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Specialized Treatment Early in Psychosis (STEP) (STEP)

This study has been completed.
Information provided by (Responsible Party):
Yale University Identifier:
First received: March 29, 2006
Last updated: December 12, 2016
Last verified: December 2016

March 29, 2006
December 12, 2016
March 2006
August 2013   (Final data collection date for primary outcome measure)
Number of Patients Hospitalized [ Time Frame: 1 year after enrollment ]
Rehospitalization measured every 6 months for 5 years.
Complete list of historical versions of study NCT00309452 on Archive Site
  • Relapse [ Time Frame: every 6 months ]
    Data was not collected, instead Hospitalization (primary outcome) was used as a proxy
  • Overall Functioning- Global Assessment of Functioning [ Time Frame: 12 months ]

    The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. A higher score indicates better functioning.

    The score reported is a change from baseline. The change was calculated as score at 12 months minus score from baseline. A positive score indicates higher functioning.

  • Quality of Life- Heinrich's Quality of Life Scale [ Time Frame: 12 months ]

    The Quality of Life Scale (QLS) is a 21-item scale rated from a semistructured interview providing information on symptoms and functioning during the preceding 4 weeks. Each item is rated on a seven point scale, and a higher score reflects normal or unimpaired functioning. The range is from 0 to 126.

    The score reflected is a change from baseline. Total score at 12 months minus total score at baseline. A positive score indicates better mental health.

  • Vocationally Engaged [ Time Frame: 1 year after enrollment ]
  • Treatment Satisfaction [ Time Frame: every 6 months ]
  • Adherence- in Contact With Mental Health Services [ Time Frame: 1 year ]
    Number of participants in contact with mental health services. Collected via self-report.
  • Substance Use [ Time Frame: every 6 months ]
  • Subjects Who Committed Self-harm and Violence [ Time Frame: 12 months ]
    The number of subjects who committed an act of self-harm or violence. This data was collected at 12 months.
  • Medication (Including Metabolic) Side Effects [ Time Frame: every 6 months ]
  • Economic Measures Including Service Use, Cost of Care and Forensic Data. [ Time Frame: every 6 months ]
    Total annual cost per patient
  • 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.
Not Provided
Not Provided
Specialized Treatment Early in Psychosis (STEP)
Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.
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.
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.
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia and Disorders With Psychotic Features
  • Behavioral: Cognitive Behavioral Group Therapy
    once per week
  • Behavioral: Cognitive remediation
    as needed
  • Drug: Medications
    Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
  • Behavioral: MFG
    Multi-Family psychoeducation Group based on the model published by McFarlane et al.
  • Behavioral: Assertive case management
    Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports.
  • Other: Treatment as Usual in the community
    Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic.
  • Active Comparator: Treatment as usual
    Referral to community providers.
    Intervention: Other: Treatment as Usual in the community
  • Experimental: STEP Care
    Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.
    • Behavioral: Cognitive Behavioral Group Therapy
    • Behavioral: Cognitive remediation
    • Drug: Medications
    • Behavioral: MFG
    • Behavioral: Assertive case management

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2013
August 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 45 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Yale University
Yale University
Not Provided
Principal Investigator: Vinod H Srihari, M.D. Yale University School of Medicine & Connecticut Mental Health Center
Study Chair: Scott Woods, M.D. Yale University
Yale University
December 2016

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