Clinical trial NCT02069925: STEP-ED: Reducing Duration of Untreated Psychosis and Its Impact in the U.S.
Official title: STEP-ED: Reducing Duration of Untreated Psychosis and Its Impact in the U.S.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Schizophrenia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Harvard University
name: National Institute of Mental Health (NIMH)
First posted: 2014-02-24
Enrollment: 285
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of Untreated Psychosis (DUP)
timeFrame: One year before, during campaign and one year after end of campaign
Secondary outcomes:
measure: Levels of social and occupational functioning
timeFrame: 1 year after enrollment in STEP/PREP
measure: Change in levels of social and occupational functioning- social
timeFrame: 6 months and 12 months
measure: Change in levels of social and occupational functioning- roles
timeFrame: 6 months and 12 months
Other outcomes:
measure: Change in improved labor market / workforce participation and healthcare utilization
timeFrame: 6 months and 12 months
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Boston
country: United States
facility: Massachusetts Mental Health Center
state: Massachusetts
Study officials:
affiliation: Yale University
name: Vinod Srihari, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Annamalai A, Palmese LB, Chwastiak LA, Srihari VH, Tek C. High rates of obstructive sleep apnea symptoms among patients with schizophrenia. Psychosomatics. 2015 Jan-Feb;56(1):59-66. doi: 10.1016/j.psym.2014.02.009. Epub 2014 Mar 2.
citation: Tek C, Palmese LB, Krystal AD, Srihari VH, DeGeorge PC, Reutenauer EL, Guloksuz S. The impact of eszopiclone on sleep and cognition in patients with schizophrenia and insomnia: a double-blind, randomized, placebo-controlled trial. Schizophr Res. 2014 Dec;160(1-3):180-5. doi: 10.1016/j.schres.2014.10.002. Epub 2014 Oct 29.
citation: Tek C, Kucukgoncu S, Guloksuz S, Woods SW, Srihari VH, Annamalai A. Antipsychotic-induced weight gain in first-episode psychosis patients: a meta-analysis of differential effects of antipsychotic medications. Early Interv Psychiatry. 2016 Jun;10(3):193-202. doi: 10.1111/eip.12251. Epub 2015 May 12.
citation: Kline ER, DeTore NR, Keefe K, Seidman LJ, Srihari VH, Keshavan MS, Guyer M. Development and validation of the client engagement and service use scale: A pilot study. Schizophr Res. 2018 Nov;201:343-346. doi: 10.1016/j.schres.2018.05.006.
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citation: Srihari VH, Jani A, Gray M. Early Intervention for Psychotic Disorders: Building Population Health Systems. JAMA Psychiatry. 2016 Feb;73(2):101-2. doi: 10.1001/jamapsychiatry.2015.2821. No abstract available.
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