Adults with no to mild (subthreshold) depressive sypmtoms
Conditions
Interventions
CQ2: We will randomise those judged NOT at week 2 to the following NOT interventions or the control condition in equal proportions. 1. Motivational Interviewing-based prompts
CQ2: We will randomise
=4, we will propose BA for those who started with AT or BI and CR for those who started with BA+CR. Among those with baseline PHQ-8>
=5, we will propose the second module as if it were an alternative module to encourage a fresh start.)
CQ2: We will randomise those judged NOT at week 2 to the following NOT interventions or the contr
=5 at week 26, we will randomise and compare the following four interventions at week 26. 1. The therapy with the highest PrBest based on the POT algorithm on the Week 26 (and 28) data
when this is the same as their first-line therapy, the therapy with the second highest PrBest.
CQ3: Stratified by the PHQ-8 scores =4 or >
=5 at week 26, we will randomise and compare the following four interventions at week 26. 2. Review of the first-line therapy
CQ3: Stratified by the PHQ-8 scores =4 or >
=5 at week 26, we will randomise and compare the following four interventions at week 26. 3. User'
s choice (We will ask the participant to pick up one skill to learn, after all five skills have been explained.)
CQ3: Stratified by the PHQ-8 scores =4 or >
=5 at week 26, we will randomise and compare the following four interventions at week 26. 4. No second-line therapy
CQ5: To determine the optimal level of human involvement, we will compare the foll
Sponsors
Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: - Individuals aged 18 years or older at the time of consent. - Ownership of a personal smartphone (iPhone or Android). - Provision of informed electronic consent to participate in the study. - A PHQ-8 total score of 14 or less at screening. - Completion of the second part of the baseline questionnaire and completion of the app's introductory lesson ("Getting Started") within one week of initiating the screening survey.
Exclusion criteria
Exclusion criteria: Exclusion criteria: - Inability to read or understand Japanese. - Current treatment for a mental health condition at the time of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes differ depending on the clinical question addressed within the platform trial. In most cases, they involve depressive symptom severity measured by the Patient Health Questionnaire-8 (PHQ-8). Specific metrics include: CQ1 (First-line interventions): Change in PHQ-8 scores from baseline (Week 0) to Week 26. CQ2 (NOT interventions): Change in PHQ-8 scores from Week 2 to Week 26 CQ3 (Second-line interventions): Change from Week 26 to Week 52 CQ4 (SPOT algorithm): Total Burden of Depression (TBD), which is calculated as the integral of PHQ-8 scores over 52 weeks. CQ5 (Encouragement LINE): Change in PHQ-8 scores from baseline (Week 0) to Week 26. CQ6 (Incentives): Proportion of randomised participants out of those approached. CQ7 (POT algorithm for subgroups): Change in PHQ-8 scores from baseline (Week 0) to Week 26. CQ8 (New BI module): Change in PHQ-8 scores from baseline (Week 0) to Week 26 or from Week 26 to Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes We will analyse the following secondary outcomes to supplement and expand the interpretation of the primary outcomes. The statistical analysis plan for each CQ will detail how to analyse these outcomes. Changes in PHQ-8 from baseline to Weeks 2, 3, 4, 5, 6, 10, 14, 18, 22, 26, 27, 28, 29, 30, 31, 32, 36, 40, 44, 48, 52 Changes in Insomnia Severity Index (ISI) from baseline to Weeks 3, 6, 26, 29, 32, and 52. Changes in Short Warwick-Edinburgh Mental Well-being Scale (SWEMWBS) from baseline to Weeks 3, 6, 26, 29, 32, and 52. Tertiary Outcomes We will conduct exploratory analyses of the following outcomes in order to describe the changes in the BEATRICE platform in a multifaceted way. Onset of a major depressive episode as diagnosed with the CIDI. Changes in social function, work engagement, presenteeism, health utility and medical expenditures from baseline to Weeks 6, 26, 32, 52. Change in cognitive-behavioural skills from baseline to Weeks 26, and 52. Changes in premenstrual mental symptoms (PMS-8) from baseline to Weeks 26 and 52. Satisfaction with the intervention (Customer Satisfaction Questionnare-3, CSQ-3), app usage, concomitant treatments, and adverse events | — |
Countries
Japan
Contacts
Public ContactToshiaki Furukawa
Kyoto University Office of Institutional Advancement and Communications
Outcome results
None listed