General employees of participating companies, regardless of whether they have any specific disease. occupational mental health, work productivity, presenteeism, well-being, depression, anxiety, insomnia, digital mental health, cognitive behavioral therapy
Conditions
Interventions
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 digit
Cognitive Behavioral Therapy
KOKOROBO, AI CBT, digital mental health, Psychological First Aid, online counseling, sleep diary, communication training, workplace intervention
Sponsors
Kuga Hironori
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactAkira Iino
National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry
Outcome results
None listed