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.

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.

Inclusion Criteria:

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

Exclusion Criteria:

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