An Interactive Mobile Health (mHealth) App as Intervention for High Anxiety and Depression in College Students

NCT07017569 | Completed

• 1 other identifier: IRB2020-0162DCR
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Anxiety; Depression - Major Depressive Disorder; Stress

Keywords

Machine Learning; Mobile Health; Psychological Stress; Wearable Devices; College Students

Outcome Measures

Primary Outcomes (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.

  From enrollment through completion of the study, an average of 12 weeks

Secondary Outcomes (3)

• Perceived Stress Scale (PSS)

  Weekly through study completion, an average of 12 weeks

• Generalized Anxiety Disorder 7-item Scale (GAD-7)

  Weekly through study completion, an average of 12 weeks

• Patient Health Questionnaire - 8 (PHQ-8)

  Weekly through study completion, an average of 12 weeks

Study Arms (2)

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.

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.

Interventions

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 * 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

Digital intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants should not have severe anxiety/panic attacks, a history of suicidal attempt, current suicidal ideation, or current self-harm.

Sponsors & Collaborators

• Texas A&M University: lead

Study Sites (1)

Texas A&M University

College Station, Texas, 77843, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Stress, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Farzan Sasangohar, Ph.D. Industrial Engineering

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated in a 3:1 ratio into intervention and control groups respectively.

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 12, 2025
• Study Start: September 20, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)