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

NCT05509998 | Enrolling By Invitation DMC

• 2 other identifiers: GCO 21-16311R01MH130354-01
• Study Type: interventional
• Target: 912
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Duration of untreated psychosis (DUP)

  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.

  up to 2 years

Secondary Outcomes (8)

• Duration of unrecognized illness (DUI)

  Baseline

• Number of individuals initiating FEP services

  up to 4 years

• Number of individuals initiating CHR services

  up to 4 years

• Patient Satisfaction with Consultation Questionnaire (PSC)

  Month 1

• Knowledge About Schizophrenia Test (KAST)

  Month 1

Study Arms (2)

Screening Method (SM)

ACTIVE COMPARATOR

In the SM condition all consecutive incoming patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Evaluating clinicians will meet with patients to discuss findings and make referrals to specialty care as appropriate. The evaluating clinician will follow-up with patients referred to CSC and CHR programs to determine date of initial engagement. This information will be corroborated with records from CHR and FEP programs.

Behavioral: Screening Method (SM)

Screening and Communication Method (SCM)

EXPERIMENTAL

In the SCM condition, the same screening and evaluation procedures described above will continue, but clinicians conducting evaluations and making referrals will be trained to discuss findings and provide referrals using the ComPsych model. Following the evaluation, the clinician who conducted the evaluation will schedule a session with the patient, their family, and their treatment team (as applicable) and use the ComPsych model to discuss the findings of the evaluation, provide psychoeducation, and make referrals to specialty FEP or CHR services, as appropriate. The evaluating clinician will follow-up with patients referred to CSC and CHR programs to determine date of initial engagement. This information will be corroborated with records from CHR and FEP programs.

Behavioral: Screening and Communication Method (SCM)

Interventions

Screening Method (SM) BEHAVIORAL

All consecutive incoming patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Evaluating clinicians will meet with patients to discuss findings and make referrals to specialty care as appropriate.

Screening Method (SM)

Screening and Communication Method (SCM) BEHAVIORAL

Clinicians will be trained to discuss findings and provide referrals using the ComPsych model. ComPsych prepares clinicians to effectively communicate diagnostic, prognostic and treatment information about FEP and CHR with patients and families, using a model that instils realistic hope and provides information effectively to encourage shared decision making about treatment. All consecutive patients ages 12-30 entering mental health services will complete a self-report screener, the PQ-B on intake. The intake clinician will review the PQ-B and refer all patients who endorse 6 or more items for evaluation with the SIPS to determine whether the patient meets criteria for psychosis, CHR, or neither. Following the evaluation, the clinician will schedule a session with the patient, their family, and their treatment team (as applicable) and use the ComPsych model to discuss the findings of the evaluation, provide psychoeducation, and make referrals to specialty services, as appropriate.

Screening and Communication Method (SCM)

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Communication

Interventions

High-Throughput Screening Assays; Mass Screening

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Technology, Pharmaceutical; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Yulia Landa, PsyD, MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Stepped Wedge Cluster Randomized Controlled Trial

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 22, 2022
• Study Start: May 1, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)