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

Not Applicable

Completed

• Conditions: Psychosis; Schizophrenia
• Interventions: Behavioral: Early Detection (ED); Behavioral: Usual Detection

• Registration Number: NCT02069925
• Lead Sponsor: Yale University

Brief 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.

Study Timeline

• Study Start: 2014-02-01
• Study First Submitted: 2014-02-20
• Study First Submitted QC: 2014-02-21
• Study First Posted: 2014-02-24
• Primary Completion: 2020-02-27
• Study Completion: 2020-08-18
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Detection (ED)	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
Early Detection (ED)	Usual Detection	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 Detection	Usual Detection	This intervention will provide equivalent best practice care without the benefit of an early detection campaign

Primary Outcome Measures

Name	Time	Method
Duration of Untreated Psychosis (DUP)	One year before, during campaign and one year after end of campaign	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)

Secondary Outcome Measures

Name	Time	Method
Levels of social and occupational functioning	1 year after enrollment in STEP/PREP	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.
Change in levels of social and occupational functioning- roles	6 months and 12 months	The Global Functioning: Role scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).
Change in levels of social and occupational functioning- social	6 months and 12 months	The Global Functioning: Social scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).

Trial Locations

Locations (2)

Yale University; 🇺🇸 New Haven, Connecticut, United States

Massachusetts Mental Health Center; 🇺🇸 Boston, Massachusetts, United States