CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 285 enrolled
Drug / intervention
Early Detection (ED) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02069925
NCT02069925N/ACompleted

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

Yale University·interventional·Posted Feb 24, 2014·Updated Apr 21, 2022

In Brief

A clinical study evaluating Early Detection (ED) and Usual Detection for Psychosis and Schizophrenia. Completed, enrolled 285 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2014
Enrollment StartFeb 1, 2014
Primary CompletionFeb 27, 2020
Study CompletionAug 18, 2020
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 12.4 years ago

Interventions

Early Detection (ED)behavioral

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

Usual Detectionbehavioral

This intervention will provide equivalent best practice care without the benefit of an early detection campaign