Clinical trial NCT05509998: Reducing the Duration of Untreated Psychosis in the United States: The Impact of Screening and Systematic Communication
Official title: Early Stage Identification and Engagement to Reduce the Duration of Untreated Psychosis: Evaluating the Impact of Screening and Systematic Communication
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: First Episode Psychosis (FEP)
Clinical High Risk for Psychosis (CHR)
Keywords: Duration of Untreated Psychosis (DUP)
Screening
Communication
First Episode Psychosis (FEP)
Clinical High Risk for Psychosis (CHR)
Coordinated Specialty Care
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-08-22
Enrollment: 912
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedge Cluster Randomized Controlled Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this project is to investigate whether a systematic screening approach enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych) can reduce Duration of Untreated Psychosis (DUP) by facilitating early identification of first episode psychosis (FEP) cases, rapid referral to specialty care and engagement in treatment. The study team will use a stepped-wedge cluster randomized controlled trial design to compare a systematic screening and communication method (SCM) to systematic screening method (SM) to evaluate whether SCM substantially reduces DUP. The study team hypothesize that: (1) SCM will result in a higher number of individuals initiating specialty services compared to SM; (2) The mean DUP of FEP individuals in SCM condition will be lower than the mean DUP of FEP individuals in SM condition, due to the reduced time to initiate FEP services. We will also conduct a qualitative study to examine implementation barriers and facilitators of SCM.

Detailed description: Studies find a substantial delay between the onset of psychosis and the initiation of specialty treatment for first episode psychosis (FEP), with the duration of untreated psychosis (DUP) typically over one year in the U.S. Better strategies are needed to improve identification of individuals with FEP and to rapidly engage them in Coordinated Specialty Care (CSC) aimed at restoring functioning. This study will investigate whether a U.S. adaptation of a successful detection approach from the Netherlands enhanced by an innovative model of communicating information about psychosis and treatment options to patients and families (ComPsych), can reduce DUP. Researchers in the Netherlands compared screening of a consecutive help-seeking population entering mental health services to clinician referral from mental health clinics and found that screening captured significantly more individuals at clinical high risk for psychosis (CHR) and with FEP. Based on the Dutch model, within the Mount Sinai Health System in New York, the study team has piloted and established the feasibility of screening help-seeking youth entering mental health services with the aim of improving early identification of FEP cases and rapid referral to specialty care (Early Stage Identification and Engagement to Reduce DUP study (EaSIE), supported by NIMH R34). Individuals entering services are screened with the Prodromal Questionnaire-Brief Version (PQ-B). Those who screen positive are assessed by Structured Interview for Psychosis Risk Syndromes (SIPS) and referred to stage-specific specialty care (FEP or CHR services). To facilitate service engagement the study team developed, piloted, and established feasibility of the ComPsych model, a standardized training program for clinicians in delivering information about schizophrenia, psychosis and CHR to patients and families. The ComPsych model was developed based on qualitative studies with multiple stakeholders, which have shown that family involvement and clear communication about diagnosis are critical components to successful engagement in treatment and adherence to treatment recommendations. ComPsych aims to convey sensitive information in a way that promotes understanding, empathy, and a sense of ongoing support.

The objective of this project is to investigate whether a systematic screening approach enhanced by ComPsych can reduce Duration of Untreated Psychosis (DUP) by facilitating early identification of first episode psychosis (FEP) cases, rapid referral to specialty care and engagement in treatment. This study will use a Hybrid Type 1 randomized controlled trial design (RCT) to test the effectiveness of SCM vs SM and to examine multi-level implementation factors that can inform the identification of implementation strategies for future deployment of SCM in routine practice. This study team will use a stepped-wedge cluster RCT design to compare SCM to SM to evaluate whether SCM substantially reduces DUP. The study hypotheses are: (1) SCM will result in a higher number of individuals initiating specialty services compared to SM; (2) The mean DUP of FEP individuals in SCM condition will be lower than the mean DUP of FEP individuals in SM condition, due to the reduced time to initiate FEP services; (3) ComPsych targets (understanding of psychosis, stigma, attitudes about treatment) will mediate the impact of SCM on DUP. The study team will also conduct a multi-level qualitative implementation study informed by the Consolidated Framework for Implementation Research (CFIR) to first examine implementation barriers and facilitators and then apply the Expert Recommendations for Implementing Change (ERIC) taxonomy of implementation strategies to these findings to help select potential implementation strategies for SCM and SM. Data will be collected from clinicians and administrators before the implementation of the trial (year 1) and after recruitment for the trial has ended (year 4), and from patients and families throughout the project.

The knowledge gathered from this project is of significant public health relevance as it has potential to facilitate more rapid and timely detection and treatment of first episode psychosis (FEP) by evaluating the utility of systematic screening and communication strategies for psychotic symptoms.

Eligibility criteria: Inclusion Criteria:

* age 12- 30
* ability to participate in assessments in English or Spanish
* ability to provide informed consent (assent for those under age 18)

Exclusion Criteria:

* previous diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or delusional disorder.

Primary outcomes:
measure: Duration of untreated psychosis (DUP)
timeFrame: up to 2 years
Secondary outcomes:
measure: Duration of unrecognized illness (DUI)
timeFrame: Baseline
measure: Number of individuals initiating FEP services
timeFrame: up to 4 years
measure: Number of individuals initiating CHR services
timeFrame: up to 4 years
measure: Patient Satisfaction with Consultation Questionnaire (PSC)
timeFrame: Month 1
measure: Knowledge About Schizophrenia Test (KAST)
timeFrame: Month 1
measure: Stigma Scale (SS)
timeFrame: Month 1
measure: Attitudes about treatment
timeFrame: Month 1
measure: Attitudes about treatment
timeFrame: Month 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Yulia Landa, PsyD, MS
role: PRINCIPAL_INVESTIGATOR
References: