Choice and Autonomy in Learning Mindfulness for Pediatric Residents

NCT07542769 | Not Yet Recruiting

• 2 other identifiers: STU00224541-MOD0001GR002591-01
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Program Engagement; Treatment Adherence and Compliance; Mindfulness; Self-Compassion; Physician Burnout; Psychological Well-Being; Meditation; Meditation Training

Keywords

Mindfulness; Meditation; Digital Health Intervention; Internet-Based Intervention; Physician Well-Being; Graduate Medical Education; Pediatric Residency; Treatment Adherence and Compliance; Patient Acceptance of Health Care; Program Engagement; User Engagement; Pilot Projects; Self-Compassion; Compassion

Outcome Measures

Primary Outcomes (1)

• Engagement and completion of Wakeful program modules

  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 Outcomes (1)

• Changes in mindfulness, self-compassion, and compassion for others

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

Study Arms (2)

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.

Behavioral: Wakeful Digital Mindfulness Program

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.

Behavioral: Wakeful Digital Mindfulness Program

Interventions

Wakeful Digital Mindfulness Program BEHAVIORAL

Wakeful digital mindfulness program: an asynchronous, web-based course with guided meditations, didactic content, and optional reflective exercises.

Choice; No Choice

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 10.1177/27536130241290771. eCollection 2024 Jan-Dec.

  PMID: 39381495 BACKGROUND

MeSH Terms

Conditions

Treatment Adherence and Compliance; Psychological Well-Being; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Personal Satisfaction

Central Study Contacts

Jason T Tsichlis, MD, MS

CONTACT

312-227-4000; jtsichlis@luriechildrens.org

Gabrielle Osher

CONTACT

312-227-4000; gabrielle.osher@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Hospital Medicine Fellow

Model Details: This study uses a parallel assignment design in which participants are randomized to one of two groups: a Choice arm or a No-Choice arm. Participants in the Choice arm select their preferred duration of a digital mindfulness program (3, 5, or 7 weeks), while participants in the No-Choice arm are assigned a program duration using a matched randomization approach to ensure balanced distribution across durations. Participants remain in their assigned group for the duration of the study and complete one program format only. Outcomes related to engagement, adherence, and acceptability are compared between groups.

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share