Specialized Treatment Early in Psychosis (STEP)

NCT00309452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-02-08

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Vinod H Srihari, M.D. · Yale University School of Medicine & Connecticut Mental Health Center

  • Scott Woods, M.D. · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00309452 on ClinicalTrials.gov