Using Mobile Technology To Detect Early Warning Signs of Mental Health Challenges and Enhance Treatment Delivery For Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Critical Incidents
研究概览
简要总结
This project tests the feasibility of implementing a smartphone application - Ginger.io - in the UC Davis Early Psychosis Program, and investigates whether mobile health technology can improve treatment delivery and outcomes in individuals with early psychosis. Ginger.io is a smartphone application that utilizes methods of passive data collection (i.e. data gathered without active interaction/contribution from the user) to gather communication, movement, and interaction data from smartphone devices to model individuals' social, physical, and mental health. These models are used to infer health-related outcomes and could inform treatment. By implementing the Ginger.io application in the UC Davis Early Psychosis Program with an integrated clinical and research infrastructure, the investigators will be able to quickly determine its feasibility for use in early psychosis populations, while simultaneously developing its ability to systematically capture aspects of relapse and recovery that are unique to this patient population.
Objectives: This project has three principle objectives related to early psychosis care: 1) improve treatment delivery, 2) improve patient outcomes, and 3) lower treatment costs. The project will target individuals in the early stages of psychotic illness, including individuals at high risk for developing a psychotic illness (termed "clinical high risk" or CHR) and individuals within three years of their first psychotic episode (termed "first episode psychosis" or FEP). The early stages of psychotic illness represent a critical period for intervention; early identification of clinical deterioration and subsequent targeted intervention is crucial for rapid remission of symptoms and reduced relapse rates. However, without the information necessary to identify patients in need of such intervention, providers are limited in their ability to respond rapidly. Within the UCD Early Psychosis Program, a mobile health application such as Ginger.io has the potential to equip the providers and caregivers with valuable insight into a patient's status in real-time without the burden of increased appointments and intrusive monitoring, allowing the identification of early psychosis patients most in need of outreach, and routing of treatment resources to the right patients at the right time.
详细描述
The project comprises two phases. In both phases, patients will use the Ginger.io app on their mobile device to complete daily surveys assessing mood and social interactions, and weekly surveys assessing symptoms. Patients will also complete monthly gold-standard clinical interviews at the UC Davis Early Psychosis Program. Once enrolled, the investigators will ask patients to participate for the duration of the study, a total of 14 months across Phase I and II.
Phase I involves the collection of pilot data to assess feasibility and conduct exploratory analyses. Participants will include individuals in the earliest stages of psychosis (CHR and FEP). The investigators will recruit 60 participants to allow for 15% dropout, aiming to obtain complete data on 50 participants. Given the emphasis on feasibility and acceptability in Phase I, research staff will monitor patient Dashboards daily and provide clinicians with weekly summaries for each patient. Clinicians and patients will provide ratings on satisfaction and effect of Ginger.io on treatment at the end of Phase I.
Specific aims for Phase I are as follows:
Specific Aim 1: Determine the feasibility and acceptability of Ginger.io in an early psychosis population.
Feasibility will be measured by utilization of the application (i.e. number of enrolled and active participants versus total patient population invited). Acceptability will be measured with satisfaction survey ratings of Ginger.io by patients and clinicians. Analysis will include summary statistics reporting utilization rates and satisfaction ratings. The investigators hypothesize high utilization of Ginger.io and low dropout, as well as high satisfaction and endorsement of continued use of Ginger.io.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages 13-30, English fluency
排除标准
- •IQ Below 70, history of neurological disorders, or current substance abuse/dependence.
研究组 & 干预措施
Clinical high risk (CHR)
Subjects at clinical high risk (CHR) for psychosis and/or bipolar disorder, aged 13-30 years. CHR participants will have no history of psychosis and will demonstrate attenuated psychotic symptoms consistent with the Structured Interview for Prodromal Syndromes (SIPS), or genetic risk (first-degree relative with psychosis) in conjunction with a substantial drop in functioning over the past year. Assigned Mobile health application - Ginger.io
干预措施: Mobile health application - Ginger.io (Other)
First Episode Psychosis (FEP)
First Episode Psychosis (FEP) subjects aged 13-30 meeting criteria for schizophreniform disorder, schizophrenia, schizoaffective disorder or another psychotic, non-schizophrenia diagnosis including those with bipolar disorder. FEP participants will be ascertained three years or less from illness onset and have diagnoses of affective (i.e. bipolar) and non-affective psychosis (i.e. schizophrenia) according to DSM-IV criteria. Assigned Mobile health application - Ginger.io
干预措施: Mobile health application - Ginger.io (Other)
Healthy Controls (HC)
Healthy individuals with no current/past axis I disorders according to DSM-IV criteria and no first-degree relative with a psychotic disorder. Assigned Mobile health application - Ginger.io
干预措施: Mobile health application - Ginger.io (Other)
结局指标
主要结局
Critical Incidents
时间窗: through study completion, maximum of 18 months
Count of clinic contacts, psychiatric ER visits or hospitalizations, and progression from a high risk state to first episode psychosis.
Global Functioning Scale: Role
时间窗: through study completion, maximum of 18 months
Global Functioning Scale: Role provides ratings of functioning in social and role domains, respectively, on a 10-point Likert scale.
Acceptability of the Ginger.io app
时间窗: 6 months
Measured with satisfaction survey ratings of Ginger.io by patients and clinicians.
Global Assessment of Functioning
时间窗: through study completion, maximum of 18 months
The GAF is a numeric scale (0 through 100) that provides a rating of an individual's social, occupation, and psychological functioning.
Feasibility of using the Ginger.io app
时间窗: end of study, maximum of 18 months
measured by number of enrolled and active participants versus total patient population invited
Global Functioning Scale:Social
时间窗: through study completion, maximum of 18 months
Global Functioning Scale: Social provides ratings of functioning in social and role domains, respectively, on a 10-point Likert scale.
CGI
时间窗: through study completion, maximum of 18 months
The CGI (Haro et al., 2003) is a brief 12-item scale assessing illness severity and degree of improvement over follow-up that is appropriate for use in clinical or research settings.
Brief Psychiatric Rating Scale (BPRS)
时间窗: through study completion, maximum of 18 months
Brief Psychiatric Rating Scale (BPRS) is a 24-item semi-structured clinical interview rating symptom severity at ascertainment across four domains: positive symptoms, negative symptoms, agitation/mania, and depression/anxiety.
次要结局
- Clinically relevant patient alerts(through study completion, maximum of 18 months)
- Medication Adherence (MARS)(through study completion, maximum of 18 months)
- Therapeutic Alliance(through study completion, maximum of 18 months)
- Insight(through study completion, maximum of 18 months)
- Cost of Care(through study completion, maximum of 18 months)