Specialized Treatment Early in Psychosis (STEP) - Full Text View

Sponsor:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00309452

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:

MedlinePlus related topics: Child Mental Health Mental Disorders Mental Health Psychotic Disorders Schizophrenia

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	March 2006
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (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.	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.

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.

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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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

Contacts

Contact: Vinod Srihari, MD	(203) 974-7816	vinod.srihari@yale.edu
Contact: Scott Woods, M.D.	(203) 974-7300	scott.woods@yale.edu

Locations

United States, Connecticut
Connecticut Mental Health Center	Recruiting
New Haven, Connecticut, United States, 06508

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

Publications:

Srihari VH, Breitborde NJ, Pollard J, Tek C, Hyman L, Frisman LK, McGlashan TH, Jacobs S, Woods SW. Public-academic partnerships: early intervention for psychotic disorders in a community mental health center. Psychiatr Serv. 2009 Nov;60(11):1426-8.

Breitborde NJ, Woods SW, Srihari VH. Multifamily psychoeducation for first-episode psychosis: a cost-effectiveness analysis. Psychiatr Serv. 2009 Nov;60(11):1477-83.

Breitborde NJ, Srihari VH, Pollard JM, Addington DN, Woods SW. Mediators and moderators in early intervention research. Early Interv Psychiatry. 2010 May;4(2):143-52.

Saksa JR, Cohen SJ, Srihari VH, Woods SW. Cognitive behavior therapy for early psychosis: a comprehensive review of individual vs. group treatment studies. Int J Group Psychother. 2009 Jul;59(3):357-83. Review.

Responsible Party:	Vinod Srihari, MD, Yale University
ClinicalTrials.gov Identifier:	NCT00309452 History of Changes
Other Study ID Numbers:	0601001013
Study First Received:	March 29, 2006
Last Updated:	July 7, 2010
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:

Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 12, 2012