Specialized Treatment Early in Psychosis (STEP) - Tabular View

Tracking Information

First Received Date ^ICMJE

March 29, 2006

Last Updated Date

February 12, 2009

Start Date ^ICMJE

March 2006

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Rehospitalization measured every 6 months for 5 years. [ Time Frame: Assessed every 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Rehospitalization measured every 6 months for 5 years.

Change History

Complete list of historical versions of study NCT00309452 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Relapse [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
Overall functioning [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
Education and employment status [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
Treatment satisfaction [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
Adherence [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
Substance use [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
Adverse events (including self-harm and violence) [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
Medication (including metabolic) side effects [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
Economic measures including service use, cost of care and forensic data. [ Time Frame: every 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Relapse
Overall functioning
Quality of life
Education and employment status
Treatment satisfaction
Adherence
Substance use
Adverse events (including self-harm and violence)
Medication (including metabolic) side effects
Economic measures including service use, cost of care and forensic data.

Descriptive Information

Brief Title ^ICMJE

Specialized Treatment Early in Psychosis (STEP)

Official Title ^ICMJE

Randomized Trial of Usual Care Versus Specialized, Phase-Specific Care in the Public Sector for First Episode Psychosis.

Brief Summary

The purpose of this study is to understand the effectiveness of a specialized package of phase-specific treatments for individuals in the midst of their first episode of psychosis. The pharmacologic and psychosocial treatments will be delivered within a state public mental health center.

Detailed Description

We propose to conduct a clinical trial for first episode psychosis patients not eligible for CMHC services that will compare randomized access to care at CMHC versus the usual procedure of referral to community providers outside CMHC. Patients randomized to access to CMHC services will receive multifaceted, intensive, phase-specific care delivered by a specialized clinical team. This care will include five principal components: antipsychotic prescription, multi-family group therapy, group cognitive behavioral therapy, cognitive remediation and individual case management including supportive, problem solving approaches and a focus on resumption of movement towards educational and/or employment related goals. All consenting subjects will undergo research evaluations every six months for up to five years. Outcomes will be assessed in the domains of re-admission (primary outcome), relapse, symptoms, overall functioning, quality of life, education and employment, treatment satisfaction, adherence, substance use, adverse events (including self-harm) and economic measures including service use, cost of care and forensic data.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Schizophrenia and Disorders With Psychotic Features

Intervention ^ICMJE

Behavioral: Cognitive Behavioral Group Therapy
Behavioral: Cognitive remediation
Drug: Medications
Behavioral: MFG
Behavioral: Assertive case management
Other: Treatment as Usual in the community

Study Arms / Comparison Groups

Active Comparator: Referral to community providers.
Experimental: Integrated and comprehensive treatment provided by a specialized team in a public mental health center.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

March 2011

Estimated Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 16-45
Meets DSM-IV schizophrenia spectrum psychosis or affective psychosis according to the SCID
≤8 weeks of received antipsychotic treatment lifetime at time of referral
Willing to be treated in New Haven

Exclusion Criteria:

Psychosis believed due to substance use (based on the SCID)
Unable or unwilling to give informed consent
MR as indicated by receipt of services from Dept of Mental Retardation

Gender

Both

Ages

16 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Nicholas Breitborde, Ph.D.	(203) 974-7495	nicholas.breitborde@yale.edu
Contact: Vinod Srihari, M.D.	(203) 974-7816	vinod.srihari@yale.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00309452

Responsible Party

Vinod Srihari, MD, Yale University

Study ID Numbers ^ICMJE

0601001013

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Vinod H Srihari, M.D.	Yale University School of Medicine & Connecticut Mental Health Center
Study Chair:	Scott Woods, M.D.	Yale University

Information Provided By

Yale University

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP