Staged Treatment in Early Psychosis (STEP): A Sequential Multistage Randomized Clinical Trial (SMART) of Interventions for Ultra High Risk (UHR) of Psychosis Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 342
- 试验地点
- 2
- 主要终点
- Global Functioning Scale Score
研究概览
简要总结
A sequential multistage randomised clinical trial (SMART) to produce evidence to guide a step-wise clinical approach for the treatment of ultra high risk patients and reduction of risk for psychosis and other deleterious clinical and/or functional outcomes.
详细描述
The study treatment sequence involves three stages, which are referred to as steps:
Step 1- Support and Problem Solving (SPS)
All trial participants receive SPS treatment in Step 1. Step 1 involves attending weekly-fortnightly SPS sessions over a six week period and the Week 4 and 6 visits will also include an interview with research staff who will assess the symptoms and mental state of participants. These assessments will enable research staff to determine whether the therapy has been effective in improving the participant's symptoms.
Depending on how they respond to the six-week period of treatment in Step 1, participants are randomly assigned to a new treatment arm at the end of Step 1 as detailed below:
Participants who improve with the SPS treatment they receive during Step 1, will be randomised to either monthly SPS treatment for up to one year OR to three-monthly appointments (Month 3, 6, 9 and 12) to monitor their mental state.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Step 1-Regular SPS Therapy
Support and Problem Solving Therapy delivered to all study participants over a six-week period with a minimum of three sessions.
干预措施: Support and Problem Solving Therapy (Behavioral)
Responders- Monthly SPS Therapy
Participants are randomised to receive monthly Support and Problem Solving Therapy for up to 12 months.
干预措施: Support and Problem Solving Therapy (Behavioral)
Responders- 3-monthly monitoring
Participants are randomised to be monitored for risk every 3 months for up to 12 months.
干预措施: 3-monthly monitoring (Behavioral)
Step 2- Regular SPS Therapy
Participants are randomised to receive regular sessions of Support and Problem Solving Therapy, with a minimum of six sessions delivered over an 18-week period.
干预措施: Support and Problem Solving Therapy (Behavioral)
Step 2- Regular CBCM
Participants are randomised to receive regular sessions of Cognitive Behavioural Case Management, with a minimum of six sessions delivered over an 18-week period.
干预措施: Cognitive Behavioural Case Management (Behavioral)
Step 3- Regular CBCM + Fluoxetine
Participants are randomised to receive either Cognitive Behavioural Case Management plus an antidepressant medication for six months .
干预措施: Cognitive Behavioural Case Management (Behavioral)
Step 3- Regular CBCM + Fluoxetine
Participants are randomised to receive either Cognitive Behavioural Case Management plus an antidepressant medication for six months .
干预措施: Fluoxetine (Drug)
Step 3- Regular CBCM+ placebo
Participants are randomised to receive Cognitive Behavioural Case Management plus placebo medication for six months.
干预措施: Cognitive Behavioural Case Management (Behavioral)
Step 3- Regular CBCM+ placebo
Participants are randomised to receive Cognitive Behavioural Case Management plus placebo medication for six months.
干预措施: Placebo (Drug)
结局指标
主要结局
Global Functioning Scale Score
时间窗: 6 months from baseline (end of Step 2)
To test the effect of a sequential treatment approach consisting of SPS/SPS and SPS/CBCM on functioning levels of UHR patients.
次要结局
- Global Functioning Scale Score(12 months from baseline (end of Step 3))
- Comprehensive Assessment of At Risk Mental State score(1.5, 6, 12 and 24 months from baseline)
- Scale for Assessment of Negative Symptoms score(1.5, 6, 12 and 24 months from baseline)
- Montgomery Asberg Depression Rating Scale score(1.5, 6, 12 and 24 months from baseline)