Specialized Treatment Early in Psychosis (STEP)

NCT00309452 | Completed Results DMC

• 1 other identifier: 0601001013
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia and Disorders With Psychotic Features

Keywords

First episode psychosis; Specialized care; Phase-specific treatment; Schizophrenia; Disorders with psychotic features

Outcome Measures

Primary Outcomes (1)

• Number of Patients Hospitalized

  1 year after enrollment

Secondary Outcomes (10)

• Relapse

  every 6 months

• Overall Functioning- Global Assessment of Functioning

  12 months

• Quality of Life- Heinrich's Quality of Life Scale

  12 months

• Vocationally Engaged

  1 year after enrollment

• Treatment Satisfaction

  every 6 months

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

Referral to community providers.

Other: Treatment as Usual in the community

STEP Care

EXPERIMENTAL

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

Interventions

Cognitive Behavioral Group Therapy BEHAVIORAL

once per week

STEP Care

Cognitive remediation BEHAVIORAL

as needed

STEP Care

Medications DRUG

Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.

STEP Care

MFG BEHAVIORAL

Multi-Family psychoeducation Group based on the model published by McFarlane et al.

STEP Care

Assertive case management BEHAVIORAL

Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports.

STEP Care

Treatment as Usual in the community OTHER

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.

Treatment as usual

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (12)

• 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.

  PMID: 19880454 BACKGROUND

• 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/ps.2009.60.11.1477.

  PMID: 19880465 BACKGROUND

• 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.

  PMID: 20536970 BACKGROUND

• 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.

  PMID: 19548785 BACKGROUND

• 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.

  PMID: 22642728 BACKGROUND

• 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.

  PMID: 22929869 BACKGROUND

• 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.

  PMID: 21762843 BACKGROUND

• 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/ps.62.8.pss6208_0878.

  PMID: 21807825 RESULT

• 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.

  PMID: 22060947 RESULT

• 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.

  PMID: 22445463 RESULT

• 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.

  PMID: 21242060 RESULT

• 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.

  PMID: 25639994 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia

Interventions

Cognitive Remediation; Dosage Forms; Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Results Point of Contact

• Title: Vinod H. Srihari
• Organization: Yale University

vinod.srihari@yale.edu

2039747816

Study Officials

• Vinod H Srihari, M.D.

  Yale University School of Medicine & Connecticut Mental Health Center

  PRINCIPAL INVESTIGATOR

• Scott Woods, M.D.

  Yale University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2006
• First Posted: March 31, 2006
• Study Start: March 1, 2006
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 8, 2017
• Results First Posted: October 31, 2016

Record last verified: 2016-12

Locations

US (1)