NCT06071858招募中不适用
Cluster Randomized Trial of Enhanced Coordinated Specialty Care (CSC 2.0) for Early Psychosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 10
- 主要终点
- Months Engaged in Care
研究概览
简要总结
The goal of this clinical trial is to compare engagement in treatment in coordinated specialty care (CSC) to five extra care elements (CSC 2.0) in first-episode psychosis. The main question it aims to answer is:
• Does the addition of certain elements of care increase the number of visits in treatment for first-episode psychosis?
Participants will either:
- Receive care as usual (CSC) or
- Receive care as usual (CSC) plus five additional care elements (CSC 2.0):
- Individual peer support
- Digital outreach
- Care coordination
- Multi-family group therapy
- Cognitive remediation
Researchers will compare the standard of care (CSC) to CSC 2.0 to see if participants receiving CSC 2.0 have more visits to their clinic in their first year.
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People undergoing an intake evaluation to CSC for first-episode psychosis in one of the following outpatient clinics:
- •McLean Hospital OnTrack (OnTrack Clinic)
- •Massachusetts General Hospital (FEPP Clinic)
- •Boston Medical Center (WRAP Clinic)
- •Cambridge Health Alliance (RISE Clinic)
- •UMass Memorial Health Care (STEP Clinic)
- •ServiceNet (PREP West)
排除标准
- 未提供
结局指标
主要结局
Months Engaged in Care
时间窗: 12 months following clinic intake
Number of months each participant had ≥4 visits in a 12-month period
次要结局
- Duration of Treatment(Up to 12 months - measured as time between clinic intake and detachment)
- Clinic Visit Number(12 months following clinic intake)
- Proportion in Arm Still in Clinic(12 months following clinic intake)
- Clinic Visit Type(12 months following clinic intake)
研究者
Dost Ongur
Director, LEAP Center
Mclean Hospital
研究点 (10)
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