Mental Health IssueNCT06804213
Student Wellness 2.0
A study testing Mobile health app with positive psychological activities in people with Mental Health Issue, run by University of Michigan at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Mobile health app with positive psychological activities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jan 2025to 29 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
STEER for Student Athletes
Port Chester, New York, 10573
About this study
Official title: A Randomized Controlled Study Evaluating Student Wellness Using the Roadmap mHealth App and Wellness Coaching
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.
Read the detailed description
Study participants will be asked to:
- Complete as many sessions of individual wellness coaching as they see fit
- Install and interact with the Fitbit and Roadmap 2.0 apps on their smartphone
- Complete longitudinal surveys at baseline, month 1, month 2, and end of study
- Complete an exit interview at the end of the study
- Conditions
- Mental Health Issue
- Being tested
- Mobile health app with positive psychological activities
- Keywords
- mobile health, wearable sensors, college students, wellness coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health app with positive psychological activitiesBehavioural
Mobile health app with step tracking, sleep tracking, and positive psychological activities
| Study group | Role | What they receive |
|---|---|---|
| Wellness coaching plus mobile health app (positive activities) | Experimental | 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. Receives: Behavioral: Mobile health app with positive psychological activities |
| Wellness coaching plus limited mobile health app (no positive activities) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of Roadmap 2.0 plus wellness coaching on college student mental health
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.
Measured: From enrollment to the exit survey at 4 months
Secondary outcomes (1)
Survey completion
Assess survey completion rate, estimating at least 50% of participants will complete the surveys at all four time points.
Measured: From enrollment to the exit survey at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start27 Jan 2025
- Primary completion29 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- STEER for Student Athletes
- Responsible party
- Principal investigator, Sung Won Choi, University of Michigan
- Investigators
- Sung Won Choi, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804213
- Sponsor's protocol ID
- HUM00257823
- Status last verified
- Jun 2025
- First submitted
- 28 Jan 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study Evaluating Student Wellness Using the Roadmap mHealth App and Wellness Coaching
- ClinicalTrials.gov ID
- NCT06804213
- Acronym / sponsor ID
- HUM00257823
- Conditions
- Mental Health Issue
- Keywords
- mobile health, wearable sensors, college students, wellness coaching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- STEER for Student Athletes
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study participants will be asked to:
- Complete as many sessions of individual wellness coaching as they see fit
- Install and interact with the Fitbit and Roadmap 2.0 apps on their smartphone
- Complete longitudinal surveys at baseline, month 1, month 2, and end of study
- Complete an exit interview at the end of the study
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wellness coaching plus mobile health app (positive activities) | Experimental | Behavioral: Mobile health app with positive psychological activitiesParticipants 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. |
| Wellness coaching plus limited mobile health app (no positive activities) | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile health app with positive psychological activitiesMobile health app with step tracking, sleep tracking, and positive psychological activities | Behavioural | Wellness coaching plus mobile health app (positive activities) |
Primary outcome
Evaluate the effectiveness of Roadmap 2.0 plus wellness coaching on college student mental health
Time frame: 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.
1 secondary outcome
Survey completion
Time frame: From enrollment to the exit survey at 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Won Choi, MD, MS principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health app with positive psychological activities in people with Mental Health Issue, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of Roadmap 2.0 plus wellness coaching on college student mental health (time frame: From enrollment to the exit survey at 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.