UMIN-ICDS Clinical Trial

Public title

Effects of a Desktop AI Robot Intervention on Reducing Loneliness, Depression and Anxiety, and Improving Self-Esteem Among Students and Workers Engaged in Desk Work

Acronym

Evaluation of the Effects and Practicality of a Desktop AI Robot Intervention for Reducing Loneliness

Scientific Title

Evaluation of the Effects and Practicality of a Desktop AI Robot INU Intervention for Reducing Loneliness, Depression, and Anxiety and Improving Self-Esteem Among Young and Middle-Aged to Older Adults Engaged in Desk Work

Scientific Title:Acronym

Evaluation of the Effects and Practicality of a Desktop AI Robot Intervention for Reducing Loneliness

Region

Japan

Condition

Healthy students or workers aged 13-65 years who engage in desk work for at least 2 hours per da

Classification by specialty

Psychiatry

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In recent years, loneliness and social isolation among adolescents and young people, as well as middle-aged and older adults of working age, have become major social issues.
Accumulating evidence suggests that loneliness and social isolation may have a substantial impact on the development of depression and dementia.
Although the allocation of human resources is often considered as a means of addressing these issues, such approaches may be limited by regional disparities and the availability of human resources.
In this study, a desktop robot (INU) developed by Ludens AI Inc., which can be easily installed and provides interactive and monitoring functions, will be used as intervention tool.
Students and workers who engaged in desk work on a daily basis will receive intervention in which INU is installed in their work or study environment for a predetermined period.As a control intervention, a stuffed toy of the same size as INU will be installed for the same period.
The primary objectives of this preliminary study are to assess the feasibility and safety of the AI robot intervention and the feasibility of implementing the primary outcome measures, as well as to preliminarily investigate the effects of the intervention on loneliness, depression, anxiety, and low self-esteem among the target population.After completion of the intervention period, the outcomes of the AI robot intervention group and the control group will be compared to evaluate the effects and feasibility of the intervention.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

UCLA Loneliness Scale, Japanese Version (Version 3)

Key secondary outcomes

1.Patient Health Questionnaire-9 (PHQ-9) /Patient Health Questionnaire for Adolescents (PHQ-A) for participants under 18 years of age
2.Generalized Anxiety Disorder-7 (GAD-7)
3.Rosenberg Self-Esteem Scale (RSES)
4.Resilience Scale-14 (RS-14)
5.Salivary oxytocin concentration
6.Salivary cortisol concentration

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Behavior,custom

Interventions/Control_1

Intervention Group (n=15)
1.Before the intervention, participants will undergo psychological assessments of loneliness, depression, anxiety, self-esteem, and resilience using the following scales: Patient Health Questionnaire-9 (PHQ-9; PHQ-A for participants under 18 years of age), Generalized Anxiety Disorder-7 (GAD-7), Rosenberg Self-Esteem Scale (RSES), and Resilience Scale-14 (RS-14). Saliva samples will also be collected to measure and evaluate salivary oxytocin concentration as an indicator of interpersonal relationships and salivary cortisol concentration as an indicator of stress.
2.Participants will place the desktop AI robot INU on their desk at home, in a study room, or at their workplace while engaged in desk work. They will spend 2 hours per day interacting with INU and receiving monitoring and other forms of engagement from INU, from Monday through Friday, for 28 days.
3.After completion of the intervention period, participants will be reassessed using the same outcome measures and biological indicators as those administered before the intervention.

Interventions/Control_2

Control group (n=15)
1.Before the intervention, participants will undergo psychological assessments of loneliness, depression, anxiety, self-esteem, and resilience using the following scales: Patient Health Questionnaire-9 (PHQ-9; PHQ-A for participants under 18 years of age), Generalized Anxiety Disorder-7 (GAD-7), Rosenberg Self-Esteem Scale (RSES), and Resilience Scale-14 (RS-14). Saliva samples will also be collected to measure and evaluate salivary oxytocin concentration as an indicator of interpersonal relationships and salivary cortisol concentration as an indicator of stress.
2. Participants will place a stuffed toy of the same size as INU on their desk while performing desk work at home, in a study room, or at their workplace. Participants will keep the stuffed toy nearby 2 hours per day, from Monday to Friday, for 28 days.
3.After completion of the intervention period, participants will be reassessed using the same outcome measures and biological indicators as those administered before the intervention.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

13

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1.Students or workers aged 13 to 65 years.
2.Engagement in desk work for at least 2 hours per day.
3.Age of 13 to 65 years at the time of informed consent.
4.Ability to provide voluntary written and verbal informed consent to participate in the study, or to have the same willingness to participate confirmed by an appropriate legally authorized representative.

Key exclusion criteria

1.Severe visual or hearing impairment, or aphasia, making it difficult to undergo the study intervention or assessments.
2.Inability to provide appropriate informed consent due to cognitive impairment, mental illness, or other conditions.
3.Other circumstances considered inappropriate for study participation by the principal investigator or co-investigators.

Target sample size

30

Name of lead principal investigator

1st name	Manabu
Middle name
Last name	Makinodan

Organization

Kumamoto University

Division name

Department of Neuropsychiatry Faculty of Life Science Kumamoto University

Zip code

860-8556

Address

1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan

TEL

096-373-5184

Email

manabumakinodan@kumamoto-u.ac.jp

Name of contact person

1st name	Maki
Middle name
Last name	Hotta

Organization

Kumamoto University

Division name

Department of Neuropsychiatry Faculty of Life Science Kumamoto University

Zip code

860-8556

Address

1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan

TEL

096-373-5184

Homepage URL

Email

osadaei@yahoo.co.jp

Institute

Kumamoto University

Institute

Department

Personal name

Organization

Research grant from Ludens AI Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Ludens AI Inc.

Name of secondary funder(s)

Departmental Research Funds

Organization

Kumamoto University Research Ethics Committee

Address

1-1-1 Honjo, Chuo-ku, Kumamoto 860-8556, Japan

Tel

096-372-5966

Email

byi-senshin@jimu.kumamoto-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

熊本大学病院（熊本）

Date of disclosure of the study information

2026

Year

09

Month

01

Day

URL releasing protocol

https://www.kumamoto-neuropsy.jp/

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

08

Month

09

Day

Date of IRB

Anticipated trial start date

2026

Year

10

Month

01

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

08

Month

29

Day

Last modified on

2026

Year

08

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071833