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Enhanced Screening & Communication for Psychosis (EaSIE Trial)

N/A
Recruiting
Led By Yulia Landa, PsyD, MS
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 12-30
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

EaSIE Trial Summary

This trial is investigating whether an innovative model of communicating information about psychosis and treatment options to patients and families can reduce the duration of untreated psychosis.

Who is the study for?
This trial is for individuals aged 12-30 who may be experiencing their first episode of psychosis or are at high risk for psychosis. They must be able to understand assessments in English or Spanish and give informed consent, with minors providing assent. Those previously diagnosed with schizophrenia-related disorders cannot participate.Check my eligibility
What is being tested?
The study compares two methods: a Screening and Communication Method (SCM) versus just a Screening Method (SM). It aims to see if SCM can shorten the time before people get help for first-time psychosis by improving how we screen for it and communicate treatment options.See study design
What are the potential side effects?
Since this trial focuses on screening methods rather than medication, there aren't direct side effects like you'd expect from drugs. However, participants might experience stress or discomfort during the assessment process.

EaSIE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 30 years old.

EaSIE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of untreated psychosis (DUP)
Secondary outcome measures
Attitudes about treatment
Duration of unrecognized illness (DUI)
Knowledge About Schizophrenia Test (KAST)
+4 more

EaSIE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Screening and Communication Method (SCM)Experimental Treatment1 Intervention
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.
Group II: Screening Method (SM)Active Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
854 Previous Clinical Trials
535,081 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,776 Previous Clinical Trials
2,672,848 Total Patients Enrolled
Yulia Landa, PsyD, MSPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
1 Previous Clinical Trials
94 Total Patients Enrolled

Media Library

Screening and Communication Method (SCM) Clinical Trial Eligibility Overview. Trial Name: NCT05509998 — N/A
First Episode Psychosis Research Study Groups: Screening Method (SM), Screening and Communication Method (SCM)
First Episode Psychosis Clinical Trial 2023: Screening and Communication Method (SCM) Highlights & Side Effects. Trial Name: NCT05509998 — N/A
Screening and Communication Method (SCM) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05509998 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to join the research project?

"This clinical trial is seeking 912 participants aged between 12 and 30 who have been diagnosed with a psychotic disorder. In addition, all candidates must be able to provide informed consent (or assent for underage patients) as well as complete assessments in either English or Spanish."

Answered by AI

Does this clinical trial have an age limit, and if so, what is it?

"This trial seeks to include participants aged between 12 and 30 years old."

Answered by AI

Is there still room to enroll patients in this research study?

"Clinicaltrials.gov divulges that this medical trial is no longer accepting participants, as it was first posted on March 1st 2023 and edited for the last time October 11th 2022. However, there are 420 other studies in progress where individuals may be able to enroll themselves in at present."

Answered by AI
~608 spots leftby Apr 2027