STEP-ED: Reducing Duration of Untreated Psychosis and Its Impact in the U.S.
| Status: | Recruiting |
|---|---|
| Conditions: | Schizophrenia, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 16 - 35 |
| Updated: | 1/6/2019 |
| Start Date: | February 2014 |
| End Date: | February 2019 |
| Contact: | Philip Markovich, B.A. |
| Email: | philip.markovich@yale.edu |
| Phone: | 203-974-7043 |
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.
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.
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.
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.
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
We found this trial at
2
sites
New Haven, Connecticut 6520
(203) 432-4771
Principal Investigator: Vinod H. Srihari, M.D.
Phone: 203-974-7043
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Boston, Massachusetts 02215
Principal Investigator: Larry Seidman, PhD
Phone: 617-754-1238
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