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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new approach to screening and discussing psychosis can expedite treatment. It compares two methods: regular screening (Screening Method, SM) and a method that includes detailed communication with patients and families (Screening and Communication Method, SCM). The goal is to assess whether the enhanced communication approach reduces the time to treatment after a first episode of psychosis. Suitable participants are those aged 12 to 30 who have not been previously diagnosed with certain psychotic disorders. As an unphased trial, this study provides a unique opportunity to contribute to innovative mental health care approaches.

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 prior data suggests that this screening and communication method is safe?

Research shows that specific safety information for the Screening and Communication Method (SCM) used for psychosis is not available. This method involves screening and discussing psychosis using a model called ComPsych, but studies have not reported any direct safety issues.

In contrast, researchers have studied the Screening Method (SM) for psychosis for its ability to identify early signs of the condition. Although specific safety details are not mentioned, this method primarily focuses on early detection and referral. It involves low-risk activities like filling out questionnaires and evaluations by healthcare professionals.

Both methods focus on screening and communication, which are generally safe and non-invasive. Research has not reported any negative effects from using these methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Screening & Communication for Psychosis trial because it aims to improve early detection and intervention for young people at risk of psychosis. The Screening and Communication Method (SCM) is particularly promising because it incorporates the ComPsych model, which actively involves patients, their families, and their treatment teams in understanding and managing their condition. This approach not only screens for psychosis but also emphasizes communication and psychoeducation, potentially leading to more effective referrals and earlier engagement with specialized care. Unlike traditional methods that may only focus on clinical evaluation, SCM fosters a more collaborative and informed approach to managing early psychosis symptoms.

What evidence suggests that this screening and communication method is effective for reducing the duration of untreated psychosis?

Research shows that identifying and treating psychosis early can greatly reduce the duration it remains untreated. Studies have found that checking for signs of psychosis during regular doctor visits helps detect it sooner, enabling earlier treatment. In this trial, participants will follow one of two methods. The Screening and Communication Method (SCM) involves patients and their families in discussions, which helps them engage with treatment. Early results suggest SCM might reduce the time it takes for people to receive care. The Screening Method (SM) alone has already successfully identified many cases of psychosis. Both methods in this trial aim to quickly connect people with specialized services, potentially leading to better health outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Yulia Landa

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11140870/

The diagnostic accuracy of screening for psychosis ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9857799/

Effect of Technology-Enhanced Screening in Addition to ...

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thelancet.com

thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00116-0/fulltext

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pmc.ncbi.nlm.nih.gov/articles/PMC10962362/

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8753999/

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This study investigates the use of two brief screening tools to identify psychosis-spectrum symptoms in psychiatrically hospitalized adolescents.

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bmchealthservres.biomedcentral.com

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Effects of Actissist, a digital health intervention for early ...

The primary outcome was change in psychotic symptoms measured by PANSS total score at 12-weeks post-randomization. PANSS, the gold-standard measure of ...