STEP-ED: Reducing Duration of Untreated Psychosis and Its Impact in the U.S.

April 19, 2022 updated by: Yale University

The guiding questions for this study are: can a U.S. adaptation of a successful Scandinavian approach (TIPS) to early detection substantially reduce the duration of untreated psychosis (DUP) and improve outcomes beyond an established first-episode service (FES)?

The primary aim of this study is:

  1. To determine whether an early detection intervention can reduce DUP in the US, as compared to usual detection. Early detection (ED) will be implemented in one US community (New Haven, CT), and usual detection efforts will continue in another (Boston, MA). DUP will be measured at admission to the corresponding first-episode services (STEP & PREP) in each community, over one year before and throughout ED implementation. The investigators hypothesize that DUP will be reduced significantly in the early detection site compared to the usual detection site;
  2. A secondary aim is to determine whether DUP reduction can augment the outcomes of established FES on outcomes in the U.S. The investigators will measure symptoms, functioning and engagement with treatment at entry and over 1 year at each site. The investigators hypothesize that shorter DUP at one FES (STEP) will predict reduced distress and illness severity at entry and better early outcomes at STEP compared to PREP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Early detection, or reducing the duration of untreated psychosis (DUP) can substantially ameliorate the distress and disability caused by psychotic illnesses. The TIPS project in Scandinavia used a combination of public and targeted education campaigns coupled with rapid availability of comprehensive services to improve the identification, referral and early treatment of psychotic illness. By targeting the dual 'bottlenecks' of inadequate mental health literacy and delayed access to effective treatment, TIPS significantly reduced DUP2 and experimentally demonstrated improved clinical presentations and outcomes.

Effective service models for new onset psychosis exist in the U.S. Multi-element specialty 'first-episode' services (FES), highlighted in this FOA, provide care that is adapted to the specific needs of younger patients and their families and can improve symptoms and functional outcomes during the critical early phase of psychotic illnesses. The NIH-funded Specialized Treatment in Early Psychosis (STEP, New Haven) project, included the first U.S.-based randomized controlled trial to establish the feasibility and effectiveness of a public-sector approach to FES.5 The Prevention and Recovery in Early Psychosis (PREP, Boston) clinic has advanced a similar model of care within an analogous public-academic collaboration.

What is required, as the next logical step, is a test of the effectiveness of TIPS' powerful approach to early detection in a policy-relevant U.S. setting, where relatively fragmented pathways to care raise both the challenges and potential public health impact of early detection. The expertise within the investigators investigative team in the design of early detection and the presence of 2 similar, effective, geographically separated and collaborative FES programs (STEP and PREP) presents an excellent opportunity to conduct such a test and thereby advance secondary prevention for psychotic illnesses in the U.S.

Study Type

Interventional

Enrollment (Actual)

285

Phase

  • Not Applicable

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

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8234
        • Yale University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Massachusetts Mental Health Center

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

16 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 16 to 35 years old,
  • Within first 3 years of psychosis onset (per pre-defined SOS threshold criteria)
  • Willing travel to local First Episode Service (STEP, New Haven or PREP, Boston) for treatment;
  • Must live in target catchment towns for New Haven site (New Haven, East Haven, West Haven, North Haven, Hamden, Bethany, Orange, Woodbridge, Milford, and Branford) and Boston site (anywhere in Commonwealth of MA)

Exclusion Criteria:

  • Established diagnosis of affective psychotic illness (Bipolar disorder or MDD with psychotic features) or psychosis secondary to substance use or a medical illness
  • Unable to communicate in English
  • IQ<70 or eligible for DDS (Department of Developmental Services) care
  • legally mandated to enter treatment or otherwise unable to give free, informed consent
  • Unable to reliably determine DUP
  • Unstable medical illness

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Detection (ED)
This intervention consists of educational campaigns directed at patients & families (who have yet to seek care) and professionals in educational and clinical settings to hasten referral of individuals with new onset psychosis to an established, best-practice first-episode service (i.e. STEP). Interleaved with this educational campaign will be procedures to make the STEP clinic more rapidly responsive to referrals to further shorten the duration of untreated psychosis
Behavioral: Early Detection (ED)
This intervention consists of educational campaigns directed at patients & families (who have yet to seek care) and professionals in educational and clinical settings to hasten referral of individuals with new onset psychosis to an established, best-practice first-episode service (i.e. STEP). Interleaved with this educational campaign will be procedures to make the STEP clinic more rapidly responsive to referrals to further shorten the duration of untreated psychosis
Behavioral: Usual Detection
This intervention will provide equivalent best practice care without the benefit of an early detection campaign
Active Comparator: Usual Detection
This intervention will provide equivalent best practice care without the benefit of an early detection campaign
Behavioral: Usual Detection
This intervention will provide equivalent best practice care without the benefit of an early detection campaign

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Untreated Psychosis (DUP)
Time Frame: One year before, during campaign and one year after end of campaign
Time from onset of psychosis to first antipsychotic (DUP-Demand); Time from first antipsychotic to enrollment in STEP/PREP (DUP-Supply); Time from onset of psychosis to enrollment in STEP/PREP (DUP-Total)
One year before, during campaign and one year after end of campaign

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of social and occupational functioning
Time Frame: 1 year after enrollment in STEP/PREP
A trained assessor will administer the positive and negative syndrome scale (PANSS) scale to every subject for levels of social and occupational functioning. The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210.
1 year after enrollment in STEP/PREP
Change in levels of social and occupational functioning- social
Time Frame: 6 months and 12 months
The Global Functioning: Social scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).
6 months and 12 months
Change in levels of social and occupational functioning- roles
Time Frame: 6 months and 12 months
The Global Functioning: Role scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).
6 months and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in improved labor market / workforce participation and healthcare utilization
Time Frame: 6 months and 12 months
A trained assessor will administer the Services Utilization and Resources Form for Schizophrenia (SURF) instrument to assess workforce participation and other measures relevant to healthcare utilization. The SURF is a multi-item form that uses participants' or caregivers' report to document comprehensively the number, type, and duration of health services and consumption of non-health resources, such as criminal justice events and public assistance
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute of Mental Health (NIMH)
Harvard University

Investigators

  • Principal Investigator: Vinod Srihari, MD, Yale University

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

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 1, 2014

Primary Completion (Actual)

February 27, 2020

Study Completion (Actual)

August 18, 2020

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

February 21, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1310012846
  • 1R01MH103831-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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