First Episode Psychosis (FEP)EPI-CALNCT04007510
California Collaborative Network to Promote Data Driven Care and Improve Outcomes in Early Psychosis
A study testing EPI-CAL data network and Community DUP Assessment Tool in people with First Episode Psychosis (FEP), run by University of California, Davis at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 8 to 40 years
- Conditions the study is for
- First Episode Psychosis (FEP)
- What is being tested?
- EPI-CAL data network and Community DUP Assessment Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,329 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2019to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- FEP individuals, ages 12-30, who have experienced the onset of an affective (bipolar or major depression with psychotic features) or non-affective psychotic disorder (schizophrenia, schizoaffective, schizophreniform, brief psychotic, other specified or unspecified schizophrenia spectrum disorders) within the past 5 years and are receiving early psychosis services at one of the study sites.
- Family members/support persons, over age 18, of the participating FEP (or CHR) individuals are receiving early psychosis services at one of the study sites
- Early psychosis (EP) care providers (e.g. clinicians, physicians, nurses, support staff) who are providing care at one of the study sites.
- Additional stakeholders from the communities served by the study sites, including EP program and county administrators, state representatives, and local community groups as well as researchers and other experts in relevant domains.
- Clinical high risk (CHR) individuals, ages 12-30, who 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.
Who cannot join
- neurological illness or injury leading to psychotic symptoms
- reported diagnosis of intellectual disability or estimated IQ below 70 according to the Pennsylvania Computerized Neuropsychological Test Battery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Imaging Research Center
Sacramento, California, 95817
About this study
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.
Read the detailed description
A prolonged first episode of psychosis (FEP) without adequate treatment is the most consistent predictor of poor clinical and functional outcomes, poor health outcomes and significant economic burden. Team-based "coordinated specialty care" (CSC) for early psychosis (EP) has established effectiveness in promoting clinical and functional recovery. EP treatment programs have expanded rapidly with increased funding across the US without formal coordination of training or implementation. While EP programs share many features, the lack of state and national coordination and data infrastructure limits the capacity for large-scale evaluation or accelerated dissemination of best practices. Based on prior collaborations with 30 California (CA) EP programs and experiences using mobile health (MOBI mHealth) technology to measure individual outcomes in EP care, the UC Davis (UCD) team is uniquely poised to create EPI-CAL, a CA network that will contribute systematically collected outcomes data on 1329 FEP clients per year, from 6 community and 6 university EP clinics, to a national EP network supported by the NIMH EPINET program.
Building on the team's prior work evaluating CA EP programs, EPI-CAL programs will participate in a formative evaluation in Year 1 to define core EP clinical features, intervention targets, and outcomes needed to harmonize network input. A "core battery" based on current measures collected at the sites, the PhenX toolkit and expanded to cover all critical domains, will be installed across the network in Year 2. Core client outcomes and metrics of data use for treatment decisions will be collected using the custom MOBI mHealth data network at the client, program, and state level to allow easy data analysis, interpretation and dissemination. Training and ongoing monitoring will be provided at all EPI-CAL sites to ensure appropriate implementation. EPI-CAL will contribute de-identified data to the national coordinating hub. Using the RE-AIM implementation science framework, the investigators will systematically evaluate the impact of MOBI on EP programs across 5 dimensions: reach, efficacy, adoption, implementation, and maintenance.
To demonstrate the network's research capacity, in the R34 component of this application, the investigators propose to develop and validate a measure of the Duration of Untreated Psychosis (DUP) that is feasible for use in community settings and psychometrically sound. Although DUP is a significant predictor of both short-term CSC treatment response and long-term outcomes for FEP, no measure currently exists that has been rigorously validated and is feasible for use by community providers. The investigators will utilize stakeholder feedback (clients, family members, academic experts and CSC staff) to develop a tool with standardized DUP definitions that includes anchored assessment of psychosis onset and start of treatment. Developing such a tool will allow standardized assessment of this critical moderator of CSC outcomes across the entire EPINET.
FEP (and CHR) individuals receiving early psychosis treatment services at one of the participating sites will be invited to participate in all aspects of the study. Family members/ support persons will be asked to participate in tablet data collection and provide feedback via surveys, interviews and focus groups. EP providers will complete questionnaires and provide feedback via surveys, interviews and focus groups. Stakeholders (e.g. EP program and county administrators, support staff, and local community groups) will participate in focus groups and feedback interviews.
Aim 1: To create a sustainable CA EP network using a core battery of evidence-based measures.To address this aim, the investigators will test the following hypotheses: H1.1: 70% of eligible FEP participants, representative of the target population, and 50% of available family members across the network will enroll and complete baseline (Reach). Client-, provider- and program-level barriers to engagement will be identified through analyses of qualitative data (Reach). H1.2: Clinician use of MOBI over 12 months of care, as measured by MOBI, will be associated with reduced psychotic symptom severity for FEP at 12 months (Efficacy). H1.3: Clinician use of MOBI will be positively associated with reduction in psychotic symptom severity at 24 months and higher patient satisfaction with care (Maintenance).
Aim 2. To develop an integrated data network that provides real-time feedback to improve clinical care and program quality, and contribute de-identified data to the national coordinating hub. The investigators hypothesize that: H2.1: Compared to pre-MOBI, providers will report increased use of data to determine treatment choices after training and using MOBI for 6 months (Adoption); H2.2: Over 12 months, EP providers will use MOBI in direct care to FEP clients for at least 50% of completed assessments (Implementation). Client-, provider- and program-level barriers to implementation will be identified through analyses of qualitative data; H2.3: Exploratory analysis will examine level of clinician expertise and training needed to effectively implement clinician review of FEP participant outcome data using MOBI at 80% of available time points (Adoption).
Aim 3. To develop and validate a novel DUP measure for use in community settings (R34). The investigators hypothesize this new measure will show: H3.1: inter-rater reliability (IRR) between CSC providers and a MA-level assessor with an intra-class coefficient (ICC) of at least .80 for days from initial assessment to DUP start point, days from assessment to DUP end point, and days from start point to end point DUP (total DUP); H3.2: convergent validity, with ICCs of at least .80 between CSC providers and centralized study team assessors using the Symptom Onset in Schizophrenia Inventory (SOS) (reference standard); H3.3: Predictive validity, defined by significant relationships between shorter DUP and greater improvements in functioning and quality of life at 6 and 12 months; H3.4: Feasibility and acceptability to EP providers and clients, with a mean administration time of less than 40 minutes.
- Conditions
- First Episode Psychosis (FEP)
- Being tested
- EPI-CAL data network, Community DUP Assessment Tool
- Keywords
- Psychosis, first episode, clinical high risk, outcomes, mobile health, data driven care, learning healthcare network
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPI-CAL data networkCombination product
Also called mHealth App
This mobile, app-based platform was designed to: 1) enable outcomes data collection from clients and family members/support person who are receiving care at an early psychosis program, 2) summarize the data visually for clients and providers on a secure web-based dashboard, and 3) allow download of de-identified data for program or research analysis.
Community DUP Assessment ToolDiagnostic test
A tool will be developed to enable measurement of the duration of untreated psychosis (DUP) for FEP individuals based on 1) data other assessments that are typically completed during the intake process (e.g. SIPS, SCID) or 2) specific questions, prompts, a rating scale, and anchor points to enable rating of the DUP. Participants would have their DUP rated on the new tool and also complete a second assessment of DUP by research evaluators using the Symptom Onset in Schizophrenia Inventory (SOS) to determine reliability and validity of the new tool.
| Study group | Role | What they receive |
|---|---|---|
| EPI-CAL mHealth data network | Experimental | This arm of the study involves the use of the mobile health technology ("app") to measure outcomes within an early psychosis (EP) program. Receives: Combination Product: EPI-CAL data network |
| DUP Evaluation | Experimental | A subset of individuals will participate in interviews to validate a tool to determine the duration of untreated psychosis in community settings Receives: Diagnostic Test: Community DUP Assessment Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
Show adequate reach of enrollment using descriptive statistics showing 70% of eligible FEP participants, who are representative of the target population based on current program demographics, and 50% of their available family members, across the network were enrolled and complete baseline
Measured: end of study, maximum of 5 years
Colorado Symptom Index (CSI) - Symptom severity
Efficacy of measurement-based care, comparing adjusted mean differences in baseline to 12-month change in psychotic symptom severity on the Colorado Symptom Index (CSI), between groups defined by clinician metrics from mHealth app assessed during this 12-month period. The CSI is a 14-item, self-report scale designed to assess frequency of positive mood and cognitive symptoms. Each item is scored on a 0-4 Likert-style scale and added together to give a score between 0 and 56, with higher scores indicating greater emotional distress. Reduction in score over time is considered clinical improvement. Maintenance of measurement-based care, based on adjusted mean differences in baseline to 24-month change in psychotic symptom severity between groups defined by clinician metrics from mHealth app aggregated over the 6-, 12- and 18-month assessment period, with the primary analysis based on a composite indicator for any endorsement of "impact on treatment plan" across these three periods.
Measured: end of study, maximum of 5 years
Provider use of data in care
Compared to pre-implementation period, providers will report a change in the use of data to determine treatment choices after training and using the app for 6 months (Adoption). Adoption of data in care is measure by pre- and post-surveys of randomly sampled client sessions)
Measured: end of study, maximum of 5 years
Provider use of mHealth app
Over 12 months, EP providers will use mHealth app in direct care to FEP clients for at least 50% of completed assessments (Implementation) as measured by metrics gathered in mHealth app.
Measured: end of study, maximum of 5 years
DUP tool reliability
New DUP tool will show inter-rater reliability (IRR) between CSC providers and a MA-level assessor with an intra-class coefficient (ICC) of at least .80 for days from initial assessment to DUP start point, days from assessment to DUP end point, and days from start point to end point DUP (total DUP).
Measured: end of study, maximum of 5 years
DUP Tool convergent validity
New DUP tool will show convergent validity, with ICCs of at least .80 between CSC providers and centralized study team assessors using the Symptom Onset in Schizophrenia Inventory (SOS) (reference standard).
Measured: end of study, maximum of 5 years
DUP Tool predictive validity - Functioning
New DUP tool will show predictive validity, defined by significant relationships between shorter DUP and greater improvements in functioning (Global Social and Role Functioning scales) at 6 and 12 months - shown by regression coefficients between DUP and change from baseline to 6 and 12 months in functioning.
Measured: end of study, maximum of 5 years
DUP Tool predictive validity - Quality of Life
New DUP tool will show predictive validity, defined by significant relationships between shorter DUP and greater improvements in quality of life (Lehman Quality of Life scale) at 6 and 12 months - shown by regression coefficients between DUP and change from baseline to 6 and 12 months in quality of life.
Measured: end of study, maximum of 5 years
DUP Tool feasibility and Acceptability
Feasibility and acceptability to EP providers and clients, with a mean administration time of less than 40 minutes for the brief and full versions of the new DUP Tool
Measured: end of study, maximum of 5 years
Secondary outcomes (2)
Satisfaction with care
Patient rated satisfaction with EP care at end of study (Maintenance) as measured on the Client Satisfaction Questionnaire (CSQ-8). The CSQ-8 is an 8-item measurement that is designed to measure client satisfaction with services. Each item is scored on a 1-4 Likert-style scale and added together to give a score between 8 and 32, with higher scores indicating greater satisfaction with care.
Measured: end of study, maximum of 5 years
Provider level factors
Exploratory analysis will examine level of clinician expertise and training needed to effectively implement clinician review of FEP participant outcome data using MOBI at 80% of available time points (Adoption).
Measured: end of study, maximum of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start10 Sep 2019
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for First Episode Psychosis (FEP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,329 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Mental Health (NIMH), Washington University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04007510
- Sponsor's protocol ID
- 1403828
- Acronym
- EPI-CAL
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2019
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tryon VL, Nye KE, Savill M, Loewy R, Miles MJ, Tully LM, Padovani AJ, Tancredi DJ, Melnikow J, Ereshefsky S, Sharma N, McNamara AP, Kado-Walton M, Hakusui CK, Miller C, Nguyen KLH, Safdar M, Padilla VE, Smith L, Wilcox AB, Banks LM, Hayes SL, Pierce KM, Muro K, Shapiro DI, Bolden-Thompson KA, Botello RM, Grattan RE, Zhang Y, Hotz B, Dixon L, Carter CS, Niendam TA. The California collaborative network to promote data driven care and improve outcomes in early psychosis (EPI-CAL) project: rationale, background, design and methodology. BMC Psychiatry. 2024 Nov 14;24(1):800. doi: 10.1186/s12888-024-06245-6.
PubMed 39543502
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- California Collaborative Network to Promote Data Driven Care and Improve Outcomes in Early Psychosis
- ClinicalTrials.gov ID
- NCT04007510
- Acronym / sponsor ID
- EPI-CAL / 1403828
- Conditions
- First Episode Psychosis (FEP)
- Keywords
- Psychosis, first episode, clinical high risk, outcomes, mobile health, data driven care, learning healthcare network
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,329 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of California, San Francisco, National Institute of Mental Health (NIMH), Washington University School of Medicine
- Study start
- 10 Sep 2019 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A prolonged first episode of psychosis (FEP) without adequate treatment is the most consistent predictor of poor clinical and functional outcomes, poor health outcomes and significant economic burden. Team-based "coordinated specialty care" (CSC) for early psychosis (EP) has established effectiveness in promoting clinical and functional recovery. EP treatment programs have expanded rapidly with increased funding across the US without formal coordination of training or implementation. While EP programs share many features, the lack of state and national coordination and data infrastructure limits the capacity for large-scale evaluation or accelerated dissemination of best practices. Based on prior collaborations with 30 California (CA) EP programs and experiences using mobile health (MOBI mHealth) technology to measure individual outcomes in EP care, the UC Davis (UCD) team is uniquely poised to create EPI-CAL, a CA network that will contribute systematically collected outcomes data on 1329 FEP clients per year, from 6 community and 6 university EP clinics, to a national EP network supported by the NIMH EPINET program.
Building on the team's prior work evaluating CA EP programs, EPI-CAL programs will participate in a formative evaluation in Year 1 to define core EP clinical features, intervention targets, and outcomes needed to harmonize network input. A "core battery" based on current measures collected at the sites, the PhenX toolkit and expanded to cover all critical domains, will be installed across the network in Year 2. Core client outcomes and metrics of data use for treatment decisions will be collected using the custom MOBI mHealth data network at the client, program, and state level to allow easy data analysis, interpretation and dissemination. Training and ongoing monitoring will be provided at all EPI-CAL sites to ensure appropriate implementation. EPI-CAL will contribute de-identified data to the national coordinating hub. Using the RE-AIM implementation science framework, the investigators will systematically evaluate the impact of MOBI on EP programs across 5 dimensions: reach, efficacy, adoption, implementation, and maintenance.
To demonstrate the network's research capacity, in the R34 component of this application, the investigators propose to develop and validate a measure of the Duration of Untreated Psychosis (DUP) that is feasible for use in community settings and psychometrically sound. Although DUP is a significant predictor of both short-term CSC treatment response and long-term outcomes for FEP, no measure currently exists that has been rigorously validated and is feasible for use by community providers. The investigators will utilize stakeholder feedback (clients, family members, academic experts and CSC staff) to develop a tool with standardized DUP definitions that includes anchored assessment of psychosis onset and start of treatment. Developing such a tool will allow standardized assessment of this critical moderator of CSC outcomes across the entire EPINET.
FEP (and CHR) individuals receiving early psychosis treatment services at one of the participating sites will be invited to participate in all aspects of the study. Family members/ support persons will be asked to participate in tablet data collection and provide feedback via surveys, interviews and focus groups. EP providers will complete questionnaires and provide feedback via surveys, interviews and focus groups. Stakeholders (e.g. EP program and county administrators, support staff, and local community groups) will participate in focus groups and feedback interviews.
Aim 1: To create a sustainable CA EP network using a core battery of evidence-based measures.To address this aim, the investigators will test the following hypotheses: H1.1: 70% of eligible FEP participants, representative of the target population, and 50% of available family members across the network will enroll and complete baseline (Reach). Client-, provider- and program-level barriers to engagement will be identified through analyses of qualitative data (Reach). H1.2: Clinician use of MOBI over 12 months of care, as measured by MOBI, will be associated with reduced psychotic symptom severity for FEP at 12 months (Efficacy). H1.3: Clinician use of MOBI will be positively associated with reduction in psychotic symptom severity at 24 months and higher patient satisfaction with care (Maintenance).
Aim 2. To develop an integrated data network that provides real-time feedback to improve clinical care and program quality, and contribute de-identified data to the national coordinating hub. The investigators hypothesize that: H2.1: Compared to pre-MOBI, providers will report increased use of data to determine treatment choices after training and using MOBI for 6 months (Adoption); H2.2: Over 12 months, EP providers will use MOBI in direct care to FEP clients for at least 50% of completed assessments (Implementation). Client-, provider- and program-level barriers to implementation will be identified through analyses of qualitative data; H2.3: Exploratory analysis will examine level of clinician expertise and training needed to effectively implement clinician review of FEP participant outcome data using MOBI at 80% of available time points (Adoption).
Aim 3. To develop and validate a novel DUP measure for use in community settings (R34). The investigators hypothesize this new measure will show: H3.1: inter-rater reliability (IRR) between CSC providers and a MA-level assessor with an intra-class coefficient (ICC) of at least .80 for days from initial assessment to DUP start point, days from assessment to DUP end point, and days from start point to end point DUP (total DUP); H3.2: convergent validity, with ICCs of at least .80 between CSC providers and centralized study team assessors using the Symptom Onset in Schizophrenia Inventory (SOS) (reference standard); H3.3: Predictive validity, defined by significant relationships between shorter DUP and greater improvements in functioning and quality of life at 6 and 12 months; H3.4: Feasibility and acceptability to EP providers and clients, with a mean administration time of less than 40 minutes.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPI-CAL mHealth data network | Experimental | Combination Product: EPI-CAL data networkThis arm of the study involves the use of the mobile health technology ("app") to measure outcomes within an early psychosis (EP) program. |
| DUP Evaluation | Experimental | Diagnostic Test: Community DUP Assessment ToolA subset of individuals will participate in interviews to validate a tool to determine the duration of untreated psychosis in community settings |
Who may qualify
- Ages
- 8 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- FEP individuals, ages 12-30, who have experienced the onset of an affective (bipolar or major depression with psychotic features) or non-affective psychotic disorder (schizophrenia, schizoaffective, schizophreniform, brief psychotic, other specified or unspecified schizophrenia spectrum disorders) within the past 5 years and are receiving early psychosis services at one of the study sites.
- Family members/support persons, over age 18, of the participating FEP (or CHR) individuals are receiving early psychosis services at one of the study sites
- Early psychosis (EP) care providers (e.g. clinicians, physicians, nurses, support staff) who are providing care at one of the study sites.
- Additional stakeholders from the communities served by the study sites, including EP program and county administrators, state representatives, and local community groups as well as researchers and other experts in relevant domains.
- Clinical high risk (CHR) individuals, ages 12-30, who 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.
Key exclusion criteria (2 listed)
- neurological illness or injury leading to psychotic symptoms
- reported diagnosis of intellectual disability or estimated IQ below 70 according to the Pennsylvania Computerized Neuropsychological Test Battery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPI-CAL data networkAlso: mHealth AppThis mobile, app-based platform was designed to: 1) enable outcomes data collection from clients and family members/support person who are receiving care at an early psychosis program, 2) summarize the data visually for clients and providers on a secure web-based dashboard, and 3) allow download of de-identified data for program or research analysis. | Combination product | EPI-CAL mHealth data network |
| Community DUP Assessment ToolA tool will be developed to enable measurement of the duration of untreated psychosis (DUP) for FEP individuals based on 1) data other assessments that are typically completed during the intake process (e.g. SIPS, SCID) or 2) specific questions, prompts, a rating scale, and anchor points to enable rating of the DUP. Participants would have their DUP rated on the new tool and also complete a second assessment of DUP by research evaluators using the Symptom Onset in Schizophrenia Inventory (SOS) to determine reliability and validity of the new tool. | Diagnostic test | DUP Evaluation |
Primary outcome
Enrollment
Time frame: end of study, maximum of 5 years
Show adequate reach of enrollment using descriptive statistics showing 70% of eligible FEP participants, who are representative of the target population based on current program demographics, and 50% of their available family members, across the network were enrolled and complete baseline
Colorado Symptom Index (CSI) - Symptom severity
Time frame: end of study, maximum of 5 years
Efficacy of measurement-based care, comparing adjusted mean differences in baseline to 12-month change in psychotic symptom severity on the Colorado Symptom Index (CSI), between groups defined by clinician metrics from mHealth app assessed during this 12-month period. The CSI is a 14-item, self-report scale designed to assess frequency of positive mood and cognitive symptoms. Each item is scored on a 0-4 Likert-style scale and added together to give a score between 0 and 56, with higher scores indicating greater emotional distress. Reduction in score over time is considered clinical improvement. Maintenance of measurement-based care, based on adjusted mean differences in baseline to 24-month change in psychotic symptom severity between groups defined by clinician metrics from mHealth app aggregated over the 6-, 12- and 18-month assessment period, with the primary analysis based on a composite indicator for any endorsement of "impact on treatment plan" across these three periods.
Provider use of data in care
Time frame: end of study, maximum of 5 years
Compared to pre-implementation period, providers will report a change in the use of data to determine treatment choices after training and using the app for 6 months (Adoption). Adoption of data in care is measure by pre- and post-surveys of randomly sampled client sessions)
Provider use of mHealth app
Time frame: end of study, maximum of 5 years
Over 12 months, EP providers will use mHealth app in direct care to FEP clients for at least 50% of completed assessments (Implementation) as measured by metrics gathered in mHealth app.
DUP tool reliability
Time frame: end of study, maximum of 5 years
New DUP tool will show inter-rater reliability (IRR) between CSC providers and a MA-level assessor with an intra-class coefficient (ICC) of at least .80 for days from initial assessment to DUP start point, days from assessment to DUP end point, and days from start point to end point DUP (total DUP).
DUP Tool convergent validity
Time frame: end of study, maximum of 5 years
New DUP tool will show convergent validity, with ICCs of at least .80 between CSC providers and centralized study team assessors using the Symptom Onset in Schizophrenia Inventory (SOS) (reference standard).
DUP Tool predictive validity - Functioning
Time frame: end of study, maximum of 5 years
New DUP tool will show predictive validity, defined by significant relationships between shorter DUP and greater improvements in functioning (Global Social and Role Functioning scales) at 6 and 12 months - shown by regression coefficients between DUP and change from baseline to 6 and 12 months in functioning.
DUP Tool predictive validity - Quality of Life
Time frame: end of study, maximum of 5 years
New DUP tool will show predictive validity, defined by significant relationships between shorter DUP and greater improvements in quality of life (Lehman Quality of Life scale) at 6 and 12 months - shown by regression coefficients between DUP and change from baseline to 6 and 12 months in quality of life.
DUP Tool feasibility and Acceptability
Time frame: end of study, maximum of 5 years
Feasibility and acceptability to EP providers and clients, with a mean administration time of less than 40 minutes for the brief and full versions of the new DUP Tool
2 secondary outcomes
Satisfaction with care
Time frame: end of study, maximum of 5 years
Provider level factors
Time frame: end of study, maximum of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Derived from this study: PubMed 39543502Tryon VL, Nye KE, Savill M, Loewy R, Miles MJ, Tully LM, Padovani AJ, Tancredi DJ, Melnikow J, Ereshefsky S, Sharma N, McNamara AP, Kado-Walton M, Hakusui CK, Miller C, Nguyen KLH, Safdar M, Padilla VE, Smith L, Wilcox AB, Banks LM, Hayes SL, Pierce KM, Muro K, Shapiro DI, Bolden-Thompson KA, Botello RM, Grattan RE, Zhang Y, Hotz B, Dixon L, Carter CS, Niendam TA. The California collaborative network to promote data driven care and improve outcomes in early psychosis (EPI-CAL) project: rationale, background, design and methodology. BMC Psychiatry. 2024 Nov 14;24(1):800. doi: 10.1186/s12888-024-06245-6.
- Individual participant dataSharing planned: No
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Recruiting
Enhancing Cognitive and Work/School Outcomes in First Episode Psychosis Using Cognitive Self-Management Strategies
First Episode Psychosis (FEP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPI-CAL data network and Community DUP Assessment Tool in people with First Episode Psychosis (FEP), run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: end of study, maximum of 5 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04007510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.