Access, Detection and Psychological Treatments
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Research Stream 1: Treatment and Cost Effectiveness Primary outcome measure: (i) Time to conversion.
研究概览
简要总结
Schizophrenia is one of society's most costly medical conditions and the most severe among psychiatric disorders. One of the most important and exciting new concepts in psychiatry is that detection and intervention very early in the course of schizophrenia offers what may be the field's best practical hope for realizing substantive improvements in the outcome of schizophrenia or schizophrenia spectrum disorders. Thus, we propose a five year program that focuses on three interconnected major research streams: (1) an evaluation of the effectiveness and cost-effectiveness of a model-driven psychological intervention in preventing or delaying the onset of a psychotic illness; (2) a qualitative study of the pathways to mental health at this time of very high risk; and (3) an exploration of the burden to the healthcare and informal caregiver systems associated with this high risk population.
详细描述
Research Stream 1:
Treatment and Cost Effectiveness The primary aim of Stream 1 is to evaluate the effectiveness of a model-driven psychological intervention, CBT in preventing or delaying the onset of a psychotic illness and to evaluate the effectiveness of CBT in reducing presenting concerns in a sample of help-seeking individuals who have been operationally defined to be at ultra high risk of developing a psychotic illness. CBT will be compared to supportive therapy (ST). We will also examine the cost-effectiveness of a preventive approach. Using a cost-consequence approach, we will examine the cost-effectiveness of CBT versus supportive therapy in addressing psychosis in the "ultra high risk" phase from the perspective of the payer (i.e., the Ministry of Health and Long-Term Care). The hypotheses are:
(i) The time of conversion will be significantly longer for those in the CBT group compared to those in the ST condition.
(ii) The mean level of attenuated psychotic symptoms (SOPS ratings ) will be significantly lower in the CBT group compared to the ST group at the completion of the intervention and at each follow up point.
(iii) Levels of risk factors (measured by CMRS & GHQ2) will be significantly lower in the CBT group compared to the ST group at the completion of the intervention and at each follow up point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 12-30 years·
- •Meeting criteria for an "at risk mental state" based on one or more of the 3 Criteria of Prodromal Symptoms (COPS criteria) with severity as determined by ratings on the Scale of Prodromal Symptoms (SOPS) or the criteria for attenuated symptoms of the early prodromal state defined by the presence of at least two of 9 symptoms on the Bonn Scale for the Assessment of Basic Symptoms that have been demonstrated to have the best positive predictive value of developing schizophrenia (Klosterkötter et al., 2001). These criteria for the early prodromal state course are currently used in the multi-site European Prediction of Psychosis Study (EPOS) (Birchwood et al., 2002).
排除标准
- •Meets criteria for current or lifetime axis I psychotic disorder.·
- •Meets DSM-IV criteria for an Axis 1 disorder where in the judgment of the evaluating clinician the diagnostic prodromal symptoms are clearly caused by the Axis 1 disorder. Note that, except for bipolar and psychotic disorders and a current major depression other DSM-IV disorders will not be exclusionary (e.g. substance abuse or dependence disorder, major depression, anxiety disorders, Axis II Disorders) as long as the disorder does not account for the diagnosis of prodromal symptoms.·
- •Use of substances where in the judgment of the evaluating clinician, the diagnostic prodromal symptoms are substance-induced.
- •Prior history of treatment with an antipsychotic for the current presenting symptoms or for any previous episode of psychotic symptoms.
- •Impaired intellectual functioning (IQ< than 70).
- •Past or current history of a clinically significant central nervous system disorder which may confound or contribute to prodromal symptoms.
结局指标
主要结局
Research Stream 1: Treatment and Cost Effectiveness Primary outcome measure: (i) Time to conversion.
时间窗: 18 months
Research Stream 2: Pathways to Care Primary outcome measure: Pathway to care interview
时间窗: 18 months
Research Stream 3: Costs of Caring in Psychosis Primary outcome measure: (i) Time to conversion, (ii) costs of formal and informal care giving.
时间窗: 18 months
次要结局
未报告次要终点