Smartphone Applications Youth With Early Psychosis in Community Outpatient Settings

Psychosis Clinical Trial

— BHCOEMobi  

Official title:

Smartphone Applications For Use in Youth With Early Psychosis in Community Outpatient Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03286595
• Other study ID #: 782574
• Status: Completed
• Phase: N/A
• First received: July 24, 2017
• Last updated: September 13, 2017
• Start date: August 19, 2015
• Est. completion date: December 31, 2016

Study information

• Verified date: September 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 30 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria for EP and CHR participants are: age 13-30 years, English fluency, and receiving clinical care at one of three UC Davis affiliated early psychosis clinics in the Northern California region: 1) UC Davis Early Psychosis Program (SacEDAPT & EDAPT clinics); 2) Aldea Solano SOAR Program; 3) Aldea Napa SOAR program.

• 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.

• FEP participants will be ascertained within 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.

Exclusion Criteria:

• IQ below 70

• history neurological disorders

• current substance abuse/dependence

Related Conditions & MeSH terms

• Clinical High Risk for Psychosis
• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Other:
• Mobi mHealth app
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.

Locations

Country	Name	City	State
United States	UC Davis Imaging Research Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Feasibility will be measured by utilization of the application (i.e. number of enrolled and active participants versus total patient population invited).	18 months
Primary	Acceptability/Satisfaction	Acceptability will be measured with satisfaction survey ratings of mhealth app by patients and clinicians.	18 months
Primary	Brief Psychiatric Rating Scale (BPRS)	a 24-item semi-structured clinical interview rating symptom severity at ascertainment across four domains: positive symptoms, negative symptoms, agitation/mania, and depression/anxiety.	18 months
Primary	Critical incidents	Includes information from patient chart: increased clinic contact, psychiatric ER visits or hospitalizations, and progression from a high risk state to first episode psychosis.	18 months
Primary	The Clinical Global Impression-Schizophrenia scale (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.	18 months
Secondary	Medication adherence	The MARS (Thompson et al., 2000) is a 10-item self-report questionnaire assessing medication taking behavior, attitudes to medication, and side effects.	18 months
Secondary	Therapeutic Alliance	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).	18 months
Secondary	Insight	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.	18 months