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

Schizophrenia Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders
• Schizophrenia

• NCT number: NCT02069925
• Study type: Interventional
• Source: Yale University
• Status: Completed
• Phase: N/A
• Start date: February 1, 2014
• Completion date: August 18, 2020