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

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:

Genetics Home Reference related topics: schizophrenia

MedlinePlus related topics: Mental Disorders 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 ]


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.

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:

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

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:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Dodds TJ, Phutane VH, Stevens BJ, Woods SW, Sernyak MJ, Srihari VH. Who is paying the price? Loss of health insurance coverage early in psychosis. Psychiatr Serv. 2011 Aug;62(8):878-81. doi: 10.1176/appi.ps.62.8.878.

Perez VB, Ford JM, Roach BJ, Woods SW, McGlashan TH, Srihari VH, Loewy RL, Vinogradov S, Mathalon DH. Error monitoring dysfunction across the illness course of schizophrenia. J Abnorm Psychol. 2012 May;121(2):372-87. doi: 10.1037/a0025487. Epub 2011 Nov 7.

Breitborde NJ, Kleinlein P, Srihari VH. Self-determination and first-episode psychosis: associations with symptomatology, social and vocational functioning, and quality of life. Schizophr Res. 2012 May;137(1-3):132-6. doi: 10.1016/j.schres.2012.02.026. Epub 2012 Mar 22.

Phutane VH, Tek C, Chwastiak L, Ratliff JC, Ozyuksel B, Woods SW, Srihari VH. Cardiovascular risk in a first-episode psychosis sample: a 'critical period' for prevention? Schizophr Res. 2011 Apr;127(1-3):257-61. doi: 10.1016/j.schres.2010.12.008. Epub 2011 Jan 15.

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. doi: 10.1176/appi.ps.60.11.1426.

Breitborde NJ, Woods SW, Srihari VH. Multifamily psychoeducation for first-episode psychosis: a cost-effectiveness analysis. Psychiatr Serv. 2009 Nov;60(11):1477-83. doi: 10.1176/appi.ps.60.11.1477.

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. doi: 10.1111/j.1751-7893.2010.00177.x. Review.

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. doi: 10.1521/ijgp.2009.59.3.357. Review.

Breitborde NJ, Srihari VH, Woods SW. Review of the operational definition for first-episode psychosis. Early Interv Psychiatry. 2009 Nov;3(4):259-65. doi: 10.1111/j.1751-7893.2009.00148.x. Review.

Srihari VH, Shah J, Keshavan MS. Is early intervention for psychosis feasible and effective? Psychiatr Clin North Am. 2012 Sep;35(3):613-31. doi: 10.1016/j.psc.2012.06.004. Epub 2012 Jul 21. Review.

Ozkan B, Phutane V, Jonas E, Tek C, Srihari V. Hoofbeats and zebras: neurodegenerative disorder presenting as a "first episode" of psychosis. Gen Hosp Psychiatry. 2011 Jul-Aug;33(4):412.e1-3. doi: 10.1016/j.genhosppsych.2011.03.011. Epub 2011 May 5.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Srihari VH, Tek C, Kucukgoncu S, Phutane VH, Breitborde NJ, Pollard J, Ozkan B, Saksa J, Walsh BC, Woods SW. First-Episode Services for Psychotic Disorders in the U.S. Public Sector: A Pragmatic Randomized Controlled Trial. Psychiatr Serv. 2015 Jul;66(7):705-12. doi: 10.1176/appi.ps.201400236. Epub 2015 Feb 2.


Responsible Party:	Vinod Srihari, Associate Professor, Yale University
ClinicalTrials.gov Identifier:	NCT00309452 History of Changes
Other Study ID Numbers:	0601001013
Study First Received:	March 29, 2006
Last Updated:	September 17, 2013
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 September 28, 2016

Specialized Treatment Early in Psychosis (STEP) (STEP)