LonelinessNCT05054660
Applying a Chatbot to Geriatric Patients in Psychiatric Clinics: A Pilot Study
A study testing caring chatbot in people with Loneliness and Geriatric Depression, run by Chang Gung Memorial Hospital.
Trial summary
This study will use the caring chatbot developed by the Taipei University of Technology team to provide care for participants and use robots to talk to them to collect daily changes in mood, sleep, and activities, and analyze the factors that affect the physical and mental health of the elderly. Read more about this study
- Who is it for?
- Ages 55 to 110 years
- Conditions the study is for
- Loneliness, Geriatric Depression
- What is being tested?
- caring chatbot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 27 Sep 2021to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- with the diagnosis of persistent depressive disorder, major depressive disorder, general anxiety disorder, panic disorder, or agoraphobia
- the condition of their disease is relatively stable (defined as no thought of death and no medication adjustment in the recent 3 months).
- Have a personal mobile phone or communicator that can connect to the Internet
Who cannot join
- Those who are unwilling to participate in this research
- Those who have poor assessment ability by clinicians and cannot understand the content of the questionnaire; or those who cannot continue to complete the test due to their physical condition
- Comorbid schizophrenia or bipolar disorder
- Patients with dementia, brain injury, substance abuse, and stroke
Trial locations and contacts
No sites are listed yet.
About this study
This study will use the caring chatbot developed by the Taipei University of Technology team to provide care for participants and use robots to talk to them to collect daily changes in mood, sleep, and activities, and analyze the factors that affect the physical and mental health of the elderly.
Read the detailed description
The prevalence of anxiety and depression in middle-aged and elderly people is quite high. Among the risk factors for illness, "loneliness" is closely related to the physical and mental health of the elderly: the higher the loneliness of the elderly, the more likely to develop unhealthy lifestyle habits and emotional symptoms such as depression and anxiety. Depression and anxiety are often comorbid, and the diagnoses of the two groups have many symptoms that overlap each other. Emotional symptoms that have not been effectively treated have a great impact on the quality of life, and the drug treatment of emotional disorders in the elderly is more difficult. In addition to medication, maintaining a healthy lifestyle is also conducive to the control of emotional disorders.
Information technology has been used in supplementary medical care and maintenance of physical and mental health for decades. However, reviewing the literature, there is less research on applications developed in cooperation between the information field and the field of psychiatric medical care, and there are no applications developed for the mental health of middle-aged and elderly people.
This study will use the caring chatbot developed by the National Taipei University of Technology team to provide care for the participants enrolled from the psychiatric outpatient department, and use the chatbot to talk to them to collect daily changes in mood, sleep, and activities, and analyze the factors that affect the mental health of the elderly.
This research anticipates the following goals:
- With the chatbot developed, it provides care for subjects every day and collects their daily changes in mood, sleep, and activities.
- Analyze the relationship between robot interaction and emotional changes, and evaluate the impact of chatbot intervention on the health behavior of the case.
- Conditions
- Loneliness, Geriatric Depression
- Being tested
- caring chatbot
- Keywords
- geriatric psychiatry, chatbot, conversational agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caring chatbotOther
The investigators will use the developed caring chatbot to provide care to the cases and to collect case treatment data and interaction data between the case and the caring chatbot.
| Study group | Role | What they receive |
|---|---|---|
| caring chatbot | Experimental | The investigators will enroll participants aged over 55 in the psychiatric outpatient department. The participants will get a one-month caring chatbot and can interact with the chatbot freely. Receives: Other: caring chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptance measured by seven-point Likert scales
Satisfacation (How satisfied were you with Chatbot?), usability (How easy was talking to Chatbot?), continue (How much would you like to continue working with Chatbot?) and adherence (How likely is it that you will follow Chatbot's advice?) were measured by single items on seven-point Likert scales (with 1= "not at all" and 7="very much").
Measured: at the end of one-month-intervention of the caring chatbot
Secondary outcomes (5)
Change from baseline "loneliness" measured by UCLA Loneliness Scale
The UCLA Loneliness Scale (version 3) is a 20-item measure that assesses how often a person feels disconnected from others. Using a 4-point rating scale (1= never; 4 = always), participants answer 20 questions, and researchers later reverse-code the positively worded items so that high values mean more loneliness.
Measured: before and at the end of one-month-intervention of the caring chatbot
Change from baseline "depression" measured by Geriatric Depression Scale-Short Form (GDS-15)
Geriatric Depression Scale (GDS) is designed for the older population. A Short Form GDS consisting of 15 questions. Of the 15 items, 10 indicated the presence of depression when answered positively, while the rest indicated depression when answered negatively. Scores of 5-8 indicate mild depression; 9-11 indicate moderate depression; 12-15 indicate severe depression.
Measured: before and at the end of one-month-intervention of the caring chatbot
Change from baseline "anxiety" measured by Hospital Anxiety and Depression Scale- Anxiety subscale
Hospital Anxiety and Depression Scale (HADS) is developed for people with physical illnesses. This scale includes a total of 14 questions. There are 7 questions about anxiety and depression, each with a 4-point scoring method (0-3 points). The higher the total score, the greater the anxiety or the greater the depression. Due to the high overlap between the topics of the depression subscale and the GDS, this study only uses the anxiety subscale.
Measured: before and at the end of one-month-intervention of the caring chatbot
Change from baseline "quality of life" measured by Short Form Quality Life Sale (SF-12)
Short Form Quality Life Sale (SF-12) is the most commonly used questionnaire in the study of the quality of life of the elderly, with a total score ranging from 13~43. A higher score reflects a better life quality.
Measured: before and at the end of one-month-intervention of the caring chatbot
Change from baseline "physical activity" measured by International Physical Activity Questionnaire Self-Administered Short Version (IPAQ-SS)
International Physical Activity Questionnaire Self-Administered Short Version (IPAQ-SS) measures the physical activity of the participant in the past seven days by self-filled method. The questionnaire is consisted of four domains: (1)during transportation, (2) at work, (3) during household and gardening tasks and (4) during leisure time, including exercise and sport participation. In each of the four domains the number of days per week and time per day spent in both moderate and vigorous activity are recorded.
Measured: before and at the end of one-month-intervention of the caring chatbot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start27 Sep 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- psychiatry outpatient using the investigator-developed-chatbot, and evaluate effectiveness, acceptability, usability, and adoption
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taipei University of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054660
- Sponsor's protocol ID
- 202001915B0C601
- Status last verified
- Aug 2021
- First submitted
- 1 Sep 2021
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying a Chatbot to Geriatric Patients in Psychiatric Clinics: A Pilot Study
- ClinicalTrials.gov ID
- NCT05054660
- Acronym / sponsor ID
- 202001915B0C601
- Conditions
- Loneliness, Geriatric Depression
- Keywords
- geriatric psychiatry, chatbot, conversational agent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Taipei University of Technology
- Study start
- 27 Sep 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 23 Sep 2021 (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.
This study will use the caring chatbot developed by the Taipei University of Technology team to provide care for participants and use robots to talk to them to collect daily changes in mood, sleep, and activities, and analyze the factors that affect the physical and mental health of the elderly.
Detailed description
The prevalence of anxiety and depression in middle-aged and elderly people is quite high. Among the risk factors for illness, "loneliness" is closely related to the physical and mental health of the elderly: the higher the loneliness of the elderly, the more likely to develop unhealthy lifestyle habits and emotional symptoms such as depression and anxiety. Depression and anxiety are often comorbid, and the diagnoses of the two groups have many symptoms that overlap each other. Emotional symptoms that have not been effectively treated have a great impact on the quality of life, and the drug treatment of emotional disorders in the elderly is more difficult. In addition to medication, maintaining a healthy lifestyle is also conducive to the control of emotional disorders.
Information technology has been used in supplementary medical care and maintenance of physical and mental health for decades. However, reviewing the literature, there is less research on applications developed in cooperation between the information field and the field of psychiatric medical care, and there are no applications developed for the mental health of middle-aged and elderly people.
This study will use the caring chatbot developed by the National Taipei University of Technology team to provide care for the participants enrolled from the psychiatric outpatient department, and use the chatbot to talk to them to collect daily changes in mood, sleep, and activities, and analyze the factors that affect the mental health of the elderly.
This research anticipates the following goals:
- With the chatbot developed, it provides care for subjects every day and collects their daily changes in mood, sleep, and activities.
- Analyze the relationship between robot interaction and emotional changes, and evaluate the impact of chatbot intervention on the health behavior of the case.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- psychiatry outpatient using the investigator-developed-chatbot, and evaluate effectiveness, acceptability, usability, and adoption
| Arm | Type | Receives |
|---|---|---|
| caring chatbot | Experimental | Other: caring chatbotThe investigators will enroll participants aged over 55 in the psychiatric outpatient department. The participants will get a one-month caring chatbot and can interact with the chatbot freely. |
Who may qualify
- Ages
- 55 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- with the diagnosis of persistent depressive disorder, major depressive disorder, general anxiety disorder, panic disorder, or agoraphobia
- the condition of their disease is relatively stable (defined as no thought of death and no medication adjustment in the recent 3 months).
- Have a personal mobile phone or communicator that can connect to the Internet
Key exclusion criteria (4 listed)
- Those who are unwilling to participate in this research
- Those who have poor assessment ability by clinicians and cannot understand the content of the questionnaire; or those who cannot continue to complete the test due to their physical condition
- Comorbid schizophrenia or bipolar disorder
- Patients with dementia, brain injury, substance abuse, and stroke
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 |
|---|---|---|
| caring chatbotThe investigators will use the developed caring chatbot to provide care to the cases and to collect case treatment data and interaction data between the case and the caring chatbot. | Other | caring chatbot |
Primary outcome
acceptance measured by seven-point Likert scales
Time frame: at the end of one-month-intervention of the caring chatbot
Satisfacation (How satisfied were you with Chatbot?), usability (How easy was talking to Chatbot?), continue (How much would you like to continue working with Chatbot?) and adherence (How likely is it that you will follow Chatbot's advice?) were measured by single items on seven-point Likert scales (with 1= "not at all" and 7="very much").
5 secondary outcomes
Change from baseline "loneliness" measured by UCLA Loneliness Scale
Time frame: before and at the end of one-month-intervention of the caring chatbot
Change from baseline "depression" measured by Geriatric Depression Scale-Short Form (GDS-15)
Time frame: before and at the end of one-month-intervention of the caring chatbot
Change from baseline "anxiety" measured by Hospital Anxiety and Depression Scale- Anxiety subscale
Time frame: before and at the end of one-month-intervention of the caring chatbot
Change from baseline "quality of life" measured by Short Form Quality Life Sale (SF-12)
Time frame: before and at the end of one-month-intervention of the caring chatbot
Change from baseline "physical activity" measured by International Physical Activity Questionnaire Self-Administered Short Version (IPAQ-SS)
Time frame: before and at the end of one-month-intervention of the caring chatbot
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing caring chatbot in people with Loneliness and Geriatric Depression, run by Chang Gung Memorial Hospital.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Hsin Chou, MD ((03)3281288 ext. 2485, b9302015@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acceptance measured by seven-point Likert scales (time frame: at the end of one-month-intervention of the caring chatbot). 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 23 Sep 2021.