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

Study acronym: EaSIE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status changed: Enrolling by Invitation → Recruiting
    • Secondary endpoints: details revised at 4 of 8 entries
    • Site details revised
    • Eligibility criteria expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv7
  3. Primary and study completion dates: Apr 2027 to Apr 30, 2027v6
  4. Trial status: Recruiting to Enrolling by Invitation
    • Primary and study completion dates: Apr 30, 2027 to Apr 2027
    • Site details revised
    v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Mar 1, 2023 to May 1, 2023
    • Primary and study completion dates: Feb 28, 2027 to Apr 30, 2027
    v3
  2. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05509998
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: National Institute of Mental Health (NIMH)
Conditions
(from sponsor)		 First Episode Psychosis (FEP), Clinical High Risk for Psychosis (CHR)
Related terms Communication
Enrollment 912 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov