TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety

StatusRecruiting

PhaseNot applicable

Started2024-10-01

Record status

This record was last updated September 19, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

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.

Amendment record

Amended 2 times since 2024-04-09; most recent filed 2025-09-16. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-29.

2025-09-16

Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2

2024-08-05

Amendment Study Status v1

2024-04-09

Original filing

Trial Details

NCT Number	NCT06364488
Lead Sponsor	BlueSkeye AI Collaborators: Institute of Mental Health Nottingham, Nottinghamshire Healthcare NHS Trust, Nottingham University Hospitals NHS Trust
Conditions	Depression, Depression, Postpartum, Anxiety in Pregnancy, Anxiety, Anhedonia, Perinatal Depression
Enrollment	125 participants
Start Date	2024-10-01
Primary Completion	2026-07-31 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-09-19