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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
What is being tested?
Mobile health application
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.

United States1 site
  • Texas A&M University

    College Station, Texas, 77843

Other trials in United States

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:

  1. 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.
  2. 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.

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 groups in NCT07017569
Study groupRoleWhat they receive
Digital interventionExperimentalThis 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 interventionNo interventionThis 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted12 Jun 2025
  2. Study start20 Sep 2021
  3. Primary completion15 Dec 2021
  4. Study completion15 Dec 2021

Resources

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)
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.

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.

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