Specialized Treatment Early in Psychosis (STEP)

Conditions

Schizophrenia and Disorders With Psychotic Features

Trial Phase

N/A

Trial Purpose and Description

Trial Purpose

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.


Trial 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.


Participation Guidelines

Age:
16 Years - 45 Years
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  1. Age 16-45
  2. Meets DSM-IV schizophrenia spectrum psychosis or affective psychosis according to the SCID
  3. ≤8 weeks of received antipsychotic treatment lifetime at time of referral
  4. Willing to be treated in New Haven

Exclusion Criteria:

  1. Psychosis believed due to substance use (based on the SCID)
  2. Unable or unwilling to give informed consent
  3. MR as indicated by receipt of services from Dept of Mental Retardation
Sponsor:
Yale University
Dates:
March 2006
Last Updated:
September 17, 2013
Study HIC#:
0601001013

Clinicaltrials.gov ID: NCT00309452