Specialized Treatment Early in Psychosis (STEP)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Schizophrenia and Disorders With Psychotic Features |
Behavioral: Cognitive Behavioral Group Therapy Behavioral: Cognitive remediation Drug: Medications Behavioral: MFG Behavioral: Assertive case management Other: Treatment as Usual in the community |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis. |
- Rehospitalization measured every 6 months for 5 years. [ Time Frame: Assessed every 6 months ] [ Designated as safety issue: No ]
- Relapse [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- Overall functioning [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- Education and employment status [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- Treatment satisfaction [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- Adherence [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- Substance use [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
- Adverse events (including self-harm and violence) [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
- Medication (including metabolic) side effects [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]
- Economic measures including service use, cost of care and forensic data. [ Time Frame: every 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2006 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Treatment as usual
Referral to community providers.
|
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.
|
|
Experimental: STEP Care
Integrated and comprehensive treatment provided by a specialized team in a public mental health center.
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Vinod Srihari, MD | (203) 974-7816 | vinod.srihari@yale.edu |
| Contact: Scott Woods, M.D. | (203) 974-7300 | scott.woods@yale.edu |
| United States, Connecticut | |
| Connecticut Mental Health Center | Recruiting |
| New Haven, Connecticut, United States, 06508 | |
| Principal Investigator: | Vinod H Srihari, M.D. | Yale University School of Medicine & Connecticut Mental Health Center |
| Study Chair: | Scott Woods, M.D. | Yale University |
More Information
Additional Information:
Publications:
| Responsible Party: | Vinod Srihari, Associate Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT00309452 History of Changes |
| Other Study ID Numbers: | 0601001013 |
| Study First Received: | March 29, 2006 |
| Last Updated: | August 9, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Yale University:
|
First episode psychosis Specialized care Phase-specific treatment Schizophrenia Disorders with psychotic features |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on May 16, 2013