ProtocolInternational Journal of Clinical Trials
Publication: Caregiver-driven cognitive training program for dementia: a treatment development and feasibility study protocol in Indian population
Int J Clin Trials. 2025;12(2):142-152.DOI10.18203/2349-3259.ijct20251210
Abstract
Background Cognitive training (CT) is an efficacious intervention for promoting experience-dependent neuroplasticity, especially in modifying cognitive decline in neurodegenerative conditions. Despite its immense potential, there exist clinical and logistic challenges in delivering the intervention to the dementia population. Given the cultural context of collectivistic societies like India, where family involvement is integral in illness-related care, a caregiver-supported CT program may overcome current challenges and help promote accessible and affordable dementia care.
Methods The prospective study holds two main objectives that is to develop a caregiver-driven CT program called the Individualized Cognitive Augmentation Regimen for Elderly (iCARE) and to assess the feasibility of iCARE for mild to moderate dementia. The intervention is designed systematically through literature review, item generation, expert validation, field trials, iterative feedback modification and pilot testing. Rooted in principles of neuroplasticity, iCARE targets the core cognitive abilities of attention, executive functions, language and memory. It employs an integrative approach combining bottom-up and top-down strategies, potentially loading on the frontoparietal or central executive networks. The feasibility testing protocol of iCARE aims to build a sustainable model by empowering caregivers as co-therapists through adequate training, thereby reducing the existing treatment gap for dementia in India.
Conclusion The interactive and individualized nature of iCARE may contribute to delaying/slowing cognitive decline in dementia patients while supporting caregivers' well-being. This paper addresses the technical 'what,' 'how,' and 'why' questions in developing and feasibility-testing a culturally specific CT program for dementia. Trial Registration: Clinical Trial Registry of India (7th October 2022) - CTRI/2022/10/046281.
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Affiliations
- Department of Clinical Psychology, National Institute of Mental Health and Neuroscience (NIMHANS), Bangalore, India
- Department of Psychiatry, National Institute of Mental Health and Neuroscience (NIMHANS), Bangalore, India
- Department of Neurology, National Institute of Mental Health and Neuroscience (NIMHANS), Bangalore, India
