Reducing the Duration of Untreated Psychosis in the United States: The Impact of Screening and Systematic Communication

Not Applicable

• Conditions: Clinical High Risk for Psychosis (CHR); First Episode Psychosis (FEP)

• Registration Number: NCT05509998
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Study Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-19
• Study First Posted: 2022-08-22
• Study Start: 2023-05-01
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-20
• Primary Completion: 2027-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 912

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Duration of untreated psychosis (DUP)	up to 2 years	The DUP is defined as the time, in weeks, between onset of psychotic symptoms (measured by the Symptom Onset in Schizophrenia Scale) and initiation of FEP treatment (date of intake into Coordinated Specialty Care (CSC) programs for first episode psychosis.

Secondary Outcome Measures

Name	Time	Method
Number of individuals initiating CHR services	up to 4 years	Number of individuals initiating CHR services
Knowledge About Schizophrenia Test (KAST)	Month 1	A self-report scale adapted from the Knowledge About Schizophrenia Test (KAST) to assess understanding of psychosis. KAST is an 18 item instrument, full scale range from 1-18, higher score indicates more knowledge.
Attitudes about treatment	Month 1	Patients will be asked how much they agree (on a 5-point likert scale) with the statement: "I think \[program\] is likely to help me with my problems". Score from 1-5, with higher score indicating more agreement.
Duration of unrecognized illness (DUI)	Baseline	The DUI is defined as the time, in weeks, between onset of psychotic symptoms (measured by the Symptom Onset in Schizophrenia Scale) and evaluation with the SIPS.
Patient Satisfaction with Consultation Questionnaire (PSC)	Month 1	This 22-item measure uses a 5-point Likert scale to measure satisfaction with amount/quality of information presented, emotional support and level of patient and family participation. The PSC has high internal reliability (Cronbach's Alpha .91). Used extensively in cancer studies, it is sensitive to differences in consultant behavior. For the purposes of this study, 4 items were removed. PSC will be administered to patients and family members in both SCM and SM conditions after a consultation where SIPS feedback is provided and referral made (in SCM ComPsych model will be used).; Full scale from 18 - 90, with higher score indicating greater satisfaction
Stigma Scale (SS)	Month 1	28-item Stigma Scale (SS) Full scale from 28 - 140, higher score indicates higher impact of stigma
Number of individuals initiating FEP services	up to 4 years	Number of individuals initiating FEP services

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States