- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03369730
Reducing the Duration of Untreated Psychosis in the United States
December 10, 2021 updated by: Yulia Landa, Icahn School of Medicine at Mount Sinai
Early Stage Identification and Engagement to Reduce Duration of Untreated Psychosis (EaSIE)
The goal of this project is to investigate whether a systematic screening approach for individuals with first episode psychosis (FEP) can substantially reduce Duration of Untreated Psychosis (DUP).
The study team will evaluate the feasibility of screening a consecutive help-seeking population entering mental health services in order to facilitate early identification of FEP cases, rapid referral to specialty care and engagement in treatment.
Study Overview
Status
Completed
Detailed Description
Psychosis typically emerges in late adolescence or early adulthood, during a vital stage in social and cognitive development, which can have a profoundly adverse impact on an individual's long-term functioning.
Numerous studies find a substantial delay between the onset of psychosis and the initiation of specialty treatment for first episode psychosis (FEP), with the duration of untreated psychosis (DUP) typically over one year in the U.S. Better detection strategies are needed to improve identification of individuals with FEP and to rapidly engage them in Coordinated Specialty Care (CSC) aimed at restoring functioning.
The onset of psychosis is preceded by a prodromal phase characterized by attenuated psychotic symptoms and decline in functioning.
This phase (at-risk mental state: ARMS) is a potential target for strategies aimed at improving outcome by reducing DUP through regular symptom monitoring.
This study will investigate whether a U.S. adaptation of a successful detection approach from the Netherlands can reduce DUP in the U.S. setting.
The Dutch study found that screening of a consecutive help-seeking population entering mental health services captures significantly more FEP and ARMS cases than clinician referrals from mental health centers.
Therefore screening may be an effective strategy for identifying individuals with psychotic symptoms earlier on in the course of their illness.
This study will implement and evaluate a systematic screening for psychotic symptoms in community mental health clinics in order to facilitate rapid identification and engagement in treatment of individuals with FEP.
Individuals ages 12 to 30 entering child/adolescent and adult community mental health clinics (CMHCs) within Mount Sinai Health System will be screened with the Prodromal Questionnaire - Brief Version (PQ-B).
Those who screen positive will be assessed by the Structured Interview for Prodromal Syndromes (SIPS) and referred to stage-specific specialty care.
Individuals with FEP will be referred to CSC programs: OnTrackNY and PEER.
Individuals with ARMS will be monitored and referred to ICanFeelBetter program for ARMS.
DUP will be measured for all individuals who meet SIPS psychosis criteria.
The study team hypothesizes that screening for psychotic symptoms in CMHCs will be feasible and acceptable, and that the average DUP of FEP individuals identified with screening will be less than 3 months, the maximum time between onset of psychotic symptoms and engagement in CSC recommended by the World Health Organization.
In order to optimize screening and treatment engagement strategies for reducing DUP, the clinical team will identify facilitators and barriers to FEP care through in-depth qualitative interviews with patients and caregivers, and by mapping pathways to FEP care.
The study team will also conduct in-depth qualitative interviews with clinicians to explore their experience with the screening and referral process.
Study Type
Observational
Enrollment (Actual)
94
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Trustees of Boston University
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New York
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New York, New York, United States, 10029
- Icahn School of Medicine at Mount Sinai
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New York, New York, United States, 10027
- Research Foundation/City University of New York (CUNY) on behalf of CUNY Graduate School
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 30 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Individuals ages 12 to 30 entering child/adolescent and adult community mental health clinics.
Description
Inclusion Criteria:
- age 12- 30
- ability to participate in assessments in English
- ability to provide informed consent (assent for those under age 18)
- meet criteria for psychosis or psychosis risk on SIPS
Exclusion Criteria:
- previous diagnosis of schizophrenia or schizoaffective disorder.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Untreated Psychosis (DUP)
Time Frame: Day 1
|
The DUP is defined as the time, in weeks, between onset of psychotic symptoms and initiation of FEP treatment, in the case of this study, entry into Coordinated Specialty Care (CSC) programs for first episode psychosis (FEP).
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Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of completed PQ-B screen.
Time Frame: Day 1
|
Rate of completed Prodromal Questionnaire - Brief Version (PQ-B) of incoming patients in clinics.
Screen given as part of standard care.
The PQ-B is a 21-item screening measure used to predict classification of psychosis or psychosis-risk on the Structured Interview for Psychosis-risk Syndromes (SIPS).
|
Day 1
|
Rate of completed SIPS
Time Frame: Day 1
|
Rate of completed Interview for Psychosis-risk Syndromes (SIPS) of incoming patients in clinics.
Screen given as part of standard care.
SIPS is a structured interview for diagnosing a clinical high risk (CHR) syndrome for psychosis and cases of first episode psychosis (FEP).
|
Day 1
|
Rates of FEP cases
Time Frame: Day 1
|
Rates of (First Episode Psychosis) FEP cases detected
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Day 1
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Rate of ARMS cases
Time Frame: Day 1
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Rate of At Risk Mental State (ARMS) cases detected
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Day 1
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Rate of CHR cases
Time Frame: Day 1
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Rate of Clinical High Risk for Psychosis (CHR) cases detected
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Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Addington J, Heinssen RK, Robinson DG, Schooler NR, Marcy P, Brunette MF, Correll CU, Estroff S, Mueser KT, Penn D, Robinson JA, Rosenheck RA, Azrin ST, Goldstein AB, Severe J, Kane JM. Duration of Untreated Psychosis in Community Treatment Settings in the United States. Psychiatr Serv. 2015 Jul;66(7):753-6. doi: 10.1176/appi.ps.201400124. Epub 2015 Jan 15.
- Dixon LB, Goldman HH, Bennett ME, Wang Y, McNamara KA, Mendon SJ, Goldstein AB, Choi CW, Lee RJ, Lieberman JA, Essock SM. Implementing Coordinated Specialty Care for Early Psychosis: The RAISE Connection Program. Psychiatr Serv. 2015 Jul;66(7):691-8. doi: 10.1176/appi.ps.201400281. Epub 2015 Mar 16.
- Rietdijk J, Klaassen R, Ising H, Dragt S, Nieman DH, van de Kamp J, Cuijpers P, Linszen D, van der Gaag M. Detection of people at risk of developing a first psychosis: comparison of two recruitment strategies. Acta Psychiatr Scand. 2012 Jul;126(1):21-30. doi: 10.1111/j.1600-0447.2012.01839.x. Epub 2012 Feb 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 19, 2018
Primary Completion (ACTUAL)
September 15, 2021
Study Completion (ACTUAL)
September 15, 2021
Study Registration Dates
First Submitted
December 6, 2017
First Submitted That Met QC Criteria
December 6, 2017
First Posted (ACTUAL)
December 12, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 14, 2021
Last Update Submitted That Met QC Criteria
December 10, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 17-0655
- R34MH115463 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
In accordance with NIH policy, a de-identified dataset will be uploaded to the NIMH Data Archive: the National Database for Clinical Trials Related to Mental Illness.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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