Enhanced Screening & Communication for Psychosis

(EaSIE Trial)

Overseen By Yulia Landa

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Schizophrenia, Schizoaffective, Schizophreniform, Delusional

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: up to 2 years

912 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Screening and Communication Method (SCM) and Screening Method (SM) for psychosis?

Research shows that early intervention and targeted outreach can improve the identification and outcomes of individuals at high risk for psychosis. Early intervention programs have been effective in reducing the duration of untreated psychosis, leading to better outcomes. ^{1 2 3 4 5}

Is the Enhanced Screening & Communication for Psychosis treatment safe for humans?

The research articles reviewed do not provide specific safety data for the Enhanced Screening & Communication for Psychosis treatment or its related methods. Therefore, no relevant safety information is available from these sources. ^{2 6 7 8 9}

How does the Screening and Communication Method (SCM) differ from other treatments for psychosis?

The Screening and Communication Method (SCM) is unique because it focuses on early detection and communication strategies to identify individuals at high risk for psychosis, using low-cost, brief self-report questionnaires. This approach aims to prevent the onset of severe psychosis by improving early identification and intervention, which is different from traditional treatments that may not emphasize early screening and communication. ^{1 7 10 11 12}

What is the purpose of this trial?

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.

Research Team

Yulia Landa

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Inclusion Criteria

I can complete assessments in English or Spanish.

I am between 12 and 30 years old.

Ability to provide informed consent (assent for those under age 18)

Exclusion Criteria

Previous diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or delusional disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Baseline

1 visit (in-person)

Treatment

Participants receive systematic screening and communication methods to reduce the duration of untreated psychosis

up to 2 years

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 4 years

Treatment Details

Interventions

• Screening and Communication Method (SCM)
• Screening Method (SM)

Trial Overview 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.

Participant Groups

Group I: Screening and Communication Method (SCM) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

The targeted case identification intervention significantly increased referrals to the clinical high-risk unit for first-episode psychosis, with a notable rise in eligible cases (P = 0.01 and P = 0.03, respectively).

The majority of referrals came from the first-episode psychosis service, indicating that integrated outreach strategies can effectively enhance the identification of individuals at high risk for psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an integrated outreach intervention targeting multiple stages of early psychosis improve the identification of individuals at clinical high risk? McIlwaine, SV., Jordan, G., Pruessner, M., et al.[2019]

The Mobile Assessment and Treatment for Schizophrenia (MATS) program, which used text messaging over 12 weeks, significantly improved medication adherence and social interactions, particularly for individuals living independently.

Participants also experienced a notable reduction in the severity of auditory hallucinations, indicating that low-intensity interventions like MATS can effectively enhance outcomes for higher functioning individuals with schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Assessment and Treatment for Schizophrenia (MATS): a pilot trial of an interactive text-messaging intervention for medication adherence, socialization, and auditory hallucinations. Granholm, E., Ben-Zeev, D., Link, PC., et al.[2022]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Does an integrated outreach intervention targeting multiple stages of early psychosis improve the identification of individuals at clinical high risk? [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Mobile Assessment and Treatment for Schizophrenia (MATS): a pilot trial of an interactive text-messaging intervention for medication adherence, socialization, and auditory hallucinations. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The prevention of schizophrenia. [2019]

4. Australia pubmed.ncbi.nlm.nih.gov

First-episode psychosis patients recruited into treatment via early detection teams versus ordinary pathways: course and health service use during 5 years. [2011]

5. United States pubmed.ncbi.nlm.nih.gov

An instrument for measurement of outcomes of care for schizophrenia. Issues in development and implementation. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Integrating non-drug treatments in early schizophrenia. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Psychosis risk screening: a systematic review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Early, targeted pharmacotherapeutic intervention in schizophrenia. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Estimating suicidality as an outcome measure in clinical trials of suicide in schizophrenia. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Clinical and functional outcomes after 2 years in the early detection and intervention for the prevention of psychosis multisite effectiveness trial. [2022]

11. Australia pubmed.ncbi.nlm.nih.gov

Optimizing health-care systems to promote early detection of psychosis. [2011]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Psychosis risk screening in youth: a validation study of three self-report measures of attenuated psychosis symptoms. [2022]