Exploratory Evaluation of Staff-Mediated Doll Therapy in Chinese Residential Dementia Care: A Mixed-Methods Cluster Randomized Pilot Trial

Exploratory Evaluation of Staff-Mediated Doll Therapy in Chinese Residential Dementia Care: A Mixed-Methods Cluster Randomized Pilot Trial

This study is a two-phase explanatory sequential mixed-methods study in Chinese residential dementia care. Phase I is a pragmatic 1:1 exploratory pilot cluster randomized trial in six nursing homes in Zhengzhou, China, comparing staff-mediated doll therapy plus routine nursing care with routine nursing care alone among 142 residents with dementia assessed at baseline, 6 weeks, and 12 weeks. Registered primary outcomes are class-specific daily medication-dose trajectories for antipsychotics, anxiolytics, and antidepressants. Secondary and contextual outcomes include behavioral and psychological symptoms of dementia, activities of daily living, cognitive enhancer use, traditional Chinese medicine use, and doll engagement/adherence. Phase II uses semi-structured interviews with staff and family caregivers to explore acceptability, implementation, training needs, cultural fit, and ethical considerations.

Doll therapy is a person-centered, attachment-informed non-pharmacological intervention in which a person living with dementia is offered a lifelike doll and may interact with it by holding, comforting, grooming, or talking to it. This exploratory pilot and feasibility mixed-methods cluster randomized trial evaluates a staff-mediated doll-therapy care package in Chinese nursing homes. Intervention homes receive staff training, a structured introduction to a personal doll, relational engagement during routine care, and ongoing monitoring of resident assent, dissent, distress, and fit. Control homes provide routine nursing care alone. Quantitative assessments are conducted at baseline, 6 weeks, and 12 weeks. Medication-related outcomes are interpreted as indirect health-service and medication-burden signals rather than as direct evidence of prescribing causation. Behavioral, functional, contextual medication, traditional Chinese medicine, and engagement measures are interpreted alongside qualitative interviews with staff and family caregivers to understand implementation, acceptability, cultural fit, and ethical safeguards. Because only six clusters are randomized, the study is intended to generate feasibility information, preliminary effect estimates, and implementation signals rather than definitive clinical-effect evidence.

Inclusion Criteria:

• Age 65 years or older.
• Nursing home resident with a documented clinical diagnosis of dementia recorded in the medical or nursing-home record by a qualified physician using DSM-5, ICD-10, ICD-11, or current Chinese clinical guidelines for dementia and cognitive impairment; where the underlying diagnostic criteria were not specified in the record, the site clinician reconfirmed the diagnosis against DSM-5 criteria before enrollment.
• Adequate visual capacity to recognize a doll at screening.
• Sufficient upper-limb function to hold or caress the doll safely.
• Availability of a legally authorized representative able to provide written informed consent.
• Resident assent whenever appropriate.

Exclusion Criteria:

• Acute medical instability.
• Severe sensory or physical limitations preventing safe participation.
• Severe communication impairment precluding meaningful participation.
• Major psychiatric disorders unrelated to dementia.
• Resident dissent or refusal when assent was appropriate, or safety concerns that made doll interaction unsuitable.