Smartphone Applications Youth With Early Psychosis in Community Outpatient Settings
Condition: Psychosis; Clinical High Risk for Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

Summary: 
      The project aims to test the utility of implementing a mobile health application ("mhealth
      app") in early psychosis care in the community outpatient setting and in the university
      medical center setting. We will enroll 60 individuals in the early stages of psychotic
      illness who are receiving care in two UC Davis affiliated community based early psychosis
      outpatient programs: the Aldea Child and Family Services SOAR Programs in Napa and Solano
      Counties (Napa SOAR, and Solano SOAR), as well as the UC Davis Early Psychosis Programs
      (EDAPT and SacEDAPT clinics). Early psychosis (EP) participants will include individuals at
      high risk for developing a psychotic illness (termed "clinical high risk" or CHR) and
      individuals within two years of their first psychotic episode (termed "first episode
      psychosis" or FEP). Over the course of five months, EP participants will use the app on their
      mobile device to complete daily surveys assessing mood, social interactions and medication
      adherence, and weekly surveys assessing clinical symptoms, sleep and medication adherence. EP
      participants will also complete clinical assessments with UC Davis research staff at the
      initial and final study appointments (baseline and five month timepoints). Clinicians working
      in the three early psychosis programs will also participate in the study. In their clinical
      role, they will interact with EP participants' app data via the Dashboard, a secure web-based
      portal, and provide feedback on the clinical utility of the data that is provided on the
      dashboard. EP participants and their clinicians will also provide feedback on the impact of
      the app on the therapeutic relationship.
    

Detailed description: 
      Although remission of psychotic symptoms following a patient's first episode of psychosis is
      achievable through pharmacological and psychosocial treatment, 50% of patients relapse within
      two years; 80% relapse within five. Relapse, defined as a recurrence of positive psychotic
      symptoms, is associated with cumulative increases in levels of psychotic symptoms following
      recovery, decreased social and community functioning, decreased quality of life, and
      increased hospitalizations. Given the negative impact on patients and their families, and the
      increasing cost of services as a function of relapse, development of effective relapse
      prevention strategies is imperative. Predictors of relapse amenable to treatment include: 1)
      clinical factors such as an exacerbation of clinical symptoms indicative of impending
      relapse; 2) treatment engagement factors such as medication adherence and therapeutic
      alliance; and 3) functioning factors such social impairments. Using mobile health technology
      in a community based outpatient clinic, we propose to specifically address these three types
      of relapse predictor variables.

      The mobile health application tested in this study provides a user interface and a provider
      interface. The user interface is the mobile application (i.e. the "app") that patients
      interact with via their smartphone. This is designed to be simple and easily accessible. The
      app gathers "active" data, i.e. self-report surveys, which the user is alerted to via
      notifications on their device. Active data are analyzed and summarized for each patient on
      the "Dashboard", a provider-facing web portal for accessing concise and relevant information
      about a patient. The Dashboard provides up-to-date information regarding a patient's survey
      responses. Providers then use this information to better inform treatment decisions.

      Specific aims and associated hypotheses are as follows:

      Aim 1: Determine the feasibility and acceptability of the mhealth app in a community based
      outpatient early psychosis population. Hypothesis a: EPs will show high utilization of the
      mhealth app and low dropout, as well as high satisfaction and endorsement of continued use of
      the app. Hypothesis b: Clinicians will report high satisfaction and endorsement of continued
      use of the app.

      Aim 2: Identify mhealth data related to key patient outcomes to inform calibration of patient
      status alerts. Hypothesis: Reductions in phone calls/text messages and/or increases in
      self-reported ratings of basic symptoms will predict psychotic symptom flares, increased
      clinic utilization, psychiatric ER visits and hospitalizations.

      Aim 3: Evaluate the effect of the mhealth app on medication adherence, therapeutic alliance,
      and insight. Hypothesis a: After five months of app use, patients will report improved
      medication adherence, therapeutic alliance with their clinicians, and insight into their
      illness. Hypothesis b: After five months of use, clinicians will report improved therapeutic
      alliance with their patients.
    

Intervention name(s): Mobi mHealth app
Intervention type(s): Other
Intervention description(s): Mobile application (i.e. the "app") that patients interact with via their smartphone to collect daily and weekly survey information. Data is visualized on a clinician-facing Dashboard, which can be used to inform treatment.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: early psychosis; clinical high risk; mobile health