734. Epub 2018 Oct 17. PMID 30167655
- Brun C, Akinyemi A, Houtin L, Mizzi C, Cardoso T, Isnard Bagnis C. Mindfulness and compassion training for health professionals: A qualitative study. Front Psychol. 2023 Jan 12;13:1113453. doi: 10.3389/fpsyg.2022.1113453. eCollection 2022. PMID 36710842
- Fendel JC, Aeschbach VM, Schmidt S, Goritz AS. The impact of a tailored mindfulness-based program for resident physicians on distress and the quality of care: A randomised controlled trial. J Intern Med. 2021 Dec;290(6):1233-1248. doi: 10.1111/joim.13374. Epub 2021 Sep 23. PMID 34369618
- Verweij H, van Ravesteijn H, van Hooff MLM, Lagro-Janssen ALM, Speckens AEM. Does Mindfulness Training Enhance the Professional Development of Residents? A Qualitative Study. Acad Med. 2018 Sep;93(9):1335-1340. doi: 10.1097/ACM.0000000000002260. PMID 29697426
- Watts KJ, O'Connor M, Johnson CE, Breen LJ, Kane RT, Choules K, Doyle C, Buchanan G, Yuen K. Mindfulness-Based Compassion Training for Health Professionals Providing End-of-Life Care: Impact, Feasibility, and Acceptability. J Palliat Med. 2021 Sep;24(9):1364-1374. doi: 10.1089/jpm.2020.0358. Epub 2021 Mar 5. PMID 33666500
- Rojas B, Catalan E, Diez G, Roca P. A compassion-based program to reduce psychological distress in medical students: A pilot randomized clinical trial. PLoS One. 2023 Jun 23;18(6):e0287388. doi: 10.1371/journal.pone.0287388. eCollection 2023. PMID 37352295
- Victorson D, Morone NE, Pilkonis PA, Schalet B, Yu L, Jackson KL, Dodds N, Horowitz B, Johnston K, McFarland C, Klem ML, Sauer C, Choi S, Moskowitz JT, Ong JC, Addington EL, Satyshur MD, Suss SJ, Daehler S, Greco CM. Using PROMIS Methodology to Create Self-Report Measures of Mindfulness and Related Concepts. Glob Adv Integr Med Health. 2024 Oct 3;13:27536130241290771. doi: 10.1177/2753613024129077 PMID 39381495
Идентификаторы
NCT: NCT07542769 · STU00224541-MOD0001 · GR002591-01