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Student Wellness 2.0

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University of Michigan

Status

Completed

Conditions

Mental Health Issue

Treatments

Behavioral: Mobile health app with positive psychological activities

Study type

Interventional

Funder types

Other

Identifiers

NCT06804213
HUM00257823

Details and patient eligibility

About

In this randomized controlled study, investigators plan to assess the impact of a mobile health app with positive psychological combined with wellness coaching on college student mental health outcomes. The study aims to differentiate the effectiveness of combining mobile health and wellness coaching compared to wellness coaching on its own. The goal is to improve our understanding of the optimal combination of traditional in-person and digital interventions on diverse student populations, as well as better understand the causal impact of the mobile health app on well-being.

Full description

Study participants will be asked to:

  1. Complete as many sessions of individual wellness coaching as they see fit
  2. Install and interact with the Fitbit and Roadmap 2.0 apps on their smartphone
  3. Complete longitudinal surveys at baseline, month 1, month 2, and end of study
  4. Complete an exit interview at the end of the study

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Must be at least 18 years old.
  2. Students must be either enrolled at the University of Michigan OR in the STEER transition program.
  3. Potential subjects must be able to provide a mailing address within the United States where they can receive study tools and be mailed study materials (e.g., Fitbit, compensation).
  4. Possess a smartphone (Apple or Android).
  5. Ability to understand and demonstrate willingness to remotely sign a written informed consent document

Exclusion criteria

  1. People who are not enrolled in classes at the University of Michigan OR people who are not members of the STEER organization.
  2. Unwilling or unable to comply with the study procedures

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

83 participants in 2 patient groups

Wellness coaching plus mobile health app (positive activities)
Experimental group
Description:
Participants will participate in wellness coaching and receive a wearable device, and they will be assigned to use the mobile health app with positive psychological activities installed. Additionally, participants can view their daily step count and number of hours of sleep in the mobile health app.
Treatment:
Behavioral: Mobile health app with positive psychological activities
Wellness coaching plus limited mobile health app (no positive activities)
No Intervention group
Description:
Participants will participate in wellness coaching and receive a wearable device, but will be assigned to use the mobile health app WITHOUT positive psychological activities installed. Participants can only view their daily step count and number of hours of sleep in the mobile health app.

Trial contacts and locations

2

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Central trial contact

Sung Won Choi, MD, MS; Tracey Churay, MS

Data sourced from clinicaltrials.gov

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