Healthy adults in the community
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. People of any sex, aged 18 years or older at the time of providing informed consent 2. In possession of their own smartphone (either iOS or Android) 3. Written informed consent for participation in the trial 4. Completion of all the baseline questionnaires within one week after providing informed consent
Exclusion criteria
Exclusion criteria: 1. Cannot read or write Japanese 2. Receiving mental health treatment at the time of screening 3. Screening PHQ-9 total scores (i) of 15 or higher, or (ii) between 10 and 14, inclusive, and scoring 2 or 3 on its item 9
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in PHQ-9 from baseline to week 6 [Analysis 1] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of a major depressive episode by week 50 [Analysis 2] 2. Changes in PHQ-9 from baseline to weeks 2, 3, 4, 5; 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50 3. Changes in GAD-7 from baseline to weeks 3, 6, 26, 50 4. Changes in ISI from baseline to weeks 3, 6, 26, 50 5. Changes in WEMWBS from baseline to weeks 3, 6, 26, 50 6. Changes in CBT skills from baseline to weeks 6, 26, 50 7. Changes in WSAS, UWES, HPQ and ED-5D-5L from baseline to weeks 6, 50 8. CSQ-3, adherence to smartphone CBT, co-interventions, safety information at weeks 6 and 50 | — |
Countries
Japan
Contacts
Kyoto University Graduate School of Medicine/School of Public Health Dept of Health Promotion and Human Behavior