Clinical trial NCT00309452: Specialized Treatment Early in Psychosis (STEP)
Official title: Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia and Disorders With Psychotic Features
Keywords: First episode psychosis
Specialized care
Phase-specific treatment
Schizophrenia
Disorders with psychotic features
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2006-03-31
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Number of Patients Hospitalized
timeFrame: 1 year after enrollment
Secondary outcomes:
measure: Relapse
timeFrame: every 6 months
measure: Overall Functioning- Global Assessment of Functioning
timeFrame: 12 months
measure: Quality of Life- Heinrich's Quality of Life Scale
timeFrame: 12 months
measure: Vocationally Engaged
timeFrame: 1 year after enrollment
measure: Treatment Satisfaction
timeFrame: every 6 months
measure: Adherence- in Contact With Mental Health Services
timeFrame: 1 year
measure: Substance Use
timeFrame: every 6 months
measure: Subjects Who Committed Self-harm and Violence
timeFrame: 12 months
measure: Medication (Including Metabolic) Side Effects
timeFrame: every 6 months
measure: Economic Measures Including Service Use, Cost of Care and Forensic Data.
timeFrame: every 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University School of Medicine & Connecticut Mental Health Center
name: Vinod H Srihari, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Scott Woods, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.