Translating evidence for Early Intervention in Psychosis (TRANSLATE) in Low and Lower-Middle Countries (LMIC): Implementation and Evaluation

Research question: What is the clinical utility of establishing an EIP service in terms of rates of engagement with service, remission rates in First Episode Psychosis (FEP) in Low and lower-middle-income countries (LMICs), what clinical factors are associated with Treatment-Resistant Schizophrenia (TRS) and how can these be used to develop a clinical tool to predict the risk of developing TRS in people with FEP? Background: Duration of Untreated Psychosis (DUP) (the period between the onset of psychosis and the initiation of antipsychotic treatment) is twice as long in LMICs compared to High-Income countries (HIC). Prolonged DUP is associated with poor prognosis, premature mortality, disrupted education and poor employment prospects. Early Intervention in Psychosis (EIP) services are well established in HIC and provide treatment at the earliest possible time after diagnosis of FEP, resulting in significantly improved outcomes, but EIP hardly exists in LMIC. TRS is arguably the most disabling psychiatric disorder, but Clozapine (the only licensed medication for TRS) gets delayed for several years, and there is no clinical tool available at present to identify TRS at the earliest possible stage in FEP Aims and objectives: The TRANSLATE (Translating evidence for the Early Intervention in Psychosis) programme aims to establish and evaluate EIP services in Pakistan and Sri Lanka and assemble a cohort of FEP within the EIP service for developing a clinical tool to predict the risk of TRS. Methods and Timelines for delivery: The research plan will consist of three interrelated work packages (WPs): WP-1 (0-16 months): We will develop a model for EIP using theory of change workshops, focus groups and consensus-building workshops. The resulting model will be tested in a small pilot study to refine procedures, measurements, and outcomes WP-2 (16-52 months) will establish EIP in six sites in Pakistan and Sri Lanka. We will recruit 670 people in the service and evaluate the clinical utility of EIP in terms of rates of engagement and remission at one-year follow-up, acceptability, feasibility, and costs to patients, and from the payer and provider perspective. All patients recruited for the EIP and started on antipsychotic treatment will form the cohort for developing and validating clinical a tool for predicting the risk of TRS. The potential predictors for TRS and occurrence of TRS will be measured at baseline and 1,3,6, and 12 months. A similar study will guide the development and internal validity we completed in two UK cohorts. WP3: We will develop a consortium of researchers who will work with PhDs and postdocs to seek external funding to scale up EIP in other countries, build capacity and enhance the impact. The WP will run through the course of the study. Anticipated impact and dissemination: Key outputs from TRANSLATE (EIPS service adapted for LMIC, a prognostic model to predict TRS soon after FEP diagnosis, about 20 clinicians and postgraduates trained in EIP and implementation research, about six publications) will have a substantial academic, societal, and economic impact and will be disseminated widely.