Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058696) titled 'BEATRICE (Best, Efficient and Affordable Training in Resilience In Constant Evolution) Platform Trial' on Nov. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Kyoto University
Condition:
Condition - Adults with no to mild (subthreshold) depressive sypmtoms
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The overarching aim of this platform trial is to minimize the cumulative burden of depressive symptoms, measured as the sum of weekly to monthly PHQ-8 scores over 12 months, through a series of randomised investigations targeting the following clinical questions (CQ).
CQ1. External validity of the personalised & optimised therapy (POT) algorithm for first-line interventions, developed from the RESiLIENT trial data (Furukawa et al, submitted)
CQ2. Strategies to help individuals not on track (NOT) during initial weeks of intervention,
CQ3. Second-line interventions at 6 months,
CQ4. Development of the super-personalised & optimised therapy (SPOT) algorithm based on longitudinal data,
CQ5. Encouragement messages via LINE (a widely used instant messaging app in Japan, similar to WhatsApp) to improve adherence to the app
CQ6. Financial incentives to promote the uptake of the app in the population
CQ7. Refinement of the POT algorithm for specific populations (e.g., new employees, factory workers, highly skilled brain workers, healthcare workers),
CQ8. Added value of cognitive restructuring for BI.
The BEATRICE platform is a living RCT capable of addressing new clinical questions and accommodating future refinements by leveraging rapid and as-yet-unforeseen technological advances, such as the use of generative AI to guide users through cognitive restructuring and problem-solving worksheets.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - 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
Interventions/Control_2 - CQ2: We will randomise those judged NOT at week 2 to the following NOT interventions or the control condition in equal proportions.
2. Proposal to take a break
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key 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.
Key exclusion criteria - Exclusion criteria:
- Inability to read or understand Japanese.
- Current treatment for a mental health condition at the time of screening.
Target Size - 42000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 05 Day
Anticipated trial start date - 2025 Year 11 Month 01 Day
Last follow-up date - 2029 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067053
Disclaimer: Curated by HT Syndication.
