Using PROMIS Methodology to Create Self-Report Measures of Mindfulness and Related Concepts.
David Victorson, Natalia E Morone, Paul A Pilkonis...
https://pubmed.ncbi.nlm.nih.gov/39381495/Actively Recruiting
Led by Northwestern University · Updated on 2026-05-26
42
Participants Needed
1
Research Sites
17 weeks
Total Duration
This research aims to evaluate a flexible, online mindfulness program called Wakeful designed for pediatric residents who often experience high levels of stress during medical training. The study addresses the limitations of traditional mindfulness programs that are usually in-person or have fixed schedules, which may not suit the busy and varied schedules of medical trainees. The goal is to understand if allowing participants to choose the length of their mindfulness program improves engagement, satisfaction, and completion rates. Participants will be randomly assigned to one of two groups one group selects the duration of their Wakeful mindfulness program 3, 5, or 7 weeks, while the other group is assigned a program length without choice. Both groups complete one module per week, each lasting 45 to 60 minutes, including didactic content, guided meditation, and optional reflection. The program is web-based and can be accessed remotely via computer, tablet, or smartphone. Optional independent mindfulness practice is encouraged throughout the study. During the study, participants complete questionnaires before and after the intervention, and some may take part in optional debrief interviews. Researchers will collect usage data from the platform to measure engagement, program completion, frequency of meditation practice, user satisfaction, and dropout rates. Secondary outcomes include exploring changes in mindfulness and compassion, though the study is not designed to assess clinical mental health improvements. Participation lasts according to the chosen or assigned program length, and all data is handled confidentially.
CONDITIONS
Choice and Autonomy in Learning Mindfulness for Pediatric Residents
J
Jason T Tsichlis, MD, MS
G
Gabrielle Osher
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Northwestern University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Digital Mindfulness: Participant Chooses Module Order | Digital Mindfulness: Assigned Module Order |
|---|---|---|
| What is it? | A digital mindfulness course where residents can select the sequence of modules. Content includes guided meditations and optional reflective exercises. | A digital mindfulness course where residents are assigned a fixed sequence of modules. The content and platform are the same as in the choice arm. |
| Role in the trial | Investigational arm testing if offering module-order choice affects program engagement, adherence, or participant satisfaction. | Comparator arm in which module order is assigned without participant choice, to assess effects on program engagement and outcomes. |
| Primary use | Aims to improve mindfulness, self-compassion, and psychological well-being among pediatric residents by allowing choice in module order. | Aims to improve mindfulness, self-compassion, and psychological well-being among pediatric residents using assigned module order. |
| How it is given or performed | The course is delivered online, asynchronously, with participants choosing the order in which they complete modules. | The course is delivered online, asynchronously, with participants required to complete modules in a fixed, assigned order. |
| Evidence status | No results for the choice approach in this precise format are available yet, though previous randomized trials of mindfulness for resident physicians show benefits in distress reduction and well-being. | No results for the assigned-order approach in this specific program are available yet, but evidence from randomized trials indicates structured mindfulness training can reduce distress among resident physicians. |
| Important limitations | Because results are not yet available for the choice-based program, it is unknown if allowing choice will improve engagement or well-being compared to a fixed sequence. Evidence for digital mindfulness in medical residents is promising but limited by sample sizes and varied program types. | No outcome data are yet available for the assigned-order approach. Existing research suggests variable engagement, no consensus on optimal structure, and few large-scale studies in US pediatric residents. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for consent and baseline questionnaire
Duration - 3, 5, or 7 weeks depending on assigned or selected program length
Participants complete the Wakeful digital mindfulness program remotely, engaging with one module per week. Each module includes guided meditations, didactic content, and optional reflection activities. Participants may also practice mindfulness independently outside of the modules.
Weekly remote sessions for 3, 5, or 7 weeks
Duration - 2 to 4 weeks
After completing the program, participants complete a post-intervention questionnaire and may participate in an optional in-person debrief interview to discuss their experience and engagement with the program.
1 post-intervention questionnaire and optional 1 in-person debrief interview
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/34369618/Northwestern University
Lead Sponsor