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Reducing the Duration of Untreated Psychosis in the United States

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ClinicalTrials.gov Identifier: NCT03369730
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date December 6, 2017
First Posted Date December 12, 2017
Last Update Posted Date April 19, 2019
Actual Study Start Date February 19, 2018
Estimated Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 6, 2017)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 6, 2017)
  • 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).
  • 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).
  • Rates of FEP cases [ Time Frame: Day 1 ]
    Rates of (First Episode Psychosis) FEP cases detected
  • Rate of ARMS cases [ Time Frame: Day 1 ]
    Rate of At Risk Mental State (ARMS) cases detected
  • Rate of CHR cases [ Time Frame: Day 1 ]
    Rate of Clinical High Risk for Psychosis (CHR) cases detected
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Reducing the Duration of Untreated Psychosis in the United States
Official Title Early Stage Identification and Engagement to Reduce Duration of Untreated Psychosis (EaSIE)
Brief Summary 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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Individuals ages 12 to 30 entering child/adolescent and adult community mental health clinics.
Condition
  • First Episode Psychosis (FEP)
  • At Risk Mental State (ARMS)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 6, 2017)
94
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 15, 2020
Estimated Primary Completion Date September 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 30 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Yulia Landa, PsyD, MS 212-659-8732 yulia.landa@mssm.edu
Contact: Rachel M Jespersen, LMSW 212-659-5606 rachel.jespersen@mssm.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03369730
Other Study ID Numbers GCO 17-0655
R34MH115463 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
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.
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor Icahn School of Medicine at Mount Sinai
Collaborators National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Yulia Landa, PsyD, MS Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2019