A Prospective, Open Label, Quasi-Experimental Study of Adult Patients With Schizophrenia or Schizoaffective Disorder Within Five Years of Diagnosis Who Will Receive SEEC Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- High Intensity Service Utilization Rate
研究概览
简要总结
The purpose of this study is to describe relapse rates among participants receiving services in the SEEC program high intensity resource use. For purposes of this study, relapse will be defined as: Psychiatric hospitalization; Psychiatric emergency department visits; Ambulatory acute services (Partial Hospitalization Program, Intensive Outpatient Program, Crisis House stay).
详细描述
Schizophrenia is a severe mental illness that is one of the leading causes of long-term disability in the world. Recognizing the need for improved early treatment for participants diagnosed with Schizophrenia or Schizoaffective Disorder, a model was created for a "sustainable early episode clinic, SEEC." The goal of the SEEC model is to provide early intense intervention in 3 phases, with an ongoing maintenance phase, enabled by technology, resulting in improved participant outcomes and reduced long-term economic and social burden of schizophrenia. This study will last for up to a 36-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants
- •Participants must be at least 18 years or older
- •Participants within 5 years of a clinical diagnosis of Schizophrenia or Schizoaffective disorder made by a clinician with understanding of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for these disorders
- •Participants must be able to speak, read, and understand English
- •Participants must sign an informed consent form
- •Inclusion Criteria - Caregivers
- •Caregivers must be 18 years or older Caregivers must also be willing to attend the multi-family psychoeducation group series (Phase I)
- •Caregivers must be willing to participate in monthly family therapy and/or monthly phone contact with staff for the duration of the study
- •Caregivers must sign informed consent form
排除标准
- •Participants
- •Co-occurring developmental disabilities
- •Receiving electroconvulsive therapy
- •Primary substance use disorder
- •On permanent conservatorship
- •Unable to complete baseline assessments due to acuity of psychiatric symptoms
- •Exclusion Criteria - Caregivers
- •Caregivers who refuse to participate in the psychoeducation series of Phase 1
- •Caregivers who refuse monthly family therapy/phone contact with staff will be excluded
- •Caregiver is mentally or physically incapable of adequately performing the required study procedures, as determined by treatment team
- •Caregiver is an employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employee or the investigator
研究组 & 干预措施
Sustainable Early Episode Clinic Model of Care
The model of care given in the sustainable early episode clinic study, provides early intense intervention, with an ongoing maintenance phase in an outpatient setting.
干预措施: Sustainable Early Episode Clinic Model of Care (Behavioral)
结局指标
主要结局
High Intensity Service Utilization Rate
时间窗: Baseline up to 36 months
The rate of high intensity service utilization that is count per unit of time for mental health services will be reported. It is evaluated as the number of psychiatric hospitalizations, behavioral health emergency department visits, and number of times referred to a partial hospitalization program (PHP), intensive outpatient program (IOP), or Crisis Unit.
次要结局
- Overall Healthcare Utilization Rate(Baseline up to 36 months)
- Change from Baseline in Clinician-Rated Dimensions of Psychosis Symptom and Severity (CRDPSS) Scale(Baseline up to 36 months)
- Change from Baseline in Clinical Global Impressions Scale (CGI-S)(Baseline up to 36 months)
- Change from Baseline in Personal and Social Performance (PSP) Scale(Baseline up to 36 months)
- Change from Baseline in Perceived Family Burden Scale (PFBS)(Baseline up to 36 months)
- Heinrichs-Carpenter Quality of Life Scale (QLS)(Baseline up to 36 months)