An interventional study of Doll Therapy in Dementia, sponsored by University of Malaya. Completed at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by University of Malaya · Not applicable, Interventional, and Supportive care
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.
2,172 studies on the registry are indexed under Dementia; 541 are open to participants now.
This study's enrollment of 142 is above the median of 83 across 1,629 interventional studies indexed under Dementia.
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Exclusion Criteria:
Residents in intervention homes received routine nursing care plus a staff-mediated doll-therapy care package. The package included staff training, a structured doll-therapy introduction with eight planned sessions over approximately 15 days, continued access to a personal doll during routine care, structured interaction and relational engagement, and ongoing monitoring of resident assent, dissent, distress, and fit.
Behavioral: Doll Therapy
Residents in control homes received routine nursing care alone. Control homes did not receive study-provided dolls or structured doll-therapy training during the study period.
Staff-mediated doll therapy is a person-centered, attachment-informed non-pharmacological care package in which trained nursing-home staff introduce a lifelike doll respectfully, support resident-led interaction, monitor assent and dissent, and provide continued access to a personal doll during routine care. The intervention included eight planned introductory sessions over approximately 15 days, structured interaction, relational engagement, and implementation within ordinary nursing-home care.
Change in Class-Specific Daily Medication Dose
This primary outcome assesses class-specific mean daily medication-dose trajectories for antipsychotics, anxiolytics, and antidepressants over 12 weeks. Antipsychotics are expressed as chlorpromazine-equivalent daily dose, anxiolytics as diazepam-equivalent daily dose, and antidepressants using the WHO defined daily dose framework. Changes are compared between doll therapy plus routine nursing care and routine care alone.
Time frame: 12 weeks
Change in Behavioral and Psychological Symptoms of Dementia (BPSD)
This secondary outcome measure will evaluate the change in behavioral and psychological symptoms of dementia (BPSD) using the Neuropsychiatric Inventory (NPI-12). This inventory includes 12 domains such as delusions, hallucinations, agitation/aggression, depression, anxiety, and others. The scores will be measured and compared between the intervention and control groups. The NPI-12 scores range from 0 to 144, with higher scores indicating more severe symptoms.
Time frame: 12 weeks
Change in Activities of Daily Living (ADL)
This secondary outcome measure will assess the change in activities of daily living (ADL) using the Chinese version of the Barthel Index of ADL. This index measures the functional independence of participants in performing daily activities such as feeding, bathing, dressing, toileting, transferring, and walking. The scores will be measured and compared between the intervention and control groups. The Barthel Index scores range from 0 to 100, with higher scores indicating better functional independence.
Time frame: 12 weeks
Change in Cognitive Enhancer Use
Cognitive enhancer use is evaluated as a secondary/contextual medication outcome over 12 weeks and expressed in donepezil-equivalent daily dose where applicable. Changes are compared between doll therapy plus routine nursing care and routine care alone.
Time frame: 12 weeks
Change in Traditional Chinese Medicine Use
Traditional Chinese medicine use is summarized as a context-specific composite score incorporating formula complexity, dosage, frequency, and duration. This contextual outcome is evaluated over 12 weeks and compared between doll therapy plus routine nursing care and routine care alone.
Time frame: 12 weeks
Doll Engagement and Adherence
Within intervention homes, structured session records document doll acceptance, session attendance, resident assent or dissent, and sustained engagement with the doll. Engagement and adherence are summarized descriptively and used for contextual interpretation and per-protocol sensitivity analysis.
Time frame: 12 weeks
Plan to share: Yes — De-identified quantitative analysis-ready data underlying the reported results and analytic code may be shared with qualified researchers on reasonable request. Because the dataset contains potentially identifiable nursing-home clinical information, data will not be posted publicly. The qualitative coding framework may also be available on reasonable request.
Supporting information: Study protocol, Sap, Icf, Analytic code
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Malaya