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

NCT05509998 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 912

Last updated 2025-07-20

No results posted yet for this study

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)

Interventions

BEHAVIORAL

Screening Method (SM)

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.

BEHAVIORAL

Screening and Communication Method (SCM)

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.

Sponsors & Collaborators

Principal Investigators

  • Yulia Landa, PsyD, MS · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05509998 on ClinicalTrials.gov