First-episode schizophrenia represents a clinically important early phase of illness with varying clinical and cognitive outcomes. Studies have reported that patients with FES often have persistent neurocognitive and social cognitive deficits which significantly influence functional recovery, disability, and quality of life. Pharmacological treatment has limited impact on cognitive dysfunction, making cognitive remediation an important adjunctive intervention. Although growing evidence supports cognitive-based interventions in early psychosis, structured and culturally relevant cognitive remediation programs for first-episode schizophrenia (FES) in the Indian context remain limited. The present protocol outlines a randomized controlled trial to develop and evaluate a culturally appropriate cognitive remediation program for patients with FES. This study is among the first large randomized controlled trials from India to develop and evaluate a culturally tailored cognitive remediation program specifically for FES. To develop a structured cognitive remediation intervention and evaluate its efficacy in improving neurocognition, social cognition, psychopathology, socio-occupational functioning, quality of life, stigma, insight, and disability in patients with FES in remission over six months compared with treatment as usual (TAU). This three-year randomized controlled trial will recruit 300 patients with FES in clinical remission from a tertiary care psychiatric center. FES will be defined as schizophrenia diagnosed as per DSM-5 criteria with duration of illness ≤5 years. Participants will be randomized into intervention and TAU groups (150 each). Both groups will receive standard treatment, while the intervention group will additionally receive a structured 12-week cognitive remediation program targeting attention, memory, executive functioning, and social cognition through therapist-guided and home-based sessions. Assessments will be conducted at baseline, post-intervention, and six-month follow-up using standardized measures of cognition, functioning, quality of life, stigma, and disability. The study is expected to demonstrate improvement in cognitive and functional outcomes among patients receiving cognitive remediation and generate an evidence-based, culturally relevant cognitive rehabilitation protocol for routine clinical use in FES. Cognitive deficits are major determinants of long-term functional outcomes in first-episode schizophrenia. Culturally adapted cognitive remediation integrated with routine care may enhance recovery and reduce disability. This randomized controlled trial will provide evidence for a scalable cognitive intervention model for early schizophrenia in the Indian context
Sahoo et al. (Sun,) studied this question.