Depressive Symptoms
Conditions
Keywords
First-year college student, Surveys, Supportive text messages, Stress, Personalized feedback
Brief 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. 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.
Interventions
BEHAVIORALSurveys
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.
BEHAVIORALSupportive Text messages
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.
BEHAVIORALPersonalized Feedback (PF) Report
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.
Sponsors
National Institute of Mental Health (NIMH)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eligible Participants Who Agreed to Participate in the Trial | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
353 individuals were consented to be screened for participant eligibility, and 126 were determined to be eligible for the randomized trial portion.
Pre-assignment details
Of the 126 individuals eligible to be randomized, 120 agreed to become randomized participants.
Participants by arm
| Arm | Count |
|---|---|
| Assessment Only Participants completed assessment surveys once per week over six weeks. | 30 |
| 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. | 90 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 10 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Assessment Only | Intervention | Total |
|---|---|---|---|
| Age, Customized 17 years | 4 Participants | 12 Participants | 16 Participants |
| Age, Customized 18 years | 23 Participants | 67 Participants | 90 Participants |
| Age, Customized 19 years | 3 Participants | 9 Participants | 12 Participants |
| Age, Customized 20 - 25 years | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 9 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 81 Participants | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 17 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 7 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 11 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 23 Participants | 53 Participants | 76 Participants |
| Region of Enrollment United States | 30 Participants | 90 Participants | 120 Participants |
| Sex/Gender, Customized Female | 19 Participants | 58 Participants | 77 Participants |
| Sex/Gender, Customized Male | 10 Participants | 28 Participants | 38 Participants |
| Sex/Gender, Customized Transgender/Non-binary | 1 Participants | 4 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 90 |
| other Total, other adverse events | 7 / 30 | 17 / 90 |
| serious Total, serious adverse events | 0 / 30 | 0 / 90 |
Outcome results
Primary
Number of Withdrawals
Results reflect participants who requested to withdraw from the trial.
Time frame: Baseline up to six-week follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Participants | Number of Withdrawals | 0 Participants |
| Intervention | Number of Withdrawals | 2 Participants |
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.
Time frame: Six-week follow-up
Population: This includes the 26 (of 30) participants who completed the 6-week follow-up survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 1.3 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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
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.
Time frame: Six-week follow-up
Population: This included the 78 (of 90) participants who completed the 6-week follow-up survey
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 |
| Eligible Participants | 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 0.9 |
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.
Time frame: Up to 10 days after screening survey
Population: Analysis of this outcome measure occurred prior to randomization. 126 participants were eligible prior to randomization.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Participants | Percentage of Eligible Participants Who Agreed to Participate in the Trial | 120 Participants |
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.
Time frame: Baseline up to six-week follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Participants | Percentage of Participants That Remain Active (i.e. do Not Request to Stop Messages) on the Text-message Group | 88 Participants |
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.
Time frame: Baseline up to six-week follow-up
Population: Some participants did not complete weekly surveys consecutively.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eligible Participants | Percentage of Participants Who Completed Follow-ups | Week 1 | 23 Participants |
| Eligible Participants | Percentage of Participants Who Completed Follow-ups | Week 2 | 23 Participants |
| Eligible Participants | Percentage of Participants Who Completed Follow-ups | Week 3 | 24 Participants |
| Eligible Participants | Percentage of Participants Who Completed Follow-ups | Week 4 | 25 Participants |
| Eligible Participants | Percentage of Participants Who Completed Follow-ups | Week 5 | 24 Participants |
| Eligible Participants | Percentage of Participants Who Completed Follow-ups | Week 6 | 26 Participants |
| Intervention | Percentage of Participants Who Completed Follow-ups | Week 5 | 76 Participants |
| Intervention | Percentage of Participants Who Completed Follow-ups | Week 1 | 81 Participants |
| Intervention | Percentage of Participants Who Completed Follow-ups | Week 4 | 78 Participants |
| Intervention | Percentage of Participants Who Completed Follow-ups | Week 2 | 80 Participants |
| Intervention | Percentage of Participants Who Completed Follow-ups | Week 6 | 78 Participants |
| Intervention | Percentage of Participants Who Completed Follow-ups | Week 3 | 79 Participants |
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.
Time frame: Baseline up to six-week follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Eligible Participants | Percent of Participants (in the Intervention Arm) That Viewed a Personalized Feedback Report at Least Once | 70 Participants |
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.
Time frame: Baseline up to six-week follow-up
Population: Not all participants were sent the feedback reports each week.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Eligible Participants | Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports | Week 1 | 37 Participants |
| Eligible Participants | Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports | Week 2 | 34 Participants |
| Eligible Participants | Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports | Week 3 | 29 Participants |
| Eligible Participants | Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports | Week 4 | 30 Participants |
| Eligible Participants | Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports | Week 5 | 26 Participants |
| Eligible Participants | Total Percent of Feedback Reports That Were Viewed Across All Sent Feedback Reports | Week 6 | 29 Participants |