NCT06583096

College Student Stress: Transitions Over Time

Completed NA Results posted Last updated 4 December 2025

What this trial tests

NA trial testing Surveys in Depressive Symptoms in 120 participants. Completed in 27 November 2024.

Timeline

1 October 2024

Primary endpoint
27 November 2024

27 November 2024

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	120
Start date	1 October 2024
Primary completion	27 November 2024
Estimated completion	27 November 2024
Sites	1 location across United States

Drugs / interventions tested

• Surveys
• Supportive Text messages
• Personalized Feedback (PF) Report

Conditions studied

• Depressive Symptoms — all drugs for Depressive Symptoms →

Sponsor

University of Michigan

Who can join

17 and older, any sex, with Depressive Symptoms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Eligible Participants Who Agreed to Participate in the Trial Primary · 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.

Group	Value	95% CI
Eligible Participants	120

Percentage of Participants Who Completed Follow-ups Primary · 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.

Week 1

Group	Value	95% CI
Assessment Only	23
Intervention	81

Week 2

Group	Value	95% CI
Assessment Only	23
Intervention	80

Week 3

Group	Value	95% CI
Assessment Only	24
Intervention	79

Week 4

Group	Value	95% CI
Assessment Only	25
Intervention	78

Week 5

Group	Value	95% CI
Assessment Only	24
Intervention	76

Week 6

Group	Value	95% CI
Assessment Only	26
Intervention	78

Percentage of Participants That Remain Active (i.e. do Not Request to Stop Messages) on the Text-message Group Primary · Baseline up to six-week follow-up

Results reflect the participants who remained active during the full trial in the intervention group.

Group	Value	95% CI
Intervention	88

Number of Withdrawals Primary · Baseline up to six-week follow-up

Results reflect participants who requested to withdraw from the trial.

Group	Value	95% CI
Assessment Only	0
Intervention	2

Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports Primary · 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.

Week 1

Group	Value	95% CI
Intervention - Surveys, Text Messages, and Feedback Reports	37

Week 2

Group	Value	95% CI
Intervention - Surveys, Text Messages, and Feedback Reports	34

Week 3

Group	Value	95% CI
Intervention - Surveys, Text Messages, and Feedback Reports	29

Week 4

Group	Value	95% CI
Intervention - Surveys, Text Messages, and Feedback Reports	30

Week 5

Group	Value	95% CI
Intervention - Surveys, Text Messages, and Feedback Reports	26

Week 6

Group	Value	95% CI
Intervention - Surveys, Text Messages, and Feedback Reports	29

Percent of Participants (in the Intervention Arm) That Viewed a Personalized Feedback Report at Least Once Primary · 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.

Group	Value	95% CI
Intervention - Surveys, Text Messages, and Feedback Reports	70

Participant Self-reported Satisfaction With the Intervention Components - Assessment-only Primary · 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.

I am glad I participated in the study.

Group	Value	95% CI
Assessment Only	6.12	± 0.77

The weekly Sunday surveys helped me to reflect on how things were going in my life.

Group	Value	95% CI
Assessment Only	6.00	± 0.82

I would be willing to complete brief (~5 minute) weekly surveys during the year without compensation

Group	Value	95% CI
Assessment Only	3.24	± 1.64

My confidentiality and privacy was respected during this study.

Group	Value	95% CI
Assessment Only	6.20	± 0.87

Six weeks was too brief for this study period.

Group	Value	95% CI
Assessment Only	4.12	± 1.30

Participating in this study was beneficial for my health and well-being.

Group	Value	95% CI
Assessment Only	5.16	± 1.14

The system of receiving messages and completing surveys was convenient.

Group	Value	95% CI
Assessment Only	6.40	± 0.91

I liked participating in this study.

Group	Value	95% CI
Assessment Only	6.04	± 1.02

Participant Self-reported Satisfaction With the Intervention Components - Intervention Only Primary · 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.

I am glad that I participated in this study.

Group	Value	95% CI
Intervention	6.18	± 1.00

The daily 5-item surveys helped me to reflect on how things were going in my life.

Group	Value	95% CI
Intervention	5.90	± 1.11

The coping/support text-message strategies were useful for me.

Group	Value	95% CI
Intervention	4.31	± 1.73

I would be willing to complete brief (~5 minute) weekly surveys during the year without compensation

Group	Value	95% CI
Intervention	4.04	± 1.71

The personalized feedback reports provided valuable insight into how I was doing over time.

Group	Value	95% CI
Intervention	5.25	± 1.23

The number of coping/support text messages I received was… (1-too few, 4-just right, 7-too many)

Group	Value	95% CI
Intervention	4.18	± 1.36

Six weeks was too brief for this study period.

Group	Value	95% CI
Intervention	4.26	± 1.41

Participating in this study was beneficial for my health and well-being.

Group	Value	95% CI
Intervention	5.18	± 0.93

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Assessment Only

Serious: 0/30 (0%)

Deaths: 0/30

Intervention

Serious: 0/90 (0%)

Deaths: 0/90

Other adverse events (2 terms — click to expand)

Reaction	System	Assessment Only	Intervention
Moderately severe to severe depression	Psychiatric disorders	—	—
Suicidal ideation in the past week	Psychiatric disorders	—	—

Data from ClinicalTrials.gov NCT06583096 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Attitudes and barriers to mobile mental health interventions among first-year college students: a mixed-methods study.
   McCarthy K, Horwitz AG. · · 2025 · cited 2× · PMID 39868744 · DOI 10.1080/07448481.2025.2458085
2. Low-burden preventative digital mental health interventions for first-year college students: A pilot feasibility microrandomized trial.
   Horwitz AG, Anand S, Chen M, McCarthy K, et al · · 2026 · PMID 41647167 · DOI 10.1016/j.invent.2026.100912