Integrated Care in Early Psychosis (ICEP Study): a 12-month Quasi Experimental Study With Historic Control Group
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Remission of psychosocial functioning
研究概览
简要总结
Improvement of clinical long-term outcome through the implementation of early detection and intervention within a specialized network of integrated care (ACT and hometreatment) for adolescents and young adults with a first episode of psychosis between 12 and 29 years.
详细描述
The trial is carried out at the Psychosis Center of the Department of Psychiatry and Psychotherapy and the Department of Child and Adolescent Psychiatry at the University Medical Center Hamburg-Eppendorf (UKE), which has the responsibility to treat all Child, adolescent and adult patients within its catchment area of approximately 300.000 habitants.
The IC model was implemented into a network of the Psychosis Center of the University hospital (UKE), private psychiatrists and psychologists of the UKE catchment area and other outpatient facilities. As such, following health care structures are part of the model and could be used by each patients and its relatives according to need:
Specialized inpatient units with attached day-clinics for psychotic disorders; Acute inpatient units of both Departments; Specialized psychosis outpatient center with a variety of diagnosis-specific evidence-based individual- and group therapies, low-threshold offers to promote day structure (e.g., cooking, sport or art groups), an early detection and intervention service with a mobile early detection team with professionals from the child- and youth and adult psychiatry, possibility of peer-to-peer and relatives-to-relatives counseling, relative groups.
A multidisciplinary assertive community treatment (ACT) team, which was implemented according to guidelines of the Assertive Community Treatment Association and according to the Dartmouth Assertive Community Treatment Scale (DACTS). Compared to the traditional ACT model there are two important differences: (1) While traditional ACT models have a responsibility for patients with severe and persistent mental illness (SPMI) patients independent from the underlying diagnosis, the present model solely focus on patients with psychotic disorders; (2) The fidelity of the ACT team was further increased by composing a team of highly educated psychosis experts (i.e. consultant psychiatrists, psychiatrists, psychologists, nurses, social worker). Members of the ACT team received diagnosis-specific training in pharmacotherapy, cognitive behavioral (CBT), dynamic, and/or family psychotherapy.
A specialized day-clinic for first-episode psychosis patients in the age range of 15-29 years managed by the child- and youth and adult psychiatry; A working support outpatient center with outpatient and day-clinic treatment facilities; 20 private psychiatrists participate in the treatment network of the IC model (their duties and responsibilities are described below).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 29 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male/female, age 12-29, adequate knowledge of German language
- •Early psychosis critria according to Lewis, Tarrier, & Haddock, 2002 fullfilled: first or second hospitalisation for psychosis during the past 2 years, duration of illness (psychosis)≤2 years
- •Diagnosis chriteria according to DSM-IV TR fullfilled for schizophrenia(295.xx including all subtypes), schizophreniform psychosis(295.40), schizoaffektive disorder(295.70), delusional disorder (297.1), brief psychotic episode 298.8), psychotic disorder (298.9), bipolar I disorder (including 296.44, 296.54 and 296.64) and major depression with psychotic symptoms (296.24 and 296.34).
排除标准
- •One of the following diagnoses according to DSM-IV TR:
- •Alkcohol- or substance induced psychosis (z.B. 291.3, 291.5, 292.xx: -.11 or -.12); Psychosis according to somatic disorder(z.B. 293.0, 290.12, 290.20, 290.42, 293.89); pregnancy.
结局指标
主要结局
Remission of psychosocial functioning
时间窗: 12 months
The primary outcome is the rate (yes / no in %) of patients with combined psycho-functional remission at 12 months study endpoint in the intervention (IC) versus the control condition (CC). The primary objective criterion was regarded as met when the following conditions were fulfilled: 1. Symptomatic remission according to the criterion by Andreasen et al. \[75\]. In the ACCESS III study the criterion was regarded as fulfilled when a symptomatic remission was present at T2 (6 months) and T3 (12 months) and there had been no worsening of symptoms on one of the items in between. 2. Functional remission pursuant to the criterion by Albert et al. \[76\]. In the ACCESS III study the criterion was regarded as fulfilled when a functional remission was present at T2 (6 months) and T3 (12 months) and there had been no worsening of functioning in between.
次要结局
未报告次要终点
研究者
Prof. Dr. med. Martin Lambert
Professor, MD
Universitätsklinikum Hamburg-Eppendorf
