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

NCT02069925 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2022-04-21

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Harvard University

    collaborator OTHER
  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Yale University

    lead OTHER

Principal Investigators

  • Vinod Srihari, MD · Yale University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-01
Primary Completion
2020-02-27
Completion
2020-08-18

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02069925 on ClinicalTrials.gov