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临床试验/NCT07542769
NCT07542769招募中不适用

Choice and Autonomy in Learning Mindfulness for Pediatric Residents

Northwestern University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年4月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
1
主要终点
Engagement and completion of Wakeful program modules

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Current categorical pediatrics residents at Northwestern University.
  • Preliminary pediatrics residents who intend to continue in pediatrics.
  • Willing and able to provide informed consent.

排除标准

  • - None; all pediatric residents meeting inclusion criteria are eligible.

研究组 & 干预措施

Choice

Experimental

Participants randomized to the Choice arm will select their preferred duration of the Wakeful digital mindfulness program (3, 5, or 7 weeks) prior to beginning the intervention. After making their selection, participants will complete one module per week in sequential order based on their chosen program length. Each module includes didactic content, guided mindfulness practices, and optional reflection activities. Participants may also engage in optional independent meditation practices throughout the study period. This arm is designed to evaluate whether allowing participants to choose their intervention duration influences engagement, adherence, and acceptability of the program.

干预措施: Wakeful Digital Mindfulness Program (Behavioral)

No Choice

Experimental

Participants randomized to the No-Choice arm are assigned a Wakeful digital mindfulness program duration (3, 5, or 7 weeks) without input. Assignment is matched to participants in the Choice arm to balance program lengths across groups. Participants complete one module per week in sequential order according to their assigned program length. Each module includes didactic content, guided mindfulness practices, and optional reflection activities. Optional independent meditation practice is also available. This arm is designed to assess engagement, adherence, and acceptability under a structured format without participant-selected program duration.

干预措施: Wakeful Digital Mindfulness Program (Behavioral)

结局指标

主要结局

Engagement and completion of Wakeful program modules

时间窗: Baseline and immediately post-intervention (3, 5, or 7 weeks depending on program length)

The primary outcome measures participant engagement with the Wakeful digital mindfulness program, including (1) the number of program modules completed, (2) frequency and duration of platform use, (3) frequency of independent meditation practice, (4) perceived usability and relevance, and (5) overall satisfaction and dropout rates. All measures are collected via de-identified platform usage data and post-intervention surveys to assess acceptability and adherence.

次要结局

  • Changes in mindfulness, self-compassion, and compassion for others(Baseline and immediately post-intervention (3, 5, or 7 weeks depending on program length))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason Tsichlis

Pediatric Hospital Medicine Fellow

Northwestern University

研究点 (1)

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