Smartphone Applications Youth With Early Psychosis in Community Outpatient Settings

NCT03286595 | Completed

• 1 other identifier: 782574
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psychosis; Clinical High Risk for Psychosis

Keywords

early psychosis; clinical high risk; mobile health

Outcome Measures

Primary Outcomes (5)

• 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

• Acceptability/Satisfaction

  Acceptability will be measured with satisfaction survey ratings of mhealth app by patients and clinicians.

  18 months

• 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

• 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

• 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 Outcomes (3)

• Medication adherence

  18 months

• Therapeutic Alliance

  18 months

• Insight

  18 months

Study Arms (2)

Early Psychosis (EP)

EXPERIMENTAL

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.

Other: Mobi mHealth app

Clinicians

EXPERIMENTAL

Clinicians/treatment team members who are providing treatment services to the EP participants at one of the three early psychosis clinics.

Other: Mobi mHealth app

Interventions

Mobi mHealth app OTHER

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.

Clinicians; Early Psychosis (EP)

Eligibility Criteria

• Age: 13 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• IQ below 70
• history neurological disorders
• current substance abuse/dependence

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Imaging Research Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: September 18, 2017
• Study Start: August 19, 2015
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: September 18, 2017

Record last verified: 2017-09

Locations

US (1)