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NCT07907042
Effects of Doll Therapy on Apathy and Activities of Daily Living Initiation Deficits in Older Adults With Dementia
Conditions: Dementia
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 106
Sponsor: Xinyu ZHANG
Location: Guangzhou Geriatric Hospital Guangdong Guangzhou
Summary
Dementia is a major health challenge associated with population aging. As dementia progresses, patients often experience a decline in their ability to perform basic activities of daily living (BADL), such as dressing and personal hygiene, leading to increased dependence on caregivers. Apathy, characterized by reduced motivation, interest, and initiative, is a common symptom of dementia and may contribute to difficulties in initiating daily activities.
Doll therapy is a non-pharmacological intervention that involves guided interaction with dolls to promote emotional engagement, motivation, and participation in activities. Previous studies suggest that doll therapy may help alleviate apathy and improve behavioral symptoms in patients with dementia. However, its effects on the initiation of basic daily activities remain unclear.
This study aims to evaluate the effectiveness of doll therapy in improving apathy and basic activities of daily living among older adults with dementia. Participants will be randomly assigned to either a doll therapy group or a usual care group. The intervention will last for 2 weeks, and outcomes will be assessed at baseline, Week 2 (end of intervention), and Week 4 (follow-up).
The primary outcome is the severity of apathy. Secondary outcomes include basic activities of daily living, quality of life, and neuropsychiatric symptoms.
The study hypothesizes that doll therapy will reduce apathy and improve the ability to initiate and perform basic daily activities in older adults with dementia compared with usual care.
Eligibility Criteria
Inclusion Criteria:
1. Aged 60 years or older.
2. Diagnosed with Alzheimer's disease or other types of dementia according to the International Classification of Diseases, 10th Revision (ICD-10), or with major neurocognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
3. Hospitalization duration exceeding 4 weeks.
4. Apathy Evaluation Scale-Informant Version (AES-I) score ≥33.
5. Not participating in any other clinical research trials.
6. Voluntary participation with written informed consent provided by the participant or their legally authorized representative.
Exclusion Criteria:
1. Explicit refusal to interact with dolls.
2. Severe uncorrected hearing or visual impairment.
3. Uncontrolled severe behavioral and psychological symptoms (e.g., delusions or aggressive behavior) or a primary psychiatric disorder (e.g., schizophrenia or bipolar disorder).
4. Comorbid conditions that may impair the ability to independently perform personal hygiene activities, such as hemiplegia, paralysis, joint or skeletal disorders, or Parkinson's disease.
5. Presence of a terminal illness.
Source: ClinicalTrials.gov (NCT07907042). StuddyBuddy aggregates publicly available trial information.