To evaluate the effectiveness of the Indian Digital Neuro-Cognitive module as an intervention for cognitive remediation in substance use disorders: A Randomized control trial

Substance use disorders (SUD) are a significant public health problem, responsible for 5.5% Disability Adjusted Life Year globally. In India the burden due to the neuropsychiatric disorders has been estimated to be 6·2% of all DALYs. SUD impact various dimensions of health and wellbeing, including cognitive deficits. Various SUDs well documented to lead to deficits in various domains including attention and concentration, working memory, reaction time, executive functioning among others. The prevalence of deficits has been found to range from 30-80% in the published literature, and we found that 40-79% among alcohol and opioid use disorders exhibited cognitive deficits in working memory in our study. These cognitive deficits are detrimental, which can increase the risk of relapses, hence worsening the outcome. Also, the presence of these cognitive deficits interferes with day-to-day functioning and the rehabilitation process. Hence it is imperative to offer interventions that are targeted for cognitive remediation. Over the year effective treatment options have been developed for different use disorders. These include both pharmacological and non-pharmacological interventions. However, these interventions are aimed at motivation enhancement, withdrawal management of craving and relapse prevention. None of these interventions are targeted addressing the underlying neurocognitive deficits. Further, the existing and ongoing intervention research in the country have not focused on addressing the cognitive deficits among patients of SUDs. In fact, there are no Indian interventions areavailable for this purpose that have developed and tested for efficacy. This is a major limitation of the existing management the patients with SUD. Thus, there is an unmet need to develop a neurocognitive module which is culturally sensitive and relevant to Indian population, matching the socio-educational background. This Indian digital Neurocognitive module will ensure effectivity and applicability to the Indian populations delivered using mobile based user interface. Subsequently, after the development, the module shall be validated objectively using cognitive assessment and underlying neural mechanisms using EEG cortical source analysis. This shall be done using noninvasive, high density 128 channel Quantitative EEG, ensuring the capture of neural changes during baseline and after the neurocognitive intervention. Using multivariate machine learning algorithms, relevant features will be extracted from high-density EEG and neurocognitive datasets. Subsequently, a composite biomarker will be constructed that reflects cognitive deficits and cognitive remediation