DementiaNCT07907042
Effects of Doll Therapy on Apathy and Activities of Daily Living Initiation Deficits in Older Adults With Dementia
A study testing Doll Therapy in people with Dementia, run by Xinyu ZHANG at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Doll Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2026to 14 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 years or older.
- 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).
- Hospitalization duration exceeding 4 weeks.
- Apathy Evaluation Scale-Informant Version (AES-I) score ≥33.
- Not participating in any other clinical research trials.
- Voluntary participation with written informed consent provided by the participant or their legally authorized representative.
Who cannot join
- Explicit refusal to interact with dolls.
- Severe uncorrected hearing or visual impairment.
- Uncontrolled severe behavioral and psychological symptoms (e.g., delusions or aggressive behavior) or a primary psychiatric disorder (e.g., schizophrenia or bipolar disorder).
- 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.
- Presence of a terminal illness.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Geriatric Hospital
Guangdong, Guangzhou, 510000
Guangzhou Geriatric Hospital, +862087412484
About this study
Official title: Effects of Doll Therapy on Apathy and Activities of Daily Living Initiation Deficits in Older Adults With Dementia: a Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
Background
Dementia is a progressive condition characterized by cognitive impairment, neuropsychiatric symptoms, and declining functional independence. Impairment in basic activities of daily living (BADL), particularly dressing and personal hygiene, represents a major challenge in dementia care. Such impairment may result not only from cognitive and physical limitations but also from apathy-related difficulties in initiating goal-directed activities.
Apathy is characterized by diminished motivation, reduced initiative, and decreased engagement in purposeful activities. It is commonly observed in patients with dementia and may contribute to increasing dependence on caregivers. Interventions targeting apathy may therefore have potential benefits for maintaining daily functioning and reducing care dependency.
Doll therapy is an emerging non-pharmacological intervention that provides sensory stimulation, emotional engagement, and opportunities for social interaction. Existing evidence suggests potential benefits for behavioral and psychological symptoms of dementia. Nevertheless, evidence regarding its effects on apathy and BADL initiation deficits remains limited.
Study Objectives
The primary objective of this study is to evaluate the effectiveness of doll therapy in reducing apathy among older adults with dementia. The secondary objective is to investigate whether doll therapy improves basic activities of daily living, particularly difficulties in initiating daily activities, as well as quality of life and neuropsychiatric symptoms.
Study Design and Procedures
This study is a randomized controlled trial with an assessor-blinded, parallel-group design. Eligible participants will be randomly allocated to either the intervention group or the control group using stratified permuted block randomization.
Participants in the intervention group will receive doll therapy in addition to usual care. The intervention will be delivered three times per week, with each session lasting approximately 30 minutes, over a 2-week period. The control group will receive usual care without doll therapy.
Outcome assessments will be conducted at three time points: baseline, Week 2 (immediately after the intervention), and Week 4 (2 weeks after completion of the intervention). Outcome assessors will remain unaware of participants' group assignments.
Expected Contribution
This study aims to provide evidence regarding the potential effectiveness of doll therapy in reducing apathy and improving daily functioning among older adults with dementia. The findings may inform the development of practical, low-cost, non-pharmacological interventions for dementia care.
- Conditions
- Dementia
- Being tested
- Doll Therapy
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doll TherapyBehavioural
Doll therapy is a non-pharmacological behavioral intervention involving guided interaction with therapeutic dolls. Trained personnel will facilitate interactions to promote emotional engagement, motivation, and participation in daily activities. The intervention will be delivered three times per week, with each session lasting approximately 30 minutes, over a 2-week period, in addition to usual care.
| Study group | Role | What they receive |
|---|---|---|
| Doll Therapy Group | Experimental | Participants in the experimental group will receive doll therapy in addition to usual care. Doll therapy will be administered three times per week, with each session lasting approximately 30 minutes, over a 2-week period. The intervention will involve guided interaction with therapeutic dolls to promote emotional engagement, motivation, and participation in activities of daily living. Receives: Behavioral: Doll Therapy |
| Usual Care Group | No intervention | Participants in the control group will receive usual care according to standard hospital nursing practices. Usual care includes routine medical treatment, nursing care, and assistance with basic activities of daily living as needed. No additional structured intervention or doll therapy will be administered as part of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apathy Evaluation Scale-Informant Version (AES-I) Total Score
Apathy will be assessed using the Apathy Evaluation Scale-Informant Version (AES-I), an 18-item informant-rated scale designed to evaluate apathy in patients with dementia. Each item is rated on a 4-point Likert scale, yielding a total score ranging from 18 to 72. Higher scores indicate greater severity of apathy.
Measured: At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
Basic Activities of Daily Living Assessment for Patients with Cognitive Impairment (C-BADL) Score
Basic activities of daily living (BADL) will be assessed using the Cognitive Impairment-Basic Activities of Daily Living (C-BADL) assessment. Functional limitations are classified into eight phenotypes: independence (no deficits), initiation deficits (inability to independently initiate a task or recognize the need to perform it), planning deficits (failure to prepare necessary items before performing a task), organizational deficits (difficulty sequencing actions logically or monitoring task performance), partial execution deficits (requiring minimal physical assistance), severe execution deficits (requiring moderate physical assistance), complete inability (requiring full assistance), and resistance to care
Measured: At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
Secondary outcomes (2)
Quality of Life in Alzheimer's Disease (QOL-AD) Score
Quality of life will be assessed using the Quality of Life in Alzheimer's Disease (QOL-AD) scale. The scale consists of 13 items covering physical health, energy, mood, living situation, memory, family relationships, marital relationship, friendships, overall self-perception, ability to perform household activities, ability to enjoy leisure activities, financial situation, and overall quality of life. Each item is rated on a 4-point scale. Higher scores indicate better quality of life.
Measured: At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
Neuropsychiatric Inventory Questionnaire (NPI-Q) Total Severity Score
The Neuropsychiatric Inventory Questionnaire (NPI-Q) assesses 12 neuropsychiatric symptoms in patients with dementia. Each symptom is evaluated based on its presence or absence and, if present, its severity. Higher scores indicate greater severity of neuropsychiatric symptoms.
Measured: At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start10 Aug 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion14 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinyu ZHANG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xinyu ZHANG, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907042
- Sponsor's protocol ID
- 20260801
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Doll Therapy on Apathy and Activities of Daily Living Initiation Deficits in Older Adults With Dementia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07907042
- Acronym / sponsor ID
- 20260801
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Xinyu ZHANGUniversity, hospital or other
- Study start
- 10 Aug 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 30 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background
Dementia is a progressive condition characterized by cognitive impairment, neuropsychiatric symptoms, and declining functional independence. Impairment in basic activities of daily living (BADL), particularly dressing and personal hygiene, represents a major challenge in dementia care. Such impairment may result not only from cognitive and physical limitations but also from apathy-related difficulties in initiating goal-directed activities.
Apathy is characterized by diminished motivation, reduced initiative, and decreased engagement in purposeful activities. It is commonly observed in patients with dementia and may contribute to increasing dependence on caregivers. Interventions targeting apathy may therefore have potential benefits for maintaining daily functioning and reducing care dependency.
Doll therapy is an emerging non-pharmacological intervention that provides sensory stimulation, emotional engagement, and opportunities for social interaction. Existing evidence suggests potential benefits for behavioral and psychological symptoms of dementia. Nevertheless, evidence regarding its effects on apathy and BADL initiation deficits remains limited.
Study Objectives
The primary objective of this study is to evaluate the effectiveness of doll therapy in reducing apathy among older adults with dementia. The secondary objective is to investigate whether doll therapy improves basic activities of daily living, particularly difficulties in initiating daily activities, as well as quality of life and neuropsychiatric symptoms.
Study Design and Procedures
This study is a randomized controlled trial with an assessor-blinded, parallel-group design. Eligible participants will be randomly allocated to either the intervention group or the control group using stratified permuted block randomization.
Participants in the intervention group will receive doll therapy in addition to usual care. The intervention will be delivered three times per week, with each session lasting approximately 30 minutes, over a 2-week period. The control group will receive usual care without doll therapy.
Outcome assessments will be conducted at three time points: baseline, Week 2 (immediately after the intervention), and Week 4 (2 weeks after completion of the intervention). Outcome assessors will remain unaware of participants' group assignments.
Expected Contribution
This study aims to provide evidence regarding the potential effectiveness of doll therapy in reducing apathy and improving daily functioning among older adults with dementia. The findings may inform the development of practical, low-cost, non-pharmacological interventions for dementia care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doll Therapy Group | Experimental | Behavioral: Doll TherapyParticipants in the experimental group will receive doll therapy in addition to usual care. Doll therapy will be administered three times per week, with each session lasting approximately 30 minutes, over a 2-week period. The intervention will involve guided interaction with therapeutic dolls to promote emotional engagement, motivation, and participation in activities of daily living. |
| Usual Care Group | No intervention | –Participants in the control group will receive usual care according to standard hospital nursing practices. Usual care includes routine medical treatment, nursing care, and assistance with basic activities of daily living as needed. No additional structured intervention or doll therapy will be administered as part of the study. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 60 years or older.
- 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).
- Hospitalization duration exceeding 4 weeks.
- Apathy Evaluation Scale-Informant Version (AES-I) score ≥33.
- Not participating in any other clinical research trials.
Key exclusion criteria (5 listed)
- Explicit refusal to interact with dolls.
- Severe uncorrected hearing or visual impairment.
- Uncontrolled severe behavioral and psychological symptoms (e.g., delusions or aggressive behavior) or a primary psychiatric disorder (e.g., schizophrenia or bipolar disorder).
- 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.
- Presence of a terminal illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doll TherapyDoll therapy is a non-pharmacological behavioral intervention involving guided interaction with therapeutic dolls. Trained personnel will facilitate interactions to promote emotional engagement, motivation, and participation in daily activities. The intervention will be delivered three times per week, with each session lasting approximately 30 minutes, over a 2-week period, in addition to usual care. | Behavioural | Doll Therapy Group |
Primary outcome
Apathy Evaluation Scale-Informant Version (AES-I) Total Score
Time frame: At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
Apathy will be assessed using the Apathy Evaluation Scale-Informant Version (AES-I), an 18-item informant-rated scale designed to evaluate apathy in patients with dementia. Each item is rated on a 4-point Likert scale, yielding a total score ranging from 18 to 72. Higher scores indicate greater severity of apathy.
Basic Activities of Daily Living Assessment for Patients with Cognitive Impairment (C-BADL) Score
Time frame: At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
Basic activities of daily living (BADL) will be assessed using the Cognitive Impairment-Basic Activities of Daily Living (C-BADL) assessment. Functional limitations are classified into eight phenotypes: independence (no deficits), initiation deficits (inability to independently initiate a task or recognize the need to perform it), planning deficits (failure to prepare necessary items before performing a task), organizational deficits (difficulty sequencing actions logically or monitoring task performance), partial execution deficits (requiring minimal physical assistance), severe execution deficits (requiring moderate physical assistance), complete inability (requiring full assistance), and resistance to care
2 secondary outcomes
Quality of Life in Alzheimer's Disease (QOL-AD) Score
Time frame: At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
Neuropsychiatric Inventory Questionnaire (NPI-Q) Total Severity Score
Time frame: At baseline, Week 2 (end of intervention), and Week 4 (follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doll Therapy in people with Dementia, run by Xinyu ZHANG at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyu Zhang (86+136-5229-6193, zxy0206cc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apathy Evaluation Scale-Informant Version (AES-I) Total Score (time frame: At baseline, Week 2 (end of intervention), and Week 4 (follow-up).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.