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Specialized Treatment Early in Psychosis (STEP) (STEP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00309452
First received: March 29, 2006
Last updated: September 12, 2016
Last verified: September 2016
  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.

Condition Intervention
Schizophrenia and Disorders With Psychotic Features
Behavioral: Cognitive Behavioral Group Therapy
Behavioral: Cognitive remediation
Drug: Medications
Behavioral: MFG
Behavioral: Assertive case management
Other: Treatment as Usual in the community

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Number of Patients Hospitalized [ Time Frame: 1 year after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relapse [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
    Data was not collected, instead Hospitalization (primary outcome) was used as a proxy

  • Overall Functioning- Global Assessment of Functioning [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Treatment Satisfaction [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • Adherence- in Contact With Mental Health Services [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of participants in contact with mental health services. Collected via self-report.

  • Substance Use [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
  • Subjects What Committed 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 ]
    Total annual cost per patient


Enrollment: 120
Study Start Date: March 2006
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment as usual
Referral to community providers.
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.
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
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.

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.
  Eligibility

Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00309452

Locations
United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Vinod H Srihari, M.D. Yale University School of Medicine & Connecticut Mental Health Center
Study Chair: Scott Woods, M.D. Yale University
  More Information

Additional Information:
Publications:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00309452     History of Changes
Other Study ID Numbers: 0601001013 
Study First Received: March 29, 2006
Results First Received: May 25, 2016
Last Updated: September 12, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Yale University:
First episode psychosis
Specialized care
Phase-specific treatment
Schizophrenia
Disorders with psychotic features

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

ClinicalTrials.gov processed this record on December 08, 2016