STEP-ED: Reducing Duration of Untreated Psychosis and Its Impact in the U.S.
Condition: Psychosis; Schizophrenia
MeSH terms: Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional

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.
    

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.
    

Intervention name(s): Early Detection (ED); Usual Detection
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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; This intervention will provide equivalent best practice care without the benefit of an early detection campaign
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment