AnxietyNCT07017569
An Interactive Mobile Health (mHealth) App as Intervention for High Anxiety and Depression in College Students
A study testing Mobile health application in people with Anxiety and Depression - Major Depressive Disorder, run by Texas A&M University at 1 site in United States.
Trial summary
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: Does using the mHELP app reduce anxiety, stress, and depression symptoms both over time and in real-time? Does the app help… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Depression - Major Depressive Disorder, Stress
- What is being tested?
- Mobile health application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants should be 18 years or older.
- Participants should have an iPhone with at least iOS14
- Participants recently sought out resources to help with mental health problems they have experienced.
- Participants must score above a 7 on the GAD-7, to indicate probably Generalized Anxiety Disorder and at least moderate anxiety symptoms.
- Participants should be able to communicate in English.
Who cannot join
- Participants should not have severe anxiety/panic attacks, a history of suicidal attempt, current suicidal ideation, or current self-harm.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design and Development of an Interactive Mobile Health (mHealth) App to Provide Momentary and Periodic Intervention for High Anxiety and Depression
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:
Read more
- Does using the mHELP app reduce anxiety, stress, and depression symptoms both over time and in real-time?
- Does the app help students engage with mental health services and self-management tools?
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:
- Use an Apple Watch and iPhone app for 10 weeks
- Receive reminders to complete weekly mental health questionnaires
- Tap a button to report high-stress moments or respond to automatic alerts from the app
- Intervention group will use app features like breathing exercises, journaling, and educational videos
- Intervention group will receive 2 free telehealth counseling sessions
Read the detailed description
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
- a breath functionality that provides a times breathing exercise similar to the one provided by the Apple iWatch; users can see changes in their heart rate during the breathing exercise and will see a summary of heart rate changes
- a calendar features that allows students to upload their class schedule and see different activities such as self-assessments
- a journaling feature that allows participants to write a journal
- a task list to take note of major tasks and add them to calendar
- a set of relaxation media including videos and audios that participants can use on demand No data will be collected on these activities except for overall usage time to assess engagement.
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.
- Conditions
- Anxiety, Depression - Major Depressive Disorder, Stress
- Being tested
- Mobile health application
- Keywords
- Machine Learning, Mobile Health, Psychological Stress, Wearable Devices, College Students
- Medical subject headings
- Anxiety Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health applicationBehavioural
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
- a breath functionality that provides a times breathing exercise similar to the one provided by the Apple iWatch; users can see changes in their heart rate during the breathing exercise and will see a summary of heart rate changes
- a calendar features that allows students to upload their class schedule and see different activities such as self-assessments
- a journaling feature that allows participants to write a journal
- a task list to take note of major tasks and add them to calendar
- a set of relaxation media including videos and audios that participants can use on demand
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mobile health application |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment through completion of the study, an average of 12 weeks
Secondary outcomes (3)
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.
Measured: Weekly through study completion, an average of 12 weeks
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.
Measured: 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.
Measured: Weekly through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start20 Sep 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated in a 3:1 ratio into intervention and control groups respectively.
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farzan Sasangohar, Ph.D. Industrial Engineering, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017569
- Sponsor's protocol ID
- IRB2020-0162DCR
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Development of an Interactive Mobile Health (mHealth) App to Provide Momentary and Periodic Intervention for High Anxiety and Depression
- ClinicalTrials.gov ID
- NCT07017569
- Acronym / sponsor ID
- IRB2020-0162DCR
- Conditions
- Anxiety, Depression - Major Depressive Disorder, Stress
- Keywords
- Machine Learning, Mobile Health, Psychological Stress, Wearable Devices, College Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does using the mHELP app reduce anxiety, stress, and depression symptoms both over time and in real-time?
- Does the app help students engage with mental health services and self-management tools?
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:
- Use an Apple Watch and iPhone app for 10 weeks
- Receive reminders to complete weekly mental health questionnaires
- Tap a button to report high-stress moments or respond to automatic alerts from the app
- Intervention group will use app features like breathing exercises, journaling, and educational videos
- Intervention group will receive 2 free telehealth counseling sessions
Detailed description
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
- a breath functionality that provides a times breathing exercise similar to the one provided by the Apple iWatch; users can see changes in their heart rate during the breathing exercise and will see a summary of heart rate changes
- a calendar features that allows students to upload their class schedule and see different activities such as self-assessments
- a journaling feature that allows participants to write a journal
- a task list to take note of major tasks and add them to calendar
- a set of relaxation media including videos and audios that participants can use on demand No data will be collected on these activities except for overall usage time to assess engagement.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated in a 3:1 ratio into intervention and control groups respectively.
| Arm | Type | Receives |
|---|---|---|
| Digital intervention | Experimental | Behavioral: Mobile health applicationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants should be 18 years or older.
- Participants should have an iPhone with at least iOS14
- Participants recently sought out resources to help with mental health problems they have experienced.
- Participants must score above a 7 on the GAD-7, to indicate probably Generalized Anxiety Disorder and at least moderate anxiety symptoms.
- Participants should be able to communicate in English.
Key exclusion criteria (1 listed)
- Participants should not have severe anxiety/panic attacks, a history of suicidal attempt, current suicidal ideation, or current self-harm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile health applicationThis 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 * a breath functionality that provides a times breathing exercise similar to the one provided by the Apple iWatch; users can see changes in their heart rate during the breathing exercise and will see a summary of heart rate changes * a calendar features that allows students to upload their class schedule and see different activities such as self-assessments * a journaling feature that allows participants to write a journal * a task list to take note of major tasks and add them to calendar * a set of relaxation media including videos and audios that participants can use on demand | Behavioural | Digital intervention |
Primary outcome
Machine Learning detected Stress Moments
Time frame: From enrollment through completion of the study, an average of 12 weeks
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.
3 secondary outcomes
Perceived Stress Scale (PSS)
Time frame: Weekly through study completion, an average of 12 weeks
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Time frame: Weekly through study completion, an average of 12 weeks
Patient Health Questionnaire - 8 (PHQ-8)
Time frame: Weekly through study completion, an average of 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farzan Sasangohar, Ph.D. Industrial Engineering principal investigator
Texas A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health application in people with Anxiety and Depression - Major Depressive Disorder, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Machine Learning detected Stress Moments (time frame: From enrollment through completion of the study, an average of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.