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

Study Overview
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Brief Summary
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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: 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; 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
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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.

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

Conditions
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Psychosis, Schizophrenia

Intervention / Treatment
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* Behavioral: Early Detection (ED)
* Behavioral: Usual Detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Detection (ED)<br>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: Early Detection (ED)<br>* 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<br>Behavioral: Usual Detection<br>* This intervention will provide equivalent best practice care without the benefit of an early detection campaign<br>|
| Active Comparator: Usual Detection<br>This intervention will provide equivalent best practice care without the benefit of an early detection campaign | Behavioral: Usual Detection<br>* This intervention will provide equivalent best practice care without the benefit of an early detection campaign<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Untreated Psychosis (DUP) | Time from onset of psychosis to first antipsychotic (DUP-Demand); Time from first antipsychotic to enrollment in STEP/PREP (DUP-Supply); Time from onset of psychosis to enrollment in STEP/PREP (DUP-Total) | One year before, during campaign and one year after end of campaign | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of social and occupational functioning | A trained assessor will administer the positive and negative syndrome scale (PANSS) scale to every subject for levels of social and occupational functioning. The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210. | 1 year after enrollment in STEP/PREP | 
| Change in levels of social and occupational functioning- social | The Global Functioning: Social scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning). | 6 months and 12 months | 
| Change in levels of social and occupational functioning- roles | The Global Functioning: Role scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning). | 6 months and 12 months |