A family caregiver delivers a structured 30-minute mental stimulation session to a relative with dementia, three times a week for 25 weeks, using a manual and DVD of music and famous faces. This matters because group-based Cognitive Stimulation Therapy (CST) is known to improve cognition and quality of life for people with dementia, but many cannot attend group sessions due to mobility, transport, or personal preference. No equivalent one-to-one programme delivered by a family carer has been rigorously tested. The trial will compare individual CST against standard care in 306 people with dementia, measuring cognition, quality of life, and cost-effectiveness from both health service and societal perspectives. If the programme works, it would give families a practical, low-cost tool to maintain a relative’s mental function at home, without requiring clinic visits. Carers receive standardised training and up to ten hours of support, including phone calls and home visits. The research also examines how delivering the therapy affects the carer’s own wellbeing and their relationship with the person they care for.
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BACKGROUND: Cognitive Stimulation Therapy (CST) as developed by this research group (Spector et al., 2003) is an effective 14 session group programme which improves cognition and quality of life for people with dementia and has been recommended by the NICE dementia guidelines (NICE, 2006). DESIGN: Multicentre, pragmatic, single blind, randomised, 2 treatment arm (individual CST vs treatment as usual), controlled clinical trial over 26 weeks. The individual CST programme will be based on a modified CST manual the updated CST review, and a focus group consultation with people with dementia and their carers. The treatment as usual group (TAU) will not receive any additional intervention. Assessments will be: baseline (pre-CST); 13 weeks and 26 weeks. TARGET POPULATION: People with dementia and their carers in community settings including memory clinics, the voluntary sector and day care. HEALTH TECHNOLOGY BEING ASSESSED: Individual CST would be delivered by the family caregiver for 30 minutes, 3 times a week over 25 weeks . All sessions will be described in the manual and an accompanying DVD will have other material for each session such as music and visual cues (eg famous faces). Carers will receive a standardised training, and receive up to ten hours support including telephone support (initially weekly) and 3 visits. Qualitative interviews will be used to investigate the impact on the carer role and carer relationship OUTCOMES: Primary outcome cognition and quality of life. Primary economic evaluation: cost-effectiveness analysis from a health and social care perspective and also a societal perspective, looking at comprehensive costs. SAMPLE SIZE: This analysis will be based on intention to treat for the primary outcome cognition. A sample size of 260 will have 80% power to detect a SMD of 0.35 using a two group t-test with a 0.05 significance level comparing the individual CST and the TAU groups. Assuming 15% attrition we propose to recruit 306 people with dementia.
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