Jirapramukpitak Tawanchai, Supanya Suttha
Institute for Population and Social Research, Mahidol University, Thailand.
Centre of Excellence in Applied Epidemiology, Thammasat University, Thailand.
Lancet Reg Health Southeast Asia. 2025 Jun 10;38:100617. doi: 10.1016/j.lansea.2025.100617. eCollection 2025 Jul.
While specialist-led early intervention services (EIS) have been shown to be effective for early-phase psychosis, the effectiveness of a non-specialist-led EIS is still unclear. The study aims to determine the effectiveness of a low-intensity case management (LICM) programme led by lay health workers for patients during early episodes of psychosis on six-month outcomes compared to usual care (UC) in Bangkok, Thailand.
This pragmatic randomised controlled trial (Lay-CARE) included patients aged ≥18 years with a history of a first or second episode of psychotic disorder residing in the Bangkok Metropolitan Region (Thammasat University hospital's catchment district). Participants were randomised to either LICM or UC group. LICM intervention consisted of family psychoeducation, facilitation of access to services, and home or telephone visits, whereas UC was the baseline of care participants were receiving. The intervention started in October 2020 and ended in May 2021. The 6-month endline assessment started in April 2021 and ended in May 2021. The primary outcome was social functioning measured by the Personal and Social Performance Scale Thai version. Secondary outcomes were symptom severity, service use and medication adherence. The treatment effect size was determined using the average treatment effect (ATE). Due to the nature of the intervention, blinding of participants and assessors was not possible. The trial was registered with the Thai Clinical Trial Registry (TCTR20210509001).
130 participants were randomised to LICM group and 125 to UC group. At the six-month endline, participants in LICM group demonstrated improved socially useful activities (ATE 0.06, 95% CI 0.00-0.13, p = 0.041), less aggressive or disturbing behaviour (ATE -0.17, 95% CI -0.27 to -0.06, p = 0.002), and better self-care (ATE 0.13 95% CI 0.05-0.22, p = 0.003) than participants in UC group. LICM intervention did not affect personal and social relationships, symptom severity, medication adherence, or service use.
In low-resource settings, LICM programme can improve areas of social functioning among patients with early episodes of psychosis over six months.
Health Systems Research Institute (HSRI), Thailand (Grant No. 60-087).
虽然由专科医生主导的早期干预服务（EIS）已被证明对早期精神病有效，但非专科医生主导的EIS的有效性仍不明确。本研究旨在确定在泰国曼谷，由非专业卫生工作者主导的低强度病例管理（LICM）项目对精神病早期发作患者六个月结局的有效性，并与常规护理（UC）进行比较。
这项务实的随机对照试验（Lay-CARE）纳入了年龄≥18岁、有首次或第二次精神病性障碍发作史、居住在曼谷都会区（法政大学医院的服务区域）的患者。参与者被随机分为LICM组或UC组。LICM干预包括家庭心理教育、协助获得服务以及家访或电话随访，而UC是参与者接受的护理基线。干预于2020年10月开始，2021年5月结束。6个月的终末评估于2021年4月开始，2021年5月结束。主要结局是用泰语版个人和社会表现量表测量的社会功能。次要结局是症状严重程度、服务使用情况和药物依从性。治疗效应大小使用平均治疗效应（ATE）来确定。由于干预的性质，不可能对参与者和评估者进行盲法。该试验已在泰国临床试验注册中心注册（TCTR20210509001）。
130名参与者被随机分配到LICM组，125名被分配到UC组。在六个月的终末评估时，LICM组的参与者在社会有益活动方面有所改善（ATE 0.06，95%可信区间0.00-0.13，p = 0.041），攻击或干扰行为较少（ATE -0.17，95%可信区间-0.27至-0.06，p = 0.002），自我护理情况更好（ATE 0.13，95%可信区间0.05-0.22，p = 0.003），均优于UC组的参与者。LICM干预对个人和社会关系、症状严重程度、药物依从性或服务使用没有影响。
在资源匮乏的环境中，LICM项目可以在六个月内改善精神病早期发作患者的社会功能领域。
泰国卫生系统研究所（HSRI）（资助编号60-087）。
