NCT00309452

Specialized Treatment Early in Psychosis (STEP)

Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 16 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia and Disorders With Psychotic Features

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2006-03-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2006-03-31
• Last updated: 2017-02-08
• Results posted: 2016-10-31

Locations

1 site across 1 country: United States