Depressive SymptomsNCT06583096
College Student Stress: Transitions Over Time
A study testing Surveys, Supportive Text messages and Personalized Feedback (PF) Report in people with Depressive Symptoms, run by University of Michigan at 1 site in United States.
Trial summary
This research study is being conducted to better understand how college students develop and cope with stress and to identify opportunities to help students notice and respond to stress early before symptoms contribute to significant negative consequences. This project will be completed in two parts. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Surveys, Supportive Text messages and Personalized Feedback (PF) Report
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 27 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First-year college students that are full-time or part-time students enrolled at the University of Michigan, Ann Arbor or Flint campuses
- Mild-to-moderate depressive symptoms, and are not receiving professional mental health services will be eligible
Who cannot join
- Under the age of 17
- Currently be receiving mental health therapy/counseling from a healthcare professional
- Experiencing minimal depressive symptoms (defined in protocol)
- Experiencing moderately severe to severe depressive symptoms (defined in protocol)
Trial locations and contacts
1 site in 1 country.
About this study
This research study is being conducted to better understand how college students develop and cope with stress and to identify opportunities to help students notice and respond to stress early before symptoms contribute to significant negative consequences.
This project will be completed in two parts. In the first part (not a trial) participants will be asked to complete a screening survey to determine eligibility. Eligible participants (i.e., those with mild-to-moderate depressive symptoms and not receiving mental health care) will continue into the clinical trial portion (part two). There were 120 students in the clinical trial phase of the study, where 30 were randomly assigned to "assessment only" and 90 to the "intervention" condition.
- Conditions
- Depressive Symptoms
- Being tested
- Surveys, Supportive Text messages, Personalized Feedback (PF) Report
- Keywords
- First-year college student, Surveys, Supportive text messages, Stress, Personalized feedback
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysBehavioural
Participants (in both arms) will complete surveys once per week and participants in the intervention arm will also complete additional 1-minute surveys daily. Study participation will be completed at the conclusion of the final follow-up survey administered 6-weeks after study enrollment.
Supportive Text messagesBehavioural
Text messages will be sent Mondays-Sunday if participants are randomized to receive them in a given week, with a daily 50:50 send/no-send randomization. A bank of 25 text messages will be used for the study, providing tips/strategies across a range of topics, including managing time and academic stressors, recommendations for self-care and mood management, and messages geared towards fostering social connections and support. Some messages will contain links to videos, websites, or articles for more information on a topic.
Personalized Feedback (PF) ReportBehavioural
For individuals that are randomized to receive a Personalized Feedback Report, the study team will send participants a text on a Monday with the feedback from the prior survey (baseline survey in the first week, weekly survey in the next five weeks). There will be graphs for depression, anxiety, stress, and flourishing.
| Study group | Role | What they receive |
|---|---|---|
| Assessment Only | Other | Weekly surveys only. Receives: Behavioral: Surveys |
| Intervention - surveys, text messages, and feedback reports | Experimental | Participants in the intervention arm will be randomized to receive (or not receive) text messages in a given week, with a daily randomization to receive (or not receive) a text message if randomized to receive text messages that week.
Additionally, participants will be randomized each week to receive (or not receive) personalized feedback reports. Receives: Behavioral: Surveys; Behavioral: Supportive Text messages; Behavioral: Personalized Feedback (PF) Report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eligible Participants Who Agreed to Participate in the Trial
Of the individuals meeting eligibility criteria (i.e., mild-to-moderate depressive symptoms, no current mental health service utilization) from the initial screen, what percentage agreed to be enrolled and randomized into the clinical trial.
Measured: Up to 10 days after screening survey
Percentage of Participants Who Completed Follow-ups
Weekly ten-minute surveys assessing mental health symptoms, stress, and adaptive functioning were sent to participants. Results reflect the number of participants who completed their survey each week.
Measured: Baseline up to six-week follow-up
Percentage of Participants That Remain Active (i.e. do Not Request to Stop Messages) on the Text-message Group
Results reflect the participants who remained active during the full trial in the intervention group.
Measured: Baseline up to six-week follow-up
Number of Withdrawals
Results reflect participants who requested to withdraw from the trial.
Measured: Baseline up to six-week follow-up
Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports
As part of the intervention arm, participants were randomized each week to receive or not receive personalized feedback reports. Reports had graphical explanations of the participant's responses to the survey questions. The data values reported reflect the number of participants who viewed feedback reports, while the Number Analyzed for each Row reflects the number of participants who were sent a personalized feedback report that week.
Measured: Baseline up to six-week follow-up
Percent of Participants (in the Intervention Arm) That Viewed a Personalized Feedback Report at Least Once
As part of the intervention, some participants in the intervention arm were randomly sent feedback reports. Reports had graphical explanations of the participant's response to the survey questions. All participants in the intervention arm were sent at least one feedback report during the course of the trial. Results reflect the number of participants who viewed at least one report.
Measured: Baseline up to six-week follow-up
Participant Self-reported Satisfaction With the Intervention Components - Assessment-only
Participants in the "Assessment Only" arm who completed the 6-week follow-up survey responded to an 8-question survey regarding their satisfaction with the study. Each question was on a scale of 1 to 7 (1-Strongly disagree, 4 Neither agree nor disagree, 7-Strongly Agree). A higher score indicated more satisfaction with the study. Results reflect the average participant scores for each question.
Measured: Six-week follow-up
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
Participants in the "Intervention" arm who completed the 6-week follow-up survey responded to an 18-question survey regarding their satisfaction with the intervention. Each question was on a scale of 1 to 7 (1-Strongly disagree, 4 Neither agree nor disagree, 7-Strongly Agree). A higher score indicated more satisfaction. Results reflect the average participant scores for each question.
Measured: Six-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Oct 2024
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depressive SymptomsStudies 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
- Model description
- After initial survey (screening) is received, participants that are eligible for the trial and complete the baseline assessments will be assigned (3:1) to the "Assessment Only" (n = 30) or the "Intervention" (n=90) condition". The intervention arm contains two components: personalized feedback reports and supportive text messages. Each week participants are randomized, with a 2:1 probability to receive (versus not receive) a personalized feedback report, and a 2:1 probability to receive (versus not receive) supportive text messages during the week. For those randomized to receive text messages in a given week, there is a daily 50:50 randomization to receive (or not receive) a text message.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Adam Horwitz, University of Michigan
- Investigators
- Adam Horwitz, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583096
- Sponsor's protocol ID
- HUM00257547
- Other IDs
- K23MH131761
- Status last verified
- Nov 2025
- First submitted
- 27 Aug 2024
- Last updated
- 4 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be shared upon request following publication of primary results.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- College Student Stress: Transitions Over Time
- ClinicalTrials.gov ID
- NCT06583096
- Acronym / sponsor ID
- HUM00257547
- Conditions
- Depressive Symptoms
- Keywords
- First-year college student, Surveys, Supportive text messages, Stress, Personalized feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Posted 4 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being conducted to better understand how college students develop and cope with stress and to identify opportunities to help students notice and respond to stress early before symptoms contribute to significant negative consequences.
This project will be completed in two parts. In the first part (not a trial) participants will be asked to complete a screening survey to determine eligibility. Eligible participants (i.e., those with mild-to-moderate depressive symptoms and not receiving mental health care) will continue into the clinical trial portion (part two). There were 120 students in the clinical trial phase of the study, where 30 were randomly assigned to "assessment only" and 90 to the "intervention" condition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After initial survey (screening) is received, participants that are eligible for the trial and complete the baseline assessments will be assigned (3:1) to the "Assessment Only" (n = 30) or the "Intervention" (n=90) condition". The intervention arm contains two components: personalized feedback reports and supportive text messages. Each week participants are randomized, with a 2:1 probability to receive (versus not receive) a personalized feedback report, and a 2:1 probability to receive (versus not receive) supportive text messages during the week. For those randomized to receive text messages in a given week, there is a daily 50:50 randomization to receive (or not receive) a text message.
| Arm | Type | Receives |
|---|---|---|
| Assessment Only | Other | Behavioral: SurveysWeekly surveys only. |
| Intervention - surveys, text messages, and feedback reports | Experimental | Behavioral: Surveys, Behavioral: Supportive Text messages, Behavioral: Personalized Feedback (PF) ReportParticipants in the intervention arm will be randomized to receive (or not receive) text messages in a given week, with a daily randomization to receive (or not receive) a text message if randomized to receive text messages that week. Additionally, participants will be randomized each week to receive (or not receive) personalized feedback reports. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- First-year college students that are full-time or part-time students enrolled at the University of Michigan, Ann Arbor or Flint campuses
- Mild-to-moderate depressive symptoms, and are not receiving professional mental health services will be eligible
Key exclusion criteria (4 listed)
- Under the age of 17
- Currently be receiving mental health therapy/counseling from a healthcare professional
- Experiencing minimal depressive symptoms (defined in protocol)
- Experiencing moderately severe to severe depressive symptoms (defined in protocol)
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 |
|---|---|---|
| SurveysParticipants (in both arms) will complete surveys once per week and participants in the intervention arm will also complete additional 1-minute surveys daily. Study participation will be completed at the conclusion of the final follow-up survey administered 6-weeks after study enrollment. | Behavioural | Assessment Only, Intervention - surveys, text messages, and feedback reports |
| Supportive Text messagesText messages will be sent Mondays-Sunday if participants are randomized to receive them in a given week, with a daily 50:50 send/no-send randomization. A bank of 25 text messages will be used for the study, providing tips/strategies across a range of topics, including managing time and academic stressors, recommendations for self-care and mood management, and messages geared towards fostering social connections and support. Some messages will contain links to videos, websites, or articles for more information on a topic. | Behavioural | Intervention - surveys, text messages, and feedback reports |
| Personalized Feedback (PF) ReportFor individuals that are randomized to receive a Personalized Feedback Report, the study team will send participants a text on a Monday with the feedback from the prior survey (baseline survey in the first week, weekly survey in the next five weeks). There will be graphs for depression, anxiety, stress, and flourishing. | Behavioural | Intervention - surveys, text messages, and feedback reports |
Primary outcome
Percentage of Eligible Participants Who Agreed to Participate in the Trial
Time frame: Up to 10 days after screening survey
Of the individuals meeting eligibility criteria (i.e., mild-to-moderate depressive symptoms, no current mental health service utilization) from the initial screen, what percentage agreed to be enrolled and randomized into the clinical trial.
Percentage of Participants Who Completed Follow-ups
Time frame: Baseline up to six-week follow-up
Weekly ten-minute surveys assessing mental health symptoms, stress, and adaptive functioning were sent to participants. Results reflect the number of participants who completed their survey each week.
Percentage of Participants That Remain Active (i.e. do Not Request to Stop Messages) on the Text-message Group
Time frame: Baseline up to six-week follow-up
Results reflect the participants who remained active during the full trial in the intervention group.
Number of Withdrawals
Time frame: Baseline up to six-week follow-up
Results reflect participants who requested to withdraw from the trial.
Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports
Time frame: Baseline up to six-week follow-up
As part of the intervention arm, participants were randomized each week to receive or not receive personalized feedback reports. Reports had graphical explanations of the participant's responses to the survey questions. The data values reported reflect the number of participants who viewed feedback reports, while the Number Analyzed for each Row reflects the number of participants who were sent a personalized feedback report that week.
Percent of Participants (in the Intervention Arm) That Viewed a Personalized Feedback Report at Least Once
Time frame: Baseline up to six-week follow-up
As part of the intervention, some participants in the intervention arm were randomly sent feedback reports. Reports had graphical explanations of the participant's response to the survey questions. All participants in the intervention arm were sent at least one feedback report during the course of the trial. Results reflect the number of participants who viewed at least one report.
Participant Self-reported Satisfaction With the Intervention Components - Assessment-only
Time frame: Six-week follow-up
Participants in the "Assessment Only" arm who completed the 6-week follow-up survey responded to an 8-question survey regarding their satisfaction with the study. Each question was on a scale of 1 to 7 (1-Strongly disagree, 4 Neither agree nor disagree, 7-Strongly Agree). A higher score indicated more satisfaction with the study. Results reflect the average participant scores for each question.
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
Time frame: Six-week follow-up
Participants in the "Intervention" arm who completed the 6-week follow-up survey responded to an 18-question survey regarding their satisfaction with the intervention. Each question was on a scale of 1 to 7 (1-Strongly disagree, 4 Neither agree nor disagree, 7-Strongly Agree). A higher score indicated more satisfaction. Results reflect the average participant scores for each question.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified IPD will be shared upon request following publication of primary results.
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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.
Adam Horwitz, Ph.D. 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?
A study testing Surveys, Supportive Text messages and Personalized Feedback (PF) Report in people with Depressive Symptoms, 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 2 inclusion and 4 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 4 Dec 2025. 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?
Yes. Results are posted in the registry (first posted 4 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Eligible Participants Who Agreed to Participate in the Trial (time frame: Up to 10 days after screening survey). The study lists 8 primary outcomes in all. 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 4 Dec 2025.