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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH131761 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assessment Only | Other | Weekly surveys only. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveys | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline up to six-week follow-up |
| Number of Withdrawals | Results reflect participants who requested to withdraw from the trial. | 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. | Baseline up to six-week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Horwitz, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
De-identified IPD will be shared upon request following publication of primary results.
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Of the 126 individuals eligible to be randomized, 120 agreed to become randomized participants.
353 individuals were consented to be screened for participant eligibility, and 126 were determined to be eligible for the randomized trial portion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Assessment Only | Participants completed assessment surveys once per week over six weeks. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only eligible individuals who were randomized had baseline data collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Assessment Only | Participants completed assessment surveys once per week over six weeks. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis of this outcome measure occurred prior to randomization. 126 participants were eligible prior to randomization. | Posted | Count of Participants | Participants | Up to 10 days after screening survey |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Assessment Only | Participants completed assessment surveys once per week over six weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Moderately severe to severe depression | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Horwitz | University of Michigan | (734) 764-0231 | ahor@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2025 | Oct 23, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 23, 2024 | Mar 27, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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.
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| Supportive Text messages | Behavioral | 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. |
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| Personalized Feedback (PF) Report | Behavioral | 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. |
|
| 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. |
| 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. | 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. | Six-week follow-up |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Primary | 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. | Some participants did not complete weekly surveys consecutively. | Posted | Count of Participants | Participants | Baseline up to six-week follow-up |
|
|
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| Primary | 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. | Posted | Count of Participants | Participants | Baseline up to six-week follow-up |
|
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| Primary | Number of Withdrawals | Results reflect participants who requested to withdraw from the trial. | Posted | Count of Participants | Participants | Baseline up to six-week follow-up |
|
|
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| Primary | 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. | Not all participants were sent the feedback reports each week. | Posted | Count of Participants | Participants | Baseline up to six-week follow-up |
|
|
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| Primary | 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. | Posted | Count of Participants | Participants | Baseline up to six-week follow-up |
|
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| Primary | 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. | This includes the 26 (of 30) participants who completed the 6-week follow-up survey | Posted | Mean | Standard Deviation | units on a scale | Six-week follow-up |
|
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| Primary | 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. | This included the 78 (of 90) participants who completed the 6-week follow-up survey | Posted | Mean | Standard Deviation | score on a scale | Six-week follow-up |
|
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|
| 0 |
| 30 |
| 0 |
| 30 |
| 7 |
| 30 |
| EG001 | 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. | 0 | 90 | 0 | 90 | 17 | 90 |
| Suicidal ideation in the past week | Psychiatric disorders | Systematic Assessment |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Week 3 |
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| My confidentiality and privacy was respected during this study. |
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| Six weeks was too brief for this study period. |
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| Participating in this study was beneficial for my health and well-being. |
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| The system of receiving messages and completing surveys was convenient. |
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| I liked participating in this study. |
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| I would be willing to complete brief (~5 minute) weekly surveys during the year without compensation |
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| The personalized feedback reports provided valuable insight into how I was doing over time. |
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| The number of coping/support text messages I received was… (1-too few, 4-just right, 7-too many) |
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| Six weeks was too brief for this study period. |
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| Participating in this study was beneficial for my health and well-being. |
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| I would have liked to receive personalized feedback graphs every week. |
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| The weekly Sunday surveys helped me to reflect on how things were going in my life. |
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| I would be willing to complete brief (~1 minute) daily surveys during the year without compensation. |
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| The study's intervention meets my approval. |
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| The system of receiving messages and completing surveys was convenient. |
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| The study's intervention was appealing to me. |
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| A program like this study should be offered to all students. |
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| I would want to continue receiving surveys, texts, and personalized feedback reports after the study |
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| I like the intervention from this study. |
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| My confidentiality and privacy was respected during this study. |
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