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

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ClinicalTrials.gov Identifier: NCT02069925
Recruitment Status : Recruiting
First Posted : February 24, 2014
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Harvard University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Psychosis Schizophrenia Behavioral: Early Detection (ED) Behavioral: Usual Detection Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STEP-ED: Reducing Duration of Untreated Psychosis and Its Impact in the U.S.
Study Start Date : February 2014
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Behavioral: 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

Behavioral: Usual Detection
This intervention will provide equivalent best practice care without the benefit of an early detection campaign

Active Comparator: Usual Detection
This intervention will provide equivalent best practice care without the benefit of an early detection campaign
Behavioral: Usual Detection
This intervention will provide equivalent best practice care without the benefit of an early detection campaign




Primary Outcome Measures :
  1. Proportion of Participants with Duration of Untreated Psychosis (DUP) [ Time Frame: 3 months ]
    The primary outcome of interest, proportion of participants at each site with DUP < 3 months, will be calculated for the "pre period" (first year of the study, prior to initiation of ED intervention at STEP)

  2. Proportion of Participants with Duration of Untreated Psychosis DUP [ Time Frame: 3 years ]


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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069925


Contacts
Contact: Philip Markovich, B.A. 203-974-7043 philip.markovich@yale.edu
Contact: Barbara Walsh, PhD (203) 974-7052 barbara.walsh@yale.edu

Locations
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06520-8234
Contact: Philip Markovich, BA    203-974-7043    philip.markovich@yale.edu   
Contact: Barbara Walsh, PhD    (203) 974-7052    barbara.walsh@yale.edu   
Principal Investigator: Vinod H. Srihari, M.D.         
Sub-Investigator: Scott Woods, M.D.         
Sub-Investigator: Thomas McGlashan, M.D.         
Sub-Investigator: Cenk Tek, M.D.         
United States, Massachusetts
Massachusetts Mental Health Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Larry Seidman, PhD    617-754-1238    lseidman@bidmc.harvard.edu   
Principal Investigator: Larry Seidman, PhD         
Principal Investigator: Matcheri Keshavan, MD         
Sponsors and Collaborators
Yale University
Harvard University
Investigators
Principal Investigator: Vinod Srihari, MD Yale University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02069925     History of Changes
Other Study ID Numbers: 1310012846
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders