Choice and Autonomy in Learning Mindfulness for Pediatric Residents (CALM-PR)

May 21, 2026 updated by: Jason Tsichlis, Northwestern University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60622
        • Recruiting
        • McGaw Medical Center
        • Contact:
        • Principal Investigator:
          • Jason Tsichlis, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Choice
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.
Behavioral: Wakeful Digital Mindfulness Program
Wakeful digital mindfulness program: an asynchronous, web-based course with guided meditations, didactic content, and optional reflective exercises.
Experimental: No Choice
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.
Behavioral: Wakeful Digital Mindfulness Program
Wakeful digital mindfulness program: an asynchronous, web-based course with guided meditations, didactic content, and optional reflective exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement and completion of Wakeful program modules
Time Frame: 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.
Baseline and immediately post-intervention (3, 5, or 7 weeks depending on program length)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in mindfulness, self-compassion, and compassion for others
Time Frame: Baseline and immediately post-intervention (3, 5, or 7 weeks depending on program length)
Exploratory outcomes assess trends in psychological constructs following the Wakeful digital mindfulness program. Measures include mindfulness using the PROMIS Global Mindfulness Measure, self-compassion using the Neff Self-Compassion Scale, and compassion for others using the Neff Compassion Scale. These surveys are completed at baseline and post-intervention. The study is not powered for statistical comparisons; analyses are descriptive to guide future intervention design.
Baseline and immediately post-intervention (3, 5, or 7 weeks depending on program length)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00224541-MOD0001
  • GR002591-01 (Other Grant/Funding Number: Osher Center for Integrative Health at Northwestern University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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