Trial Outcomes & Findings for College Student Stress: Transitions Over Time (NCT NCT06583096)
NCT ID: NCT06583096
Last Updated: 2025-12-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Up to 10 days after screening survey
Results posted on
2025-12-04
Participant Flow
353 individuals were consented to be screened for participant eligibility, and 126 were determined to be eligible for the randomized trial portion.
Of the 126 individuals eligible to be randomized, 120 agreed to become randomized participants.
Participant milestones
| Measure |
Assessment Only
Participants completed assessment surveys once per week over six weeks.
|
Intervention
Participants completed assessment surveys once per week over six weeks. Participants in this arm also completed brief (1-minute) daily surveys during this period. Participants in the intervention arm were 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 were randomized each week to receive (or not receive) personalized feedback reports.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
90
|
|
Overall Study
COMPLETED
|
26
|
78
|
|
Overall Study
NOT COMPLETED
|
4
|
12
|
Reasons for withdrawal
| Measure |
Assessment Only
Participants completed assessment surveys once per week over six weeks.
|
Intervention
Participants completed assessment surveys once per week over six weeks. Participants in this arm also completed brief (1-minute) daily surveys during this period. Participants in the intervention arm were 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 were randomized each week to receive (or not receive) personalized feedback reports.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
10
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
College Student Stress: Transitions Over Time
Baseline characteristics by cohort
| Measure |
Assessment Only
n=30 Participants
Participants completed assessment surveys once per week over six weeks.
|
Intervention
n=90 Participants
Participants completed assessment surveys once per week over six weeks. Participants in this arm also completed brief (1-minute) daily surveys during this period. Participants in the intervention arm were 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 were randomized each week to receive (or not receive) personalized feedback reports.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
17 years
|
4 Participants
n=3 Participants
|
12 Participants
n=3 Participants
|
16 Participants
n=6 Participants
|
|
Age, Customized
18 years
|
23 Participants
n=3 Participants
|
67 Participants
n=3 Participants
|
90 Participants
n=6 Participants
|
|
Age, Customized
19 years
|
3 Participants
n=3 Participants
|
9 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
|
Age, Customized
20 - 25 years
|
0 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
|
Sex/Gender, Customized
Male
|
10 Participants
n=3 Participants
|
28 Participants
n=3 Participants
|
38 Participants
n=6 Participants
|
|
Sex/Gender, Customized
Female
|
19 Participants
n=3 Participants
|
58 Participants
n=3 Participants
|
77 Participants
n=6 Participants
|
|
Sex/Gender, Customized
Transgender/Non-binary
|
1 Participants
n=3 Participants
|
4 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=3 Participants
|
9 Participants
n=3 Participants
|
12 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=3 Participants
|
81 Participants
n=3 Participants
|
108 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=3 Participants
|
17 Participants
n=3 Participants
|
20 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=3 Participants
|
7 Participants
n=3 Participants
|
9 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=3 Participants
|
53 Participants
n=3 Participants
|
76 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=3 Participants
|
11 Participants
n=3 Participants
|
13 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=3 Participants
|
90 Participants
n=3 Participants
|
120 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Up to 10 days after screening surveyPopulation: Analysis of this outcome measure occurred prior to randomization. 126 participants were eligible prior to randomization.
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.
Outcome measures
| Measure |
Eligible Participants
n=126 Participants
Participants completed the screen and were eligible for enrollment and subsequent randomization
|
Intervention
Participants completed assessment surveys once per week over six weeks. Participants in this arm also completed brief (1-minute) daily surveys during this period. Participants in the intervention arm were 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 were randomized each week to receive (or not receive) personalized feedback reports.
|
|---|---|---|
|
Percentage of Eligible Participants Who Agreed to Participate in the Trial
|
120 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline up to six-week follow-upPopulation: Some participants did not complete weekly surveys consecutively.
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.
Outcome measures
| Measure |
Eligible Participants
n=30 Participants
Participants completed the screen and were eligible for enrollment and subsequent randomization
|
Intervention
n=90 Participants
Participants completed assessment surveys once per week over six weeks. Participants in this arm also completed brief (1-minute) daily surveys during this period. Participants in the intervention arm were 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 were randomized each week to receive (or not receive) personalized feedback reports.
|
|---|---|---|
|
Percentage of Participants Who Completed Follow-ups
Week 5
|
24 Participants
|
76 Participants
|
|
Percentage of Participants Who Completed Follow-ups
Week 6
|
26 Participants
|
78 Participants
|
|
Percentage of Participants Who Completed Follow-ups
Week 4
|
25 Participants
|
78 Participants
|
|
Percentage of Participants Who Completed Follow-ups
Week 1
|
23 Participants
|
81 Participants
|
|
Percentage of Participants Who Completed Follow-ups
Week 2
|
23 Participants
|
80 Participants
|
|
Percentage of Participants Who Completed Follow-ups
Week 3
|
24 Participants
|
79 Participants
|
PRIMARY outcome
Timeframe: Baseline up to six-week follow-upResults reflect the participants who remained active during the full trial in the intervention group.
Outcome measures
| Measure |
Eligible Participants
n=90 Participants
Participants completed the screen and were eligible for enrollment and subsequent randomization
|
Intervention
Participants completed assessment surveys once per week over six weeks. Participants in this arm also completed brief (1-minute) daily surveys during this period. Participants in the intervention arm were 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 were randomized each week to receive (or not receive) personalized feedback reports.
|
|---|---|---|
|
Percentage of Participants That Remain Active (i.e. do Not Request to Stop Messages) on the Text-message Group
|
88 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline up to six-week follow-upResults reflect participants who requested to withdraw from the trial.
Outcome measures
| Measure |
Eligible Participants
n=30 Participants
Participants completed the screen and were eligible for enrollment and subsequent randomization
|
Intervention
n=90 Participants
Participants completed assessment surveys once per week over six weeks. Participants in this arm also completed brief (1-minute) daily surveys during this period. Participants in the intervention arm were 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 were randomized each week to receive (or not receive) personalized feedback reports.
|
|---|---|---|
|
Number of Withdrawals
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline up to six-week follow-upPopulation: Not all participants were sent the feedback reports each week.
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.
Outcome measures
| Measure |
Eligible Participants
n=90 Participants
Participants completed the screen and were eligible for enrollment and subsequent randomization
|
Intervention
Participants completed assessment surveys once per week over six weeks. Participants in this arm also completed brief (1-minute) daily surveys during this period. Participants in the intervention arm were 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 were randomized each week to receive (or not receive) personalized feedback reports.
|
|---|---|---|
|
Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports
Week 1
|
37 Participants
|
—
|
|
Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports
Week 2
|
34 Participants
|
—
|
|
Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports
Week 3
|
29 Participants
|
—
|
|
Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports
Week 4
|
30 Participants
|
—
|
|
Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports
Week 5
|
26 Participants
|
—
|
|
Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports
Week 6
|
29 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline up to six-week follow-upAs 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.
Outcome measures
| Measure |
Eligible Participants
n=90 Participants
Participants completed the screen and were eligible for enrollment and subsequent randomization
|
Intervention
Participants completed assessment surveys once per week over six weeks. Participants in this arm also completed brief (1-minute) daily surveys during this period. Participants in the intervention arm were 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 were randomized each week to receive (or not receive) personalized feedback reports.
|
|---|---|---|
|
Percent of Participants (in the Intervention Arm) That Viewed a Personalized Feedback Report at Least Once
|
70 Participants
|
—
|
PRIMARY outcome
Timeframe: Six-week follow-upPopulation: This includes the 26 (of 30) participants who completed the 6-week follow-up survey
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.
Outcome measures
| Measure |
Eligible Participants
n=26 Participants
Participants completed the screen and were eligible for enrollment and subsequent randomization
|
Intervention
Participants completed assessment surveys once per week over six weeks. Participants in this arm also completed brief (1-minute) daily surveys during this period. Participants in the intervention arm were 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 were randomized each week to receive (or not receive) personalized feedback reports.
|
|---|---|---|
|
Participant Self-reported Satisfaction With the Intervention Components - Assessment-only
I am glad I participated in the study.
|
6.12 units on a scale
Standard Deviation 0.77
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Assessment-only
The weekly Sunday surveys helped me to reflect on how things were going in my life.
|
6.00 units on a scale
Standard Deviation 0.82
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Assessment-only
I would be willing to complete brief (~5 minute) weekly surveys during the year without compensation
|
3.24 units on a scale
Standard Deviation 1.64
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Assessment-only
My confidentiality and privacy was respected during this study.
|
6.20 units on a scale
Standard Deviation 0.87
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Assessment-only
Six weeks was too brief for this study period.
|
4.12 units on a scale
Standard Deviation 1.30
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Assessment-only
Participating in this study was beneficial for my health and well-being.
|
5.16 units on a scale
Standard Deviation 1.14
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Assessment-only
The system of receiving messages and completing surveys was convenient.
|
6.40 units on a scale
Standard Deviation 0.91
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Assessment-only
I liked participating in this study.
|
6.04 units on a scale
Standard Deviation 1.02
|
—
|
PRIMARY outcome
Timeframe: Six-week follow-upPopulation: This included the 78 (of 90) participants who completed the 6-week follow-up survey
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.
Outcome measures
| Measure |
Eligible Participants
n=78 Participants
Participants completed the screen and were eligible for enrollment and subsequent randomization
|
Intervention
Participants completed assessment surveys once per week over six weeks. Participants in this arm also completed brief (1-minute) daily surveys during this period. Participants in the intervention arm were 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 were randomized each week to receive (or not receive) personalized feedback reports.
|
|---|---|---|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
I am glad that I participated in this study.
|
6.18 score on a scale
Standard Deviation 1.00
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
The daily 5-item surveys helped me to reflect on how things were going in my life.
|
5.90 score on a scale
Standard Deviation 1.11
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
The coping/support text-message strategies were useful for me.
|
4.31 score on a scale
Standard Deviation 1.73
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
I would be willing to complete brief (~5 minute) weekly surveys during the year without compensation
|
4.04 score on a scale
Standard Deviation 1.71
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
The personalized feedback reports provided valuable insight into how I was doing over time.
|
5.25 score on a scale
Standard Deviation 1.23
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
The number of coping/support text messages I received was… (1-too few, 4-just right, 7-too many)
|
4.18 score on a scale
Standard Deviation 1.36
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
Six weeks was too brief for this study period.
|
4.26 score on a scale
Standard Deviation 1.41
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
Participating in this study was beneficial for my health and well-being.
|
5.18 score on a scale
Standard Deviation 0.93
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
I would have liked to receive personalized feedback graphs every week.
|
4.75 score on a scale
Standard Deviation 1.48
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
The weekly Sunday surveys helped me to reflect on how things were going in my life.
|
5.51 score on a scale
Standard Deviation 0.94
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
I would be willing to complete brief (~1 minute) daily surveys during the year without compensation.
|
4.03 score on a scale
Standard Deviation 1.62
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
The study's intervention meets my approval.
|
5.35 score on a scale
Standard Deviation 0.98
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
The system of receiving messages and completing surveys was convenient.
|
6.09 score on a scale
Standard Deviation 0.81
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
The study's intervention was appealing to me.
|
5.44 score on a scale
Standard Deviation 0.99
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
A program like this study should be offered to all students.
|
5.61 score on a scale
Standard Deviation 1.16
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
I would want to continue receiving surveys, texts, and personalized feedback reports after the study
|
4.12 score on a scale
Standard Deviation 1.58
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
I like the intervention from this study.
|
5.12 score on a scale
Standard Deviation 1.00
|
—
|
|
Participant Self-reported Satisfaction With the Intervention Components - Intervention Only
My confidentiality and privacy was respected during this study.
|
5.97 score on a scale
Standard Deviation 0.90
|
—
|
Adverse Events
Assessment Only
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Intervention
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Assessment Only
n=30 participants at risk
Participants completed assessment surveys once per week over six weeks.
|
Intervention
n=90 participants at risk
Participants completed assessment surveys once per week over six weeks. Participants in this arm also completed brief (1-minute) daily surveys during this period. Participants in the intervention arm were 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 were randomized each week to receive (or not receive) personalized feedback reports.
|
|---|---|---|
|
Psychiatric disorders
Moderately severe to severe depression
|
23.3%
7/30 • 6 weeks
|
14.4%
13/90 • 6 weeks
|
|
Psychiatric disorders
Suicidal ideation in the past week
|
3.3%
1/30 • 6 weeks
|
4.4%
4/90 • 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place