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TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
Sponsor: BlueSkeye AI
Summary
This trial will assess the safety, feasibility, acceptability, usability and agreement with validated scales of an automated mood monitoring App (TrueBlue), in adult, perinatal participants (recruited between 12 weeks of pregnancy and 12 weeks post-partum), recruited across multiple sites in Nottinghamshire, United Kingdom (UK). An initial within-study pilot phase will assess key aspects of the study including recruitment rate, usability issues and a detailed understanding of any device related adverse events; prior to full recruitment of a total 125 participants over a total 14-month period.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
125
Start Date
2024-10-01
Completion Date
2026-12-30
Last Updated
2025-09-19
Healthy Volunteers
Yes
Interventions
TrueBlue App
The use of the TrueBlue App, to generate automated measures of mood that can be assessed for agreement with validated clinical scales eg. PHQ9.
Locations (2)
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, United Kingdom