<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03286595</url>
  </required_header>
  <id_info>
    <org_study_id>782574</org_study_id>
    <nct_id>NCT03286595</nct_id>
  </id_info>
  <brief_title>Smartphone Applications Youth With Early Psychosis in Community Outpatient Settings</brief_title>
  <acronym>BHCOEMobi</acronym>
  <official_title>Smartphone Applications For Use in Youth With Early Psychosis in Community Outpatient Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The project aims to test the utility of implementing a mobile health application (&quot;mhealth&#xD;
      app&quot;) in early psychosis care in the community outpatient setting and in the university&#xD;
      medical center setting. We will enroll 60 individuals in the early stages of psychotic&#xD;
      illness who are receiving care in two UC Davis affiliated community based early psychosis&#xD;
      outpatient programs: the Aldea Child and Family Services SOAR Programs in Napa and Solano&#xD;
      Counties (Napa SOAR, and Solano SOAR), as well as the UC Davis Early Psychosis Programs&#xD;
      (EDAPT and SacEDAPT clinics). Early psychosis (EP) participants will include individuals at&#xD;
      high risk for developing a psychotic illness (termed &quot;clinical high risk&quot; or CHR) and&#xD;
      individuals within two years of their first psychotic episode (termed &quot;first episode&#xD;
      psychosis&quot; or FEP). Over the course of five months, EP participants will use the app on their&#xD;
      mobile device to complete daily surveys assessing mood, social interactions and medication&#xD;
      adherence, and weekly surveys assessing clinical symptoms, sleep and medication adherence. EP&#xD;
      participants will also complete clinical assessments with UC Davis research staff at the&#xD;
      initial and final study appointments (baseline and five month timepoints). Clinicians working&#xD;
      in the three early psychosis programs will also participate in the study. In their clinical&#xD;
      role, they will interact with EP participants' app data via the Dashboard, a secure web-based&#xD;
      portal, and provide feedback on the clinical utility of the data that is provided on the&#xD;
      dashboard. EP participants and their clinicians will also provide feedback on the impact of&#xD;
      the app on the therapeutic relationship.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although remission of psychotic symptoms following a patient's first episode of psychosis is&#xD;
      achievable through pharmacological and psychosocial treatment, 50% of patients relapse within&#xD;
      two years; 80% relapse within five. Relapse, defined as a recurrence of positive psychotic&#xD;
      symptoms, is associated with cumulative increases in levels of psychotic symptoms following&#xD;
      recovery, decreased social and community functioning, decreased quality of life, and&#xD;
      increased hospitalizations. Given the negative impact on patients and their families, and the&#xD;
      increasing cost of services as a function of relapse, development of effective relapse&#xD;
      prevention strategies is imperative. Predictors of relapse amenable to treatment include: 1)&#xD;
      clinical factors such as an exacerbation of clinical symptoms indicative of impending&#xD;
      relapse; 2) treatment engagement factors such as medication adherence and therapeutic&#xD;
      alliance; and 3) functioning factors such social impairments. Using mobile health technology&#xD;
      in a community based outpatient clinic, we propose to specifically address these three types&#xD;
      of relapse predictor variables.&#xD;
&#xD;
      The mobile health application tested in this study provides a user interface and a provider&#xD;
      interface. The user interface is the mobile application (i.e. the &quot;app&quot;) that patients&#xD;
      interact with via their smartphone. This is designed to be simple and easily accessible. The&#xD;
      app gathers &quot;active&quot; data, i.e. self-report surveys, which the user is alerted to via&#xD;
      notifications on their device. Active data are analyzed and summarized for each patient on&#xD;
      the &quot;Dashboard&quot;, a provider-facing web portal for accessing concise and relevant information&#xD;
      about a patient. The Dashboard provides up-to-date information regarding a patient's survey&#xD;
      responses. Providers then use this information to better inform treatment decisions.&#xD;
&#xD;
      Specific aims and associated hypotheses are as follows:&#xD;
&#xD;
      Aim 1: Determine the feasibility and acceptability of the mhealth app in a community based&#xD;
      outpatient early psychosis population. Hypothesis a: EPs will show high utilization of the&#xD;
      mhealth app and low dropout, as well as high satisfaction and endorsement of continued use of&#xD;
      the app. Hypothesis b: Clinicians will report high satisfaction and endorsement of continued&#xD;
      use of the app.&#xD;
&#xD;
      Aim 2: Identify mhealth data related to key patient outcomes to inform calibration of patient&#xD;
      status alerts. Hypothesis: Reductions in phone calls/text messages and/or increases in&#xD;
      self-reported ratings of basic symptoms will predict psychotic symptom flares, increased&#xD;
      clinic utilization, psychiatric ER visits and hospitalizations.&#xD;
&#xD;
      Aim 3: Evaluate the effect of the mhealth app on medication adherence, therapeutic alliance,&#xD;
      and insight. Hypothesis a: After five months of app use, patients will report improved&#xD;
      medication adherence, therapeutic alliance with their clinicians, and insight into their&#xD;
      illness. Hypothesis b: After five months of use, clinicians will report improved therapeutic&#xD;
      alliance with their patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 19, 2015</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility</measure>
    <time_frame>18 months</time_frame>
    <description>Feasibility will be measured by utilization of the application (i.e. number of enrolled and active participants versus total patient population invited).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability/Satisfaction</measure>
    <time_frame>18 months</time_frame>
    <description>Acceptability will be measured with satisfaction survey ratings of mhealth app by patients and clinicians.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Brief Psychiatric Rating Scale (BPRS)</measure>
    <time_frame>18 months</time_frame>
    <description>a 24-item semi-structured clinical interview rating symptom severity at ascertainment across four domains: positive symptoms, negative symptoms, agitation/mania, and depression/anxiety.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Critical incidents</measure>
    <time_frame>18 months</time_frame>
    <description>Includes information from patient chart: increased clinic contact, psychiatric ER visits or hospitalizations, and progression from a high risk state to first episode psychosis.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Clinical Global Impression-Schizophrenia scale (Haro et al., 2003)</measure>
    <time_frame>18 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>18 months</time_frame>
    <description>The MARS (Thompson et al., 2000) is a 10-item self-report questionnaire assessing medication taking behavior, attitudes to medication, and side effects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Therapeutic Alliance</measure>
    <time_frame>18 months</time_frame>
    <description>Therapeutic alliance will be assessed with the STAR (Mcguire-Snieckus et al., 2007), a 12-item questionnaire with patient and clinician versions assessing positive collaboration and positive clinician input (both versions), non-supportive input (patient version), and emotional difficulties (clinician version).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Insight</measure>
    <time_frame>18 months</time_frame>
    <description>Patient's insight into their illness will be assessed using the IS (Birchwood et al., 1994), an 8-item self-report questionnaire assessing awareness of illness, need for treatment, and attribution of symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Psychosis</condition>
  <condition>Clinical High Risk for Psychosis</condition>
  <arm_group>
    <arm_group_label>Early Psychosis (EP)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EP participants will be individuals who are either a) at clinical high risk (CHR) for developing psychosis and/or bipolar disorder, or b) First Episode Psychosis (FEP) participants meeting criteria for schizophreniform disorder, schizophrenia, schizoaffective disorder or another psychotic, non-schizophrenia diagnosis including those with bipolar disorder.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinicians</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinicians/treatment team members who are providing treatment services to the EP participants at one of the three early psychosis clinics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mobi mHealth app</intervention_name>
    <description>Mobile application (i.e. the &quot;app&quot;) 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.</description>
    <arm_group_label>Clinicians</arm_group_label>
    <arm_group_label>Early Psychosis (EP)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion criteria for EP and CHR participants are: age 13-30 years, English fluency,&#xD;
             and receiving clinical care at one of three UC Davis affiliated early psychosis&#xD;
             clinics in the Northern California region: 1) UC Davis Early Psychosis Program&#xD;
             (SacEDAPT &amp; EDAPT clinics); 2) Aldea Solano SOAR Program; 3) Aldea Napa SOAR program.&#xD;
&#xD;
          -  CHR participants will have no history of psychosis and will demonstrate attenuated&#xD;
             psychotic symptoms consistent with the Structured Interview for Prodromal Syndromes&#xD;
             (SIPS), or genetic risk (first-degree relative with psychosis) in conjunction with a&#xD;
             substantial drop in functioning over the past year.&#xD;
&#xD;
          -  FEP participants will be ascertained within three years or less from illness onset and&#xD;
             have diagnoses of affective (i.e. bipolar) and non-affective psychosis (i.e.&#xD;
             schizophrenia) according to DSM-IV criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  IQ below 70&#xD;
&#xD;
          -  history neurological disorders&#xD;
&#xD;
          -  current substance abuse/dependence&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>UC Davis Imaging Research Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 13, 2017</last_update_submitted>
  <last_update_submitted_qc>September 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>early psychosis</keyword>
  <keyword>clinical high risk</keyword>
  <keyword>mobile health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03286595
org study id: 782574
nct id: NCT03286595
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Feasibility
time frame: 18 months
description: Feasibility will be measured by utilization of the application (i.e. number of enrolled and active participants versus total patient population invited).
measure: Acceptability/Satisfaction
time frame: 18 months
description: Acceptability will be measured with satisfaction survey ratings of mhealth app by patients and clinicians.
measure: Brief Psychiatric Rating Scale (BPRS)
time frame: 18 months
description: a 24-item semi-structured clinical interview rating symptom severity at ascertainment across four domains: positive symptoms, negative symptoms, agitation/mania, and depression/anxiety.
measure: Critical incidents
time frame: 18 months
description: Includes information from patient chart: increased clinic contact, psychiatric ER visits or hospitalizations, and progression from a high risk state to first episode psychosis.
measure: The Clinical Global Impression-Schizophrenia scale (Haro et al., 2003)
time frame: 18 months
description: 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.
measure: Medication adherence
time frame: 18 months
description: The MARS (Thompson et al., 2000) is a 10-item self-report questionnaire assessing medication taking behavior, attitudes to medication, and side effects.
measure: Therapeutic Alliance
time frame: 18 months
description: Therapeutic alliance will be assessed with the STAR (Mcguire-Snieckus et al., 2007), a 12-item questionnaire with patient and clinician versions assessing positive collaboration and positive clinician input (both versions), non-supportive input (patient version), and emotional difficulties (clinician version).
measure: Insight
time frame: 18 months
description: Patient's insight into their illness will be assessed using the IS (Birchwood et al., 1994), an 8-item self-report questionnaire assessing awareness of illness, need for treatment, and attribution of symptoms.
arm group label: Early Psychosis (EP)
arm group type: Experimental
description: EP participants will be individuals who are either a) at clinical high risk (CHR) for developing psychosis and/or bipolar disorder, or b) First Episode Psychosis (FEP) participants meeting criteria for schizophreniform disorder, schizophrenia, schizoaffective disorder or another psychotic, non-schizophrenia diagnosis including those with bipolar disorder.
arm group label: Clinicians
arm group type: Experimental
description: Clinicians/treatment team members who are providing treatment services to the EP participants at one of the three early psychosis clinics.
intervention type: Other
intervention name: Mobi mHealth app
description: 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.
arm group label: Clinicians
arm group label: Early Psychosis (EP)
criteria: 
gender: All
minimum age: 13 Years
maximum age: 30 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Psychotic Disorders
mesh term: Mental Disorders
sharing ipd: Undecided