Design and Development of an Interactive Mobile Health (mHealth) App to Provide Momentary and Periodic Intervention for High Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Machine Learning detected Stress Moments
研究概览
简要总结
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
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Participants should not have severe anxiety/panic attacks, a history of suicidal attempt, current suicidal ideation, or current self-harm.
研究组 & 干预措施
Digital intervention
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.
干预措施: Mobile health application (Behavioral)
Non 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.
结局指标
主要结局
Machine Learning detected Stress Moments
时间窗: 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.
次要结局
- 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)