Data-Driven Care Approach for Psychosis

(EPI-CAL Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

1329 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed project seeks to create a California early psychosis network using a core assessment battery of valid, low burden measures and mHealth technology platform to collect client-level data, visualize data via clinician dashboard for treatment planning, and integrate across clinics to provide de-identified data to the national coordinating hub. Research capacity for the network will be tested via development and validation of a measure of the Duration of Untreated Psychosis (DUP) that is feasible for use in community settings. The proposed California network will contribute systematically collected outcomes data on over 100 FEP clients per year, from 12 community and university EP clinics, to enhance the development of a national EP network, supported by the NIMH EPINET program.

Eligibility Criteria

This trial is for young people aged 12-30 who've had their first episode of psychosis within the last 5 years and are getting treatment at participating sites. It's also open to family members over age 18, care providers, community stakeholders, and individuals at high risk but without a full-blown psychosis.

Inclusion Criteria

I am aged 12-30 and was diagnosed with a psychotic disorder in the last 5 years.

I am aged 12-30, at high risk for psychosis, with symptoms or a family history, and have seen a drop in my daily functioning.

I am a care provider for early psychosis at a study site.

Exclusion Criteria

I have had a brain condition or injury that caused severe mental health symptoms.

Reported diagnosis of intellectual disability or estimated IQ below 70 according to the Pennsylvania Computerized Neuropsychological Test Battery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Formative Evaluation

EPI-CAL programs participate in a formative evaluation to define core EP clinical features, intervention targets, and outcomes

1 year

Implementation and Data Collection

Core client outcomes and metrics of data use for treatment decisions are collected using the MOBI mHealth data network

12 months

Ongoing data collection and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6-12 months

Treatment Details

Interventions

• Community DUP Assessment Tool
• EPI-CAL data network

Trial Overview The study aims to create a network in California that uses mobile health tech and clinician dashboards to track patient data on early psychosis. They're testing how well they can collect this data across clinics and developing a tool to measure untreated psychosis duration.

Participant Groups

Group I: EPI-CAL mHealth data network Experimental Treatment 1 Intervention

This arm of the study involves the use of the mobile health technology ("app") to measure outcomes within an early psychosis (EP) program.

Group II: DUP Evaluation Experimental Treatment 1 Intervention

A subset of individuals will participate in interviews to validate a tool to determine the duration of untreated psychosis in community settings

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+