Specialized Treatment Early in Psychosis (STEP)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Schizophrenia and Disorders With Psychotic Features

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment as usual<br>Referral to community providers. | Other: Treatment as Usual in the community<br>* 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.<br>|
| Experimental: STEP Care<br>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. | Behavioral: Cognitive Behavioral Group Therapy<br>* once per week<br>Behavioral: Cognitive remediation<br>* as needed<br>Drug: Medications<br>* Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.<br>Behavioral: MFG<br>* Multi-Family psychoeducation Group based on the model published by McFarlane et al.<br>Behavioral: Assertive case management<br>* Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Hospitalized |  | 1 year after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse | Data was not collected, instead Hospitalization (primary outcome) was used as a proxy | every 6 months | 
| Overall Functioning- Global Assessment of Functioning | 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. | 12 months | 
| Quality of Life- Heinrich's Quality of Life Scale | 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. | 12 months | 
| Vocationally Engaged |  | 1 year after enrollment | 
| Treatment Satisfaction |  | every 6 months | 
| Adherence- in Contact With Mental Health Services | Number of participants in contact with mental health services. Collected via self-report. | 1 year | 
| Substance Use |  | every 6 months | 
| Subjects Who Committed Self-harm and Violence | The number of subjects who committed an act of self-harm or violence. This data was collected at 12 months. | 12 months | 
| Medication (Including Metabolic) Side Effects |  | every 6 months | 
| Economic Measures Including Service Use, Cost of Care and Forensic Data. | Total annual cost per patient | every 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First episode psychosis, Specialized care, Phase-specific treatment, Schizophrenia, Disorders with psychotic features