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

Completed · Not applicable

Conditions studied: Psychosis, Schizophrenia

In brief

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.

Key facts

Study ID

NCT02069925

Run by

Yale University

People needed

285

Starts

2014-02-01

Expected to finish

2020-08-18

Last updated by the study team

2022-04-21

Who can join

Age: 16 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Yale University — New Haven, Connecticut, United States
• Massachusetts Mental Health Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.