Mental Health IssueNCT05736445
Evaluating Student Wellness Using a Blended Approach of the Roadmap mHealth App Plus Wellness Coaching
An observational study of Mental Health Issue, run by University of Michigan at 1 site in United States.
Trial summary
In this pilot study, the investigators plan to examine how the combination of wellness coaching and a mobile health app that promotes positive psychology activities can improve the overall well-being of college students. 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?
- Wellness coaching plus app use
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2023to 15 Jun 2023
- Phase
- Observational
- 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
Study population: Students enrolled at the University of Michigan
Who may be able to join
- University of Michigan students aged 18 years or older.
- Students must either be coming to campus for the academic year or taking classes online for the academic year.
- For those completing school online, must be able to provide a mailing address within the United States where they can receive study tools and be mailed study materials
- Possess a smartphone (Apple or Android).
- Ability to understand and demonstrate willingness to remotely sign a written informed consent.
Who cannot join
- People who are not enrolled in classes at the University of Michigan for the Winter 2023 term.
- Unwilling or unable to comply with the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
In this pilot study, the investigators plan to examine how the combination of wellness coaching and a mobile health app that promotes positive psychology activities can improve the overall well-being of college students. With these tools, the investigators hope to better understand the relationship between digital intervention and coaching and determine how it may improve the mental health of students. The study team also hopes to investigate how mental health can impact academic performance.
Read the detailed description
Students seeking wellness coaching will have the option to participate in this study. The study will ask participants 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
- Allow the study team to access academic records (optional)
The investigators plan to evaluate the app + coaching influence on mental health outcomes and to determine what can be learned to improve its design for a future, full-scale study, if there is evidence of adoption and sustainability from this pilot study.
- Conditions
- Mental Health Issue
- Being tested
- Wellness coaching plus app use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness coaching plus app useBehavioural
Participants will participate in wellness coaching and interact with apps on their smartphones
| Study group | Role | What they receive |
|---|---|---|
| Students at the University of Michigan | Students enrolled in the Winter 2023 academic semester at the University of Michigan Receives: Behavioral: Wellness coaching plus app use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wellness Coaching + App Use
To assess the primary endpoint, the investigators will evaluate participants' opinions about the uptake of Roadmap + Wellness Coaching through semi-structured qualitative interviews. The investigators will ask questions related to the feasibility and acceptability of the: 1) Roadmap 2.0 app; 2) Fitbit device; 3) completing assessments (through the app); and 4) wellness coaching. The investigators expect the net favorability (agree + totally agree) of all four components will be >50% based on answering questions on a scale of totally disagree, disagree, neutral, agree, and totally agree to be considered feasible and acceptable to participate in.
Measured: 9 months
Secondary outcomes (1)
Survey Completion
Assess survey completion rate, estimating 50% of participants will complete the surveys at all four time points
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start8 Jan 2023
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- 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
- NCT05736445
- Sponsor's protocol ID
- HUM00223936
- Status last verified
- Sep 2023
- First submitted
- 26 Jan 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Student Wellness Using a Blended Approach of the Roadmap mHealth App Plus Wellness Coaching
- ClinicalTrials.gov ID
- NCT05736445
- Acronym / sponsor ID
- HUM00223936
- Conditions
- Mental Health Issue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 21 Feb 2023 (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 pilot study, the investigators plan to examine how the combination of wellness coaching and a mobile health app that promotes positive psychology activities can improve the overall well-being of college students. With these tools, the investigators hope to better understand the relationship between digital intervention and coaching and determine how it may improve the mental health of students. The study team also hopes to investigate how mental health can impact academic performance.
Detailed description
Students seeking wellness coaching will have the option to participate in this study. The study will ask participants 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
- Allow the study team to access academic records (optional)
The investigators plan to evaluate the app + coaching influence on mental health outcomes and to determine what can be learned to improve its design for a future, full-scale study, if there is evidence of adoption and sustainability from this pilot study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Students at the University of Michigan | – | Behavioral: Wellness coaching plus app useStudents enrolled in the Winter 2023 academic semester at the University of Michigan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Students enrolled at the University of Michigan
Key inclusion criteria (5 listed)
- University of Michigan students aged 18 years or older.
- Students must either be coming to campus for the academic year or taking classes online for the academic year.
- For those completing school online, must be able to provide a mailing address within the United States where they can receive study tools and be mailed study materials
- Possess a smartphone (Apple or Android).
- Ability to understand and demonstrate willingness to remotely sign a written informed consent.
Key exclusion criteria (2 listed)
- People who are not enrolled in classes at the University of Michigan for the Winter 2023 term.
- 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 |
|---|---|---|
| Wellness coaching plus app useParticipants will participate in wellness coaching and interact with apps on their smartphones | Behavioural | Students at the University of Michigan |
Primary outcome
Wellness Coaching + App Use
Time frame: 9 months
To assess the primary endpoint, the investigators will evaluate participants' opinions about the uptake of Roadmap + Wellness Coaching through semi-structured qualitative interviews. The investigators will ask questions related to the feasibility and acceptability of the: 1) Roadmap 2.0 app; 2) Fitbit device; 3) completing assessments (through the app); and 4) wellness coaching. The investigators expect the net favorability (agree + totally agree) of all four components will be >50% based on answering questions on a scale of totally disagree, disagree, neutral, agree, and totally agree to be considered feasible and acceptable to participate in.
1 secondary outcome
Survey Completion
Time frame: 7 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 21 Sep 2023.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health Issue, run by University of Michigan at 1 site 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Wellness Coaching + App Use (time frame: 9 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 21 Sep 2023.