Examining the Feasibility of a Mobile Mental Health Application (Ask RoSE) for Augmentation of In-person Psychotherapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Most commonly used feature within the app
研究概览
简要总结
Students are one of the most at-risk groups for mental illness and suicide. Up to 40% of persons with serious mental illnesses do not receive care or stop intervention programs due to negative stigma. Focusing on students, only 30% of universities provide mental health counseling as part of universities' student health services. There is an urgent need to better understand and manage the mental health burden among students. The investigators will use a mental health-focused application that utilizes artificial intelligence to identify symptoms and provides targeted, tailored in-person therapy solutions for its users. Once a patient is matched with a therapist, the application provides solutions to supplement ongoing in-person psychotherapy. This includes journaling and daily assessments that provide curated content and feedback. The current feasibility study aims to recruit 45 Johns Hopkins graduate students with at least mild depressive and/or anxiety symptoms who will be consented and enrolled in a five-week study. There are two study arms: (1) the intervention arm and (2) a waitlist control arm. During the course of the study, the participants in the intervention arm will use the application daily. Participants will receive weekly in-person psychotherapy for a total of four sessions over four weeks. Licensed therapists will provide the in-person psychotherapy. The participants in the waitlist arm will serve as controls unless there is attrition from the intervention group at which time waitlist participants will be offered a spot in the intervention arm. The primary objectives of the study are (1) To assess the usability of the application and (2) To evaluate the short-term impact on mood and anxiety of using the application to augment in-person psychotherapy.
详细描述
Problem description Students are one of the most at-risk groups for mental illness and suicide. Eight out of ten students experience stress frequently or daily for months at a time. A four-year prospective study with college students revealed that 12% had suicidal ideation sometime during the students' years at college. Students must manage family life, academics, extracurricular activities, hormonal changes, relationships, identity development, and much more. All these factors combined add stress to students' daily lives and can lead to depression, anxiety or other mental health conditions.
While mental illness negatively affects young adults in significant ways, primary care doctors identify less than one third of all depression cases and up to 40% of persons with serious mental illnesses do not receive care or stop intervention programs due to negative stigma. On the university side, only 30% of respondent universities in one study provided mental health counseling within universities' student health services and after-hour care was only available at 38% of the 129 respondents.
Study model This study uses is a mental health-focused application that utilizes artificial intelligence to identify symptoms and provides targeted, tailored in-person therapy solutions for its users. The application is meant to augment in-person psychotherapy utilizing online journaling and daily patient assessments to provide curated content and feedback. In brief, the application utilizes machine learning and artificial intelligence to select content (e.g., self-help articles) and provide feedback (e.g., weekly summary score of mood and anxiety) based on user input (e.g., journal entries, daily mood rating)
Study Design
The proposed study is a 5-week feasibility study to assess the usability and potential short-term benefits of the app platform in a population of Johns Hopkins medical students.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 28 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking;
- •21-28 years of age;
- •Full time Johns Hopkins University graduate student;
- •Score >5 on PHQ-9 and/or >5 on GAD-7;
- •Have accessible smartphone with data plan;
- •Ability to dedicate one hour a week for therapy sessions;
- •Ability to give informed consent and understand the tasks involved.
排除标准
- •Not living in Baltimore or surrounding counties as this will make it difficult to schedule on-campus therapy sessions;
- •Part-time students;
- •Students currently receiving psychiatric care.
结局指标
主要结局
Most commonly used feature within the app
时间窗: 5 weeks
For each session, the app keeps track of different in-app features that are used (mood meter, journal, insights, assessments). Over the 5 week period, we will rank the most commonly used features.
Change in Short term impact on mood as assessed by the Positive and Negative Emotions Scale (PANAS)
时间窗: Baseline, 5 weeks
The PANAS is a self-report questionnaire that consists of two 1-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much).
Average session time when using the mobile app
时间窗: 5 weeks
Over the 5 weeks of the study, the mobile app will collect time (seconds) the user spends within each session. We will calculate the average time the user spent on mobile app in each session.
Time of day the mobile app is used
时间窗: 5 weeks
Over the 5 weeks of using the mobile app, we will capture the time of data the app was used in ( morning, afternoon and evenings). We will derive proportions for the app use at these times of day
Change in Short term impact on anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) scale
时间窗: Baseline, 5 weeks
The GAD-7 is a self-administered 7 item instrument that uses some of the DSM-V criteria for anxiety to identify probable cases of GAD along with measuring anxiety symptom severity. Responders are asked to rate the frequency of anxiety symptoms in the last 2 weeks on a Likert scale ranging from 0-3.Severity can be determined by examining the total score. A meaningful change is 5 or more points.
次要结局
未报告次要终点