Recruiting

Wakeful

Sponsor:

Northwestern University

Code:

NCT07542769

Conditions

Program Engagement

Treatment Adherence and Compliance

Mindfulness

Self-Compassion

Physician Burnout

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Wakeful Digital Mindfulness Program

Study Details

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

Study ID

NCT07542769

Start date

Apr 13, 2026

Status verified date

May, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Wakeful Digital Mindfulness Program

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

Primary outcome measure

  • Engagement and completion of Wakeful program modules [ Time Frame: Baseline and immediately post-intervention (3, 5, or 7 weeks depending on program length) ]

Central Contacts and Locations

Locations

McGaw Medical Center

Recruiting

Chicago, Illinois, United States, 60622

Contacts

Principal Investigator:

Jason Tsichlis, MD, MS

More Information

Sponsor

Northwestern University

Last update posted

May 26, 2026

Last verified

May, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-05-26.