Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Patients Hospitalized
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment as usual
Referral to community providers.
干预措施: Treatment as Usual in the community (Other)
STEP Care
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.
干预措施: Cognitive Behavioral Group Therapy (Behavioral)
STEP Care
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.
干预措施: Cognitive remediation (Behavioral)
STEP Care
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.
干预措施: Medications (Drug)
STEP Care
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.
干预措施: MFG (Behavioral)
STEP Care
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.
干预措施: Assertive case management (Behavioral)
结局指标
主要结局
Number of Patients Hospitalized
时间窗: 1 year after enrollment
次要结局
- Quality of Life- Heinrich's Quality of Life Scale(12 months)
- Adherence- in Contact With Mental Health Services(1 year)
- 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)
- Overall Functioning- Global Assessment of Functioning(12 months)
- Subjects Who Committed Self-harm and Violence(12 months)
- Economic Measures Including Service Use, Cost of Care and Forensic Data.(every 6 months)