Clinical trial Recruiting at 1 site Interventional

On Track for Wellness: a stepped-wedge program to boost sleep and activity in first-episode psychosis

Official title: On Track for Wellness: Stepped-wedge Cluster Randomized Trial of a Fitbit Enhanced Health Intervention for Early Onset Psychosis

Run by University of Illinois Chicago · NCT07387705 · Data updated 2026-11-12

This program tests whether using Fitbit trackers, health education, and goal setting helps people with first-episode psychosis sleep better and move more.

Quick facts

Study typeInterventional
SexAll
Enrollment365 (estimated)
SponsorUniversity of Illinois Chicago
Academic / other
Locations1 site (Chicago, Illinois)
StatusRecruiting
StartedSeptember 1, 2026
Main results expectedSeptember 1, 2030
Study endsDecember 1, 2030
Registry record updatedOctober 27, 2026
Trial IDNCT07387705 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Programs that provide first-episode psychosis services funded by the Illinois Department of Human Services can participate, with enrollment at the program level.

Probably not a fit

Individuals in programs not adopting OTW or in settings outside Illinois DHS-funded early psychosis services may not experience benefits from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial tests the On Track for Wellness (OTW) program across Illinois’ early psychosis programs using a stepped-wedge cluster design. Phase 1 collects qualitative feedback from staff and clients in two programs, while phase 2 trains remaining programs and uses administrative data and Fitbit information to measure changes over three years. The study emphasizes real-world implementation within state-funded services and relies on program-level enrollment rather than individual enrollment. Outcomes focus on sleep hygiene and physical activity, informing whether OTW can be scaled within state systems. Lead oversight is by the University of Illinois Chicago, with Illinois DHS DBHR guiding deployment.

Why it matters

Potential benefit: If successful, OTW could improve sleep and activity levels for people with early psychosis, potentially supporting better overall health and functioning.

How similar studies have gone: Prior similar efforts using activity tracking and health education have shown promise in behavior change, though this specific stepped-wedge, program-level design is relatively novel in this setting.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria: Client at First Episode psychosis program funded by the Illinois Department of Human Services. Enrollment is at program level; no individual subject enrollment.

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Exclusion Criteria: not a client at a First Episode psychosis program funded by the Illinois Department of Human Services. Enrollment is at program level; no individual subject enrollment.

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Where it's running

  • University of Illinois Chicago
    Chicago, Illinois, United States
    Recruiting

Study contacts

  • Principal investigator: Judith A Cook, Ph.D — University of Illinois Chicago
  • Study coordinator: Judith A Cook, Ph.D.
  • Email: jcook@uic.edu
  • Phone: 312-355-3921

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.