Specialized Treatment Early in Psychosis (STEP)

Not Applicable

Completed

Conditions: Schizophrenia and Disorders With Psychotic Features

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

Registration Number: NCT00309452

Lead Sponsor: Yale University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STEP Care	Medications	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.
STEP Care	Cognitive Behavioral Group Therapy	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.
STEP Care	MFG	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 as usual	Treatment as Usual in the community	Referral to community providers.
STEP Care	Cognitive remediation	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.
STEP Care	Assertive case management	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients Hospitalized	1 year after enrollment

Secondary Outcome Measures

Name	Time	Method
Quality of Life- Heinrich's Quality of Life Scale	12 months	The Quality of Life Scale (QLS) is a 21-item scale rated from a semistructured interview providing information on symptoms and functioning during the preceding 4 weeks. Each item is rated on a seven point scale, and a higher score reflects normal or unimpaired functioning. The range is from 0 to 126. The score reflected is a change from baseline. Total score at 12 months minus total score at baseline. A positive score indicates better mental health.
Adherence- in Contact With Mental Health Services	1 year	Number of participants in contact with mental health services. Collected via self-report.
Medication (Including Metabolic) Side Effects	every 6 months
Vocationally Engaged	1 year after enrollment
Substance Use	every 6 months
Treatment Satisfaction	every 6 months
Relapse	every 6 months	Data was not collected, instead Hospitalization (primary outcome) was used as a proxy
Overall Functioning- Global Assessment of Functioning	12 months	The Global Assessment of Functioning (GAF) is a numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults, e.g., how well or adaptively one is meeting various problems-in-living. A higher score indicates better functioning. The score reported is a change from baseline. The change was calculated as score at 12 months minus score from baseline. A positive score indicates higher functioning.
Subjects Who Committed Self-harm and Violence	12 months	The number of subjects who committed an act of self-harm or violence. This data was collected at 12 months.
Economic Measures Including Service Use, Cost of Care and Forensic Data.	every 6 months	Total annual cost per patient