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临床试验/NCT06804213
NCT06804213已完成不适用

A Randomized Controlled Study Evaluating Student Wellness Using the Roadmap mHealth App and Wellness Coaching

University of Michigan4 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2025年1月27日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
4
主要终点
Evaluate the effectiveness of Roadmap 2.0 plus wellness coaching on college student mental health

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be at least 18 years old.
  • Students must be either enrolled at the University of Michigan OR in the STEER transition program.
  • 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).
  • Possess a smartphone (Apple or Android).
  • Ability to understand and demonstrate willingness to remotely sign a written informed consent document

排除标准

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

结局指标

主要结局

Evaluate the effectiveness of Roadmap 2.0 plus wellness coaching on college student mental health

时间窗: From enrollment to the exit survey at 4 months

Evaluate the difference between the intervention (Roadmap 2.0 + wellness coaching) arm and the control (limited Roadmap 2.0 + wellness coaching) arm by measuring the effectiveness of Roadmap 2.0 when coupled with wellness coaching. Participants will complete validated quality-of-life surveys, which measure subject-reported outcomes related to mental health.

次要结局

  • Survey completion(From enrollment to the exit survey at 4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sung Won Choi

Edith S Briskin and Shirley K Schlafer Foundation Research Professor of Pediatrics and Associate Professor of Pediatrics and Communicable Diseases

University of Michigan

研究点 (4)

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