Examining the Feasibility of a Mobile Mental Health Application (Rose) for Augmentation of In-person Psychotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Average weekly completion rate for Mood check-in
研究概览
简要总结
There is an urgent need to better understand and manage the mental health burden among working adults. Up to 40% of persons with serious mental illnesses do not receive care or stop intervention programs due to negative stigma. Additionally, nearly 50 percent of respondents diagnosed with an anxiety disorder said it interfered with their relationships with coworkers. Close to $6000 USD is lost per working person each year due to depression and its effects.
Rose (Recognition of Speech and Emotion) 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 RoSE 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 established outpatients with at least mild depressive and/or anxiety symptoms who will be consented and enrolled in a five to ten-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 RoSE application daily. They will receive either weekly in-person psychotherapy with their established psychotherapist for a total of four sessions over four weeks or biweekly in-person psychotherapy with their established psychotherapist for a total of four sessions over eight weeks. 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 RoSE application and (2) To evaluate the short-term impact on mood and anxiety of using the RoSE application to augment in-person psychotherapy. The secondary objectives are (1) To examine the usage and utility of an in-application journaling function and (2) To examine the usage and utility of in-application curated insights.
详细描述
Problem description Mental illness among working adults is of huge detriment to society on a large scale. Not only does mental illness lead to a lower quality of life and negative outcomes for the individual, but it places a burden on the economy, resulting in lost productivity, lost workdays and reduced economic growth. According to the National Institute of Mental Health an estimated 17.3 million adults in the United States had at least one major depressive episode in 2017. This number represented 7.1% of all U.S. adults. Furthermore, according to ADAA anxiety is one of the most common mental illnesses in America with around 40 million adults in the US having anxiety disorders every year. In addition to the millions lost on medical costs from mental illness, studies show an added societal burden. On average depressive symptoms can lead to close to 27 lost workdays per year and 18 days of lost productivity.
While mental illness negatively affects 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. With only one in four adults disclosing their anxiety disorder in time, a much smaller proportion are ever diagnosed and receive treatment for major depression. Lastly, but perhaps most importantly, according to the Center for Workplace Mental Health, 80 percent of adults treated for mental health problems report improvements in their overall satisfaction and productivity.
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 mental health platform in a population of adults with established mental health care.
Potential participants will be informed of the study using study brochures provided to their established psychotherapists. All written materials are submitted for approval. Interested patients will be directed to a secure online survey, which will screen them for eligibility. Patients that meet all inclusion criteria and no exclusion criteria will be offered entrance into the study. Of note, no medical records of the patients will be accessed as part of the study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking;
- •>=18 years of age;
- •Score >5 on PHQ-9 and/or >5 on GAD-7;
- •Have an accessible smartphone with a 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
- •Current psychosis (e.g., hallucinations, delusions, thought disorder);
- •Current suicidal ideation or homicidal ideation
结局指标
主要结局
Average weekly completion rate for Mood check-in
时间窗: 4 weeks
Over the study period, the mobile app will collect time (date/time) the user fills in the Mood Likert Scale. We will calculate the average number of times the user fills in the scale each week.
Average weekly completion rate for online journaling
时间窗: 4 weeks
Over the study period, the mobile app will collect time (date/time) the user fills the online journal. We will calculate the average number of times the user fills in the scale each week.
Adherence to Patient Health Questionnaire-9 (PHQ-9) survey completion at Week 2
时间窗: Week 2
Over the study period, the mobile app will prompt the user to fill in the PHQ-9 survey. The app will collect time (date/time) the user fills this in. We will record the level of adherence: Full ( Week 2 filled) vs. Partial (Week 2 not filled)
Adherence to General Anxiety Disorder-7 (GAD-7) survey completion at Week 2
时间窗: Week 2
Over the study period, the mobile app will prompt the user to fill in the GAD-7 survey. The app will collect time (date/time) the user fills this in. We will record the level of adherence: Full ( Week 2 filled) vs. Partial (Week 2 not filled)
Average weekly completion rate for Anxiety check-in
时间窗: 4 weeks
Over the study period, the mobile app will collect time (date/time) the user fills in the Anxiety Likert Scale. We will calculate the average number of times the user fills in the scale each week.
Adherence to Patient Health Questionnaire-9 (PHQ-9) survey completion at Baseline
时间窗: Baseline
Over the study period, the mobile app will prompt the user to fill in the PHQ-9 survey. The app will collect time (date/time) the user fills this in. We will record the level of adherence: Full ( Baseline filled) vs. Partial (Baseline not filled)
Assess objective and subjective quality of mobile app used
时间窗: Week 5
At the end of the study (week 5), participants will be asked to complete the Mobile Application Rating Scale (MARS) to score the intervention app on the criteria of engagement, functionality, aesthetics, and information quality, as well as app subjective quality. Each MARS item used a 5-point scale (1-Inadequate, 2-Poor, 3-Acceptable, 4-Good, 5-Excellent). The MARS is calculated as mean scores of the engagement, functionality, aesthetics, and information quality objective sub-scales, and an overall mean app quality total score.
Adherence to General Anxiety Disorder-7 (GAD-7) survey completion at Baseline
时间窗: Baseline
Over the study period, the mobile app will prompt the user to fill in the GAD-7 survey. The app will collect time (date/time) the user fills this in. We will record the level of adherence: Full ( Baseline filled) vs. Partial (Baseline not filled)
Adherence to General Anxiety Disorder-7 (GAD-7) survey completion at Week 4
时间窗: Week 4
Over the study period, the mobile app will prompt the user to fill in the PHQ-9 survey. The app will collect time (date/time) the user fills this in. We will record the level of adherence: Full ( Week 4 filled) vs. Partial (Week 4 not filled)
次要结局
- Change in Short term impact on anxiety as assessed by the GAD-7(Baseline, 4 weeks)
- Change in Short term impact on anxiety as assessed by the PHQ-9(Baseline, 4 weeks)
研究者
Ameena Jain, DNP, CRNP
Principal Investigator
Key Point Health Services, Inc.