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A study of KOKOROBO, an AI-based digital mental health support system, for workplace mental health

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	General employees of participating companies, regardless of whether they have any specific disease.
Date of first enrollment	01/06/2026
Target sample size	1000
Countries of recruitment
Study type	Interventional
Intervention(s)	Departments or units within participating companies will be randomized in a 1:1 ratio to either the intervention group or the control group. In the intervention group, participants will use the digital mental health support system "KOKOROBO." Based on self-report assessment results at baseline, participants will be classified into three severity levels: below mild, mild, and moderate or higher. Tailored support will be provided according to the severity classification. Participants classified as below mild will receive feedback on their results and general health and lifestyle information. Participants classified as mild will receive feedback and will be encouraged to use AI-based cognitive behavioral therapy, such as "Kokoro Conditioner plus," or a sleep diary application. Participants classified as moderate or higher will receive feedback and, if they wish, will be offered rapid Psychological First Aid via an online system up to three times. When necessary, they will also be encouraged to consult occupational health staff within their company or seek medical care. In addition, the intervention group will receive a communication training program using AI-generated scenarios, aiming to promote workplace communication and mental health awareness. The control group will continue usual workplace health measures without receiving KOKOROBO-based individualized support or the communication training program during Phase 1. However, for safety reasons, emergency guidance and consultation resources will be provided to both groups when serious risk is suggested.

Outcome(s)

Primary Outcome

The primary outcome is work productivity, specifically presenteeism, assessed using the Japanese short version of the World Health Organization Health and Work Performance Questionnaire (WHO-HPQ). Self-reported work performance will be evaluated. The primary analysis will compare presenteeism scores between the intervention and control groups at 12 weeks, adjusted for baseline values. Assessments will be conducted at baseline (W0), 12 weeks (W12), and 24 weeks (W24).

Secondary Outcome

Secondary outcomes are as follows: 1. Absenteeism Absenteeism will be assessed using the WHO-HPQ at W0, W12, and W24. 2. Depressive symptoms Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9) at W0, W4, W8, W12, W16, W20, and W24. 3. Anxiety symptoms Anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) at W0, W4, W8, W12, W16, W20, and W24. 4. Insomnia symptoms Insomnia symptoms will be assessed using the Insomnia Severity Index (ISI) at W0, W4, W8, W12, W16, W20, and W24. 5. Work engagement Work engagement will be assessed using the Japanese short version of the Utrecht Work Engagement Scale (UWES-9) at W0, W12, and W24. 6. Subjective well-being Subjective well-being will be assessed using the WHO-5 Well-Being Index at W0, W12, and W24. 7. Quality of life Quality of life will be assessed using ICECAP-A at W0, W12, and W24. 8. Economic evaluation Productivity loss will be estimated using WHO-HPQ data. Exploratory cost-effectiveness analyses will be conducted using ICECAP-A and self-reported healthcare cost information. 9. Implementation and behavioral indicators KOKOROBO usage continuation rate, usage frequency, time to discontinuation, consultation with occupational health staff or external medical institutions, and use of the communication training program will be evaluated exploratorily. 10. Feasibility indicators in the Extension phase In the Extension phase after W24, transition rate, continuation rate, usage status, response completion rate, usability, acceptability, satisfaction, safety monitoring status, and operational issues will be descriptively evaluated among participants who wish to continue.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1. Individuals aged 18 years or older at the time of informed consent. 2. Individuals who belong to the participating department or unit and are expected to continue working during the 24-week intervention and observation period. 3. Individuals who have no scheduled transfer or long-term leave exceeding four consecutive weeks before the primary endpoint at 12 weeks. 4. Individuals who are able to provide electronic informed consent and complete the baseline assessment before the start of the intervention. 5. Individuals who are able to receive emails and access the internet using electronic devices such as smartphones or personal computers. 6. Individuals who are able to answer the questionnaires in Japanese.
Exclude criteria	1. Individuals currently receiving treatment for mental health problems who have been explicitly instructed by their attending physician to avoid concurrent treatment or consultation. 2. Individuals who are clearly unable to reach the primary endpoint due to long-term leave, scheduled resignation, scheduled long-term absence, or similar circumstances during the intervention period. 3. Individuals judged by the principal investigator to be inappropriate for participation in the study.