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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
once per week
as needed
Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.
Connecticut Mental Health Center
New Haven, Connecticut, United States
Number of Patients Hospitalized
Time frame: 1 year after enrollment
Relapse
Data was not collected, instead Hospitalization (primary outcome) was used as a proxy
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Vocationally Engaged
Time frame: 1 year after enrollment
Treatment Satisfaction
Time frame: every 6 months
Adherence- in Contact With Mental Health Services
Number of participants in contact with mental health services. Collected via self-report.
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Multi-Family psychoeducation Group based on the model published by McFarlane et al.
Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports.
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.
Time frame: 1 year
Substance Use
Time frame: 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.
Time frame: 12 months
Medication (Including Metabolic) Side Effects
Time frame: every 6 months
Economic Measures Including Service Use, Cost of Care and Forensic Data.
Total annual cost per patient
Time frame: every 6 months