Specialized Treatment Early in Psychosis (STEP)

Yale University

Status: Completed

Conditions: Schizophrenia and Disorders With Psychotic Features

Treatments: Behavioral: Assertive case management; Drug: Medications; Other: Treatment as Usual in the community; Behavioral: Cognitive remediation; Behavioral: MFG; Behavioral: Cognitive Behavioral Group Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00309452

0601001013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Treatment as usual

Active Comparator group

Description:

Referral to community providers.

Treatment:

Other: Treatment as Usual in the community

STEP Care

Experimental group

Description:

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.

Treatment:

Behavioral: Assertive case management

Behavioral: Cognitive remediation

Behavioral: Cognitive Behavioral Group Therapy

Drug: Medications

Behavioral: MFG