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The goal of this clinical trial is to learn if a mobile health app called mHELP can help college students manage anxiety, stress, and depression.
The main questions it aims to answer are:
Researchers will compare students who use the full version of the mHELP app to those who use a control version with limited features.
Participants will:
There will be two groups of participants:
Control (n=50): This group will receive an Apple Watch and an iPhone mobile application to 1) complete weekly assessments of their mental health using PSS-10, GAD-7, and PHQ-9, and 2) to self-report high-anxiety or high- stress events. The mobile or watch applications will not have any other functionality. This version of the app will also include information about mental health resources provided to them on TAMU campus.
Intervention (n=150): This group will receive the mHELP mobile and watch application with full functionality which provides weekly self-assessment and self-reported events PLUS self-management functionality. The self- management functionality includes additional on-demand features (see the attached list of features). These include
At the beginning of the study, participants in the intervention group are required to schedule and attend an introductory session with TAMU Telehealth Clinic. This service uses a video communication tool called MEND. mHELP provides a link to MEND registration but does collect any data about the telehealth sessions or any other information related to these visits. After their introductory session, participants are also required to schedule and attend a full session using MEND. If the participant wishes to continue using the telehealth services, they are allowed to do so, but it is not required. The telehealth clinic is staffed by qualified therapists from Texas A&M Telehealth Clinic.
The intervention group will also follow a case-control design for digital coaching/education: The first 5 weeks, participants will have access to educational content on demand. The second 5 weeks, participants will receive daily reminders to complete educational modules (e.g., short videos, posters, articles).
Each week will cover a different topic related to mental health:
Week 1 - Anxiety Week 2 - Sleep Week 3 - Depression Week 4 - Stress Week 5 - Grief/Relationships The purpose of the videos, posters, and articles provided is to help participants identify, recognize symptoms, and cope with each topic. The information was extracted from the TAMU Counseling and Psychological Services (CAPS) website.
Participants will be provided with consent forms prior to the start of any aspect of the study explaining the risks, benefits, time commitment. The study will start in late September and last until the last day of classes (10 weeks). Demographic information will be collected at the start of the study, including health, fitness status and lifestyle questionnaires. Students will be provided with a smartwatch and smartphone app, designed for convenient and momentary collection of self-reported events, and will be asked to wear the smartwatch continuously for the duration of the study. Participants will receive virtual instructions and practice on momentary assessments to enable self-reporting of anxiety and depression triggers. Participants will be instructed to tap anywhere on the smartwatch screen whenever they feel or perceive high anxiety and depression levels. Also, participants will receive notifications of stress moments detected by machine learning algorithms and respond to the notifications regarding whether the detection was correct or not. In addition, the investigators will obtain daily sleep logs via a smartphone app entry. At the start, middle, and end of the week, participants will be instructed to fill short online questionnaires on anxiety (using the Generalized Anxiety Disorder 7-item [GAD-7]), depression (using the Patient Health Questionnaire [PHQ-9], stress (using the 10-item Perceived Stress Scale [PSS-10]) and physical activity. Finally, participants will fill out a survey on intervention effectiveness pre-, mid-, and post-study. Periodic text reminders will be sent to participants to log the associated study measures via the smartphone app and will also add descriptions related to digital health coaching. A short exit interview will be conducted to collect information on students' experience with the app.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital intervention | Experimental | This group will receive the mHELP mobile and watch application with full functionality which provides weekly self-assessment and self-reported events PLUS self-management functionality. The self- management functionality includes additional on-demand features. |
|
| Non intervention | No Intervention | This group will receive an Apple Watch and an iPhone mobile application to 1) complete weekly assessments of their mental health using PSS-10, GAD-7, and PHQ-9, and 2) to self-report high-anxiety or high- stress events. The mobile or watch applications will not have any other functionality. This version of the app will also include information about mental health resources provided to them on TAMU campus. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile health application | Behavioral | This group will receive the mHELP mobile and watch application with full functionality which provides weekly self-assessment and self-reported events PLUS self-management functionality. The self- management functionality includes additional on-demand features (see the attached list of features). These include
|
| Measure | Description | Time Frame |
|---|---|---|
| Machine Learning detected Stress Moments | The primary dependent variable, "Moments of Stress" (MS), is a conceptual real-time measure derived from a combination of physiological heart rate (beats per minute - bpm) measurements and subjective self-reports, both collected through the mHELP application on the Apple Watch. Participants were prompted by the app after periods of elevated heart rate, identified using an integrated machine learning algorithm, to provide momentary self-assessments of stress using a single-item scale (e.g., "Are you feeling stressed right now?"), enabling an acute, context-sensitive capture of perceived stress. | From enrollment through completion of the study, an average of 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale (PSS) | A subjective measure of stress and psychological functioning, the PSS, was collected as a secondary outcome measure. Once a week, the mHELP app would prompt the students to take these psychological surveys. The PSS has a minimum score of 0 and a maximum score of 40, with a higher score indicating higher general perceived stress. | Weekly through study completion, an average of 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farzan Sasangohar, Ph.D. Industrial Engineering | Texas A&M University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas A&M University | College Station | Texas | 77843 | United States |
IPD will not be shared in this study as we plan to keep the personalized data private within the research personnel on the approved protocol. Rather, aggregate data will be published via journal article.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Participants will be randomly allocated in a 3:1 ratio into intervention and control groups respectively.
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|
| Generalized Anxiety Disorder 7-item Scale (GAD-7) | A subjective measure of anxiety and psychological functioning, the GAD-7, was collected as a secondary outcome measure. Once a week, the mHELP app would prompt the students to take these psychological surveys. The GAD-7 has a minimum score of 0 and a maximum score of 21, with a higher score indicating higher symptoms of anxiety. | Weekly through study completion, an average of 12 weeks |
| Patient Health Questionnaire - 8 (PHQ-8) | A subjective measure of depression and psychological functioning, the PHQ-8, was collected as a secondary outcome measure. Once a week, the mHELP app would prompt the students to take these psychological surveys. The PHQ-8 has a minimum score of 0 and a maximum score of 24, with a higher score indicating higher symptoms of depression. | Weekly through study completion, an average of 12 weeks |