Doll therapy in residential dementia care in China: protocol for an exploratory pilot and feasibility mixed-methods cluster randomized controlled trial

BACKGROUND: Behavioral and psychological symptoms of dementia commonly drive psychotropic prescribing in residential care. Doll therapy is a person‐centered, attachment‐informed intervention that may reduce distress and support engagement, but evidence from Chinese nursing homes remains limited. This protocol describes an exploratory pilot and feasibility mixed‐methods cluster randomized controlled trial of a staff‐mediated doll‐therapy care package plus routine nursing care versus routine nursing care alone. METHODS AND ANALYSIS: Phase I is a pragmatic, parallel‐group, 1:1 cluster randomized pilot trial in six nursing homes in Zhengzhou, China, targeting 142 residents with dementia. Intervention homes will receive a structured doll‐therapy introduction of eight planned sessions over approximately 15 days, continued access to a personal doll during routine care, staff training, structured interaction, relational engagement, and routine‐care implementation; control homes will provide routine nursing care alone. Assessments occur at baseline, 6 weeks, and 12 weeks. The registered primary outcome is class‐specific mean daily medication dose over 12 weeks for antipsychotics, anxiolytics, and antidepressants, interpreted as an indirect medication‐stewardship signal. The main proximal clinical outcome is total Neuropsychiatric Inventory‐12 score. Secondary and contextual outcomes include Barthel Index, cognitive enhancer use, traditional Chinese medicine use, and structured engagement with the doll. Phase II uses semi‐structured interviews with staff and family caregivers from intervention homes to examine acceptability, implementation, training needs, cultural fit, and ethical considerations. Quantitative analyses will emphasize effect estimates, confidence intervals, cluster‐level summaries, and randomization/permutation‐based robustness checks; qualitative data will be analyzed thematically. DISCUSSION: The study will provide feasibility, acceptability, fidelity, safety, preliminary clinical‐signal, and implementation evidence to inform a future adequately powered cluster trial in Chinese residential dementia care. TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT06506487, ClinicalTrials.gov, NCT06506487. Registered July 16, 2024.