Abstract
BACKGROUND: 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. METHODS: 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). FINDINGS: 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. INTERPRETATION: In low-resource settings, LICM programme can improve areas of social functioning among patients with early episodes of psychosis over six months. FUNDING: Health Systems Research Institute (HSRI), Thailand (Grant No. 60-087).