Evaluating the Use of a Mobile App to Reduce Symptoms of Depression and Anxiety for Students Seeking Care at Harvard University Health Services
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire - 9 (PHQ-9)
研究概览
简要总结
Brief Summary:
Background:
There is a growing demand for mental health services on college campuses. At the same time there has been a dramatic surge in development of mobile mental health apps. Given the widespread popularity and utilization of mobile apps in the college-age population, there is an opportunity to leverage these tools to improve services. The study aims to evaluate the effects of a mobile app on reducing symptoms of depression and anxiety for students awaiting their first visit at Harvard Counseling and Mental Health Services (CAMHS), and on enhancing recovery after beginning treatment.
Methods:
Students seeking an appointment at Harvard CAMHS who meet eligibility criteria will be randomized to receive one of two apps: a direct online social support (7cups) or an app that provides information about community, health, wellness, academic, and support resources on campus (Bliss). Participants will complete a baseline assessment using the PHQ-9 and GAD-7 and a measure of perceived social support. They will be asked to use their assigned app while awaiting their intake appointment and during treatment. The primary endpoint will be at 2 weeks after enrollment and the secondary endpoints at 4, 8- and 12 weeks after enrollment. At all endpoints participants will complete a PHQ-9, GAD-7 and a survey assessing their experience with the app. At the 8-week endpoint they will also be asked about their overall satisfaction with their care and their perceived social support.
Results:
Feasibility and acceptability of the app will be evaluated by analyzing usage metrics of the 7cups app, self-report satisfaction questionnaire as well as trial adherence. Changes in PHQ-9 and GAD-7 scores between the two groups at baseline, primary and secondary endpoints will be analyzed as well as associations between PHQ-9, GAD-7 scores and patient socio-demographic and social support variables. Mediators of change in symptoms including frequency of use, activities used on app and perceived social support will also be analyzed.
详细描述
Abstract:
There is a growing demand for mental health services on college campuses. At the same time there has been a dramatic surge in development of mobile apps for mental health. Given the widespread popularity and utilization of mobile apps in the college-age population, there is an opportunity to leverage these tools to improve services. The study aims to evaluate the effects of a mobile mental health app on reducing symptoms of depression and anxiety for students awaiting their first visit at Harvard Counseling and Mental Health Services (CAMHS), and Harvard graduate students who have been recommended to seek treatment at CAMHS. The feasibility and acceptability of a mobile app intervention with this population will also be assessed, as well as the ways through which the mobile app may contribute to improvement in depression and anxiety among students such as change in perceived social support for students using a mobile social support app.
Specific Aims:
Untreated or under-treated depression and anxiety in college-age students has tremendous costs for the individual, the larger community and society at large, with the worst, fatal outcome of suicide leading to devastating consequences for college communities. 64% of young adults who are no longer in college are not attending college because of a mental health related condition and the frequency that students in treatment report having "seriously considered suicide" has increased by almost 40% in the last five years. Despite these facts, still only 25% of students with a mental health concern seek treatment. Technological innovations such as mobile apps hold promise to improve access to care, de-stigmatize treatment and potentially alleviate demand on over-burdened service centers. However, there is limited evidence on the effectiveness and feasibility of use of these mobile platforms. Consequently, there is a pressing need to develop better research modalities for evaluating mobile apps and to elucidate the specific features that are effective at reducing symptoms and are acceptable in this population in order to improve care and inform novel treatment approaches.
In this study, participants seeking mental health services at a university health center will receive a mobile social support app. The investigators hypothesize that receiving immediate access to a mobile, anonymous social support app while waiting for an appointment and during treatment will be feasible and acceptable to young adults seeking mental health services, and will yield promising results for improving outcomes of depression and anxiety in comparison to those in the control group. The pilot deign will address the following aims:
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
- Single (Investigator)
盲法说明
Participants will not be masked to their mobile app however investigators conducting data analysis will be blinded to which participants were assigned to which app
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 will be required to be Harvard students, 18 years old or older, own a smartphone with Wi-Fi or 3G/4G capabilities and have a triage appointment scheduled with Harvard Counseling and Mental Health. Those meeting basic eligibility requirements will also complete screening using the Patient Health Questionnaire - 9 and the Generalized Anxiety Disorder 7-item scale to determine final eligibility and obtain baseline assessment. A PHQ-9 score of 5 or greater, or a score of 2 or greater on PHQ item 10 (indicating that they felt disabled in their life because of their mood) or a GAD-7 score of 8 or greater will be required for enrollment.
排除标准
- •Those who score less than 5 on PHQ-9 or less than 8 on the GAD-7 during study screening will be excluded from the study and sent an automated message with information to contact HUHS CAMHS if their symptoms worsen and they need to be seen urgently.
- •*Participants with a PHQ-9 suicide item score of 1 or more will not be excluded from the study but will receive an automated message with information to call HUHS urgent care if they are feeling at risk of harm to themselves or others. Study staff will also notify CAMHS staff within one business day so that a member of staff can reach out to the participant and check in about scheduling an urgent care appointment.
结局指标
主要结局
Patient Health Questionnaire - 9 (PHQ-9)
时间窗: At two weeks after enrollment, participants will receive an email to complete the PHQ-9 and GAD-7, which will serve as the primary outcome measure of the study.
The PHQ-9 is a 9-question multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The Patient Health Questionnaire (PHQ-9) Scoring: Scoring: 0-3 Scale for each item; 0 Not at all; 3 Nearly every day The nine item version of the Patient Health Questionnaire (PHQ-9) was designed to facilitate the recognition and diagnosis of depression in primary care patients. It can be used to monitor change in symptoms over time and provides a depression severity index score as follows: 0-4 None 5-9 Mild 10 - 14 Moderate 15 - 19 Moderately Severe 20 - 27 Severe The recommended cut-off for the PHQ-9 severity index is a score of 9. Anyone who scores 10 or above can be considered to be suffering from clinically signicant symptoms of depression.
Generalized Anxiety Disorder 7-item scale (GAD-7)
时间窗: At two weeks after enrollment, participants will receive an email to complete the PHQ-9 and GAD-7, which will serve as the primary outcome measure of the study.
The GAD-7 is a 7 item instrument for screening and severity measuring of generalized anxiety disorder (GAD). Scoring: 0-3 Scale for each item; 0 Not at all; 3 Nearly every day The index scores are as follows: 0-4 None 5-10 Mild Anxiety 11 - 15 Moderate Anxiety 15 - 21 Severe Anxiety The recommended cut off for the GAD-7 severity index is a score of 7. Anyone who scores 8 or above can be considered to be suffering from clinically significant anxiety symptoms.
次要结局
- Multidimensional Scale of Perceived Social Support(Participants will receive this instrument at baseline, and at the 4 and 8-week endpoint.)
- Client Satisfaction Questionnaire (CSQ-8)(Participants will receive a survey to complete this questionnaire at the 8 week endpoint)
- Participant Experience Survey(Participants will receive a survey to complete this questionnaire at the 2, 4, 8 and 12 week endpoint)
- Secondary Process Outcome Survey(Participants will receive a survey to complete this questionnaire at the 4 and 8 week endpoint)
研究者
Leslie Tarver
Physician Researcher
Harvard University