Specialized Treatment Early in Psychosis (STEP)

• 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 ]

• Relapse
• Overall functioning
• Quality of life
• Education and employment status
• Treatment satisfaction
• Adherence
• Substance use
• Adverse events (including self-harm and violence)
• Medication (including metabolic) side effects
• Economic measures including service use, cost of care and forensic data.

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.

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.

• 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.

• Active Comparator: Treatment as usual
  Referral to community providers.
  Intervention: Other: Treatment as Usual in the community
• Experimental: STEP Care
  Integrated and comprehensive treatment provided by a specialized team in a public mental health center.
  Interventions:

  • Behavioral: Cognitive Behavioral Group Therapy
  • Behavioral: Cognitive remediation
  • Drug: Medications
  • Behavioral: MFG
  • Behavioral: Assertive case management

• Srihari VH, Breitborde NJ, Pollard J, Tek C, Hyman L, Frisman LK, McGlashan TH, Jacobs S, Woods SW. Public-academic partnerships: early intervention for psychotic disorders in a community mental health center. Psychiatr Serv. 2009 Nov;60(11):1426-8.
• Breitborde NJ, Woods SW, Srihari VH. Multifamily psychoeducation for first-episode psychosis: a cost-effectiveness analysis. Psychiatr Serv. 2009 Nov;60(11):1477-83.
• Breitborde NJ, Srihari VH, Pollard JM, Addington DN, Woods SW. Mediators and moderators in early intervention research. Early Interv Psychiatry. 2010 May;4(2):143-52.
• Saksa JR, Cohen SJ, Srihari VH, Woods SW. Cognitive behavior therapy for early psychosis: a comprehensive review of individual vs. group treatment studies. Int J Group Psychother. 2009 Jul;59(3):357-83. Review.

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