Data-Driven Care Approach for Psychosis

(EPI-CAL Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Neurological illness, Intellectual disability, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for individuals experiencing early psychosis by using technology to gather and analyze data. Participants will test a new mobile app designed to track treatment outcomes and help develop the Community DUP Assessment Tool, which measures how long psychosis goes untreated. Those who have experienced psychotic symptoms, such as schizophrenia or bipolar disorder with psychotic features, in the past five years and are receiving early psychosis services may be suitable candidates. The goal is to build a supportive network using the EPI-CAL data network for better treatment planning and understanding of psychosis. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance early psychosis care.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this data network and assessment tool are safe for use in early psychosis care?

Research shows that the EPI-CAL mHealth data network gathers information in early psychosis care to improve treatment outcomes. Both users and healthcare providers report positive experiences with it. No reports of serious side effects indicate it is well-tolerated.

The Community DUP Assessment Tool relies on proven methods for early psychosis detection. Testing has confirmed its accuracy and ease of use. Again, no reports of harmful effects suggest it is safe for community settings.

Overall, current information suggests both the EPI-CAL mHealth network and the Community DUP Assessment Tool are safe. They are designed to collect data and enhance care without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Data-Driven Care Approach for Psychosis because it introduces innovative methods to tackle early psychosis. Unlike traditional treatments that rely heavily on medication and psychotherapy, this approach uses the EPI-CAL mHealth data network, a mobile health technology, to actively monitor and measure outcomes, providing real-time data to enhance treatment precision. Additionally, the Community DUP Assessment Tool aims to better understand and reduce the duration of untreated psychosis through community-based interviews, potentially leading to earlier interventions. These tools could revolutionize how we approach psychosis by focusing on timely and personalized care.

What evidence suggests that this trial's treatments could be effective for early psychosis?

In this trial, the EPI-CAL mHealth data network forms one of the study arms and is part of a system designed to enhance early psychosis treatment. This system employs an app to track patient progress, which can help standardize care and improve the quality of psychosis programs. Initial findings suggest that technology in these settings can personalize treatment for each patient.

The Community DUP Assessment Tool constitutes another arm of the study. Research has shown it can accurately measure the duration of untreated psychosis. Shorter periods of untreated psychosis correlate with better long-term outcomes for patients, such as improved social skills and overall functioning. This tool helps identify and address untreated psychosis sooner, potentially leading to better recovery chances. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0920996424000689

The effectiveness of public health interventions, initiatives ... Not defined. Royal Park Multidiagnostic Instrument for Psychosis (RPMIP), 52 days, 30 days ... Quality Assessment Tool for Quantitative Studies. (2003). Google ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11140870/

The diagnostic accuracy of screening for psychosis ... This tool can assess both full psychosis and clinical high risk for psychosis ... The tool is the first step in a two-step procedure, where individuals who ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04007510

California Collaborative Network to Promote Data Driven ... New DUP tool will show predictive validity, defined by significant relationships between shorter DUP and greater improvements in functioning (Global Social and ...

4. nri-inc.org nri-inc.org/media/1567/nri_measuring_dup_csc.pdf

Measuring the Duration of Untreated Psychosis Within First ... Although the timeline tool was developed to be used with the DUP definition provided by Melle and colleagues (2004), it can be used with any definition, thus ...

5. bhsoac.ca.gov bhsoac.ca.gov/sites/default/files/UCD%20MHSA%20Deliverable%206_DUP_DUMI_5-1-17_revision.pdf

UC Davis Pilot & Statewide Method Development Analyzed the results of the stakeholder meeting, using these results to inform the development of an early psychosis program interview protocol and tool. 3 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9226538/

Screening for Early Emerging Mental Experiences (SEE ME) The tool should have established validity for eliciting psychotic-spectrum experiences, be easily scored, and have thresholds and/or norms for diverse ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10962362/

Identification of Psychosis Risk and Diagnosis of First-Episode ... Tools for Diagnosing First-Episode Psychosis and Psychotic-Spectrum Disorders. Psychosis-risk assessment tools (e.g., SIPS, CAARMS) are useful ...

8. easacommunity.org easacommunity.org/wp-content/uploads/2024/05/Psychosis-for-Primary-Care.pdf

Psychosis-for-Primary-Care.pdf A good history and using tools like the. Psychosis Questionnaire Brief (PQB) can assist in early detection and linking to coordinated specialty care. Visit www.

9. researchgate.net researchgate.net/figure/Predicted-Outcomes-under-each-DUP_fig1_337377029

Predicted Outcomes under each DUP The impact of initiatives aimed at reducing time in untreated psychosis during early-stage schizophrenia will be unknown for many years.

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/eip.12395

Symposia - 2016 - Early Intervention in Psychiatry Conclusions: Reliable tools now exist to assess quality and access to early psychosis services and support implementation. Talk 2. Cost- ...