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Clinical Trials in the UK / NCT06364488
Recruiting Not applicable

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

NCT06364488 · tracked via the Priya Life Science UK tracker
Sponsor
BlueSkeye AI
Phase
Not applicable
Started
2024-10-01
Last updated
2025-09-19

Condition(s) studied

DepressionDepression, PostpartumAnxiety in PregnancyAnxietyAnhedoniaPerinatal Depression

Investigational drug(s) / intervention(s)

TrueBlue App

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: \- 18 years or older * Fluent in spoken and written English * Has capacity to provide consent * At least 12 weeks pregnant or less than 12 weeks postpartum * Access to internet connectivity * Access to a compatible smart phone device (for up to 10 participants, where needed through not having a personal device, this access may be provided through the study team). * Has a current GP within Nottinghamshire Exclusion Criteria: * ● Current clinically diagnosed psychiatric disorder other than depression * Previous history of a clinically diagnosed psychiatric disorder, other than depression and generalised anxiety disorder (including previous Psychosis, Bipolar Disorder, Personality Disorder, Substance Abuse Disorders, Eating Disorders) * Clinical diagnosis of an Autistic Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Parkinson's Disease or other current Neurological Disorder.

Primary outcome measure(s)

  • The rate of device related adverse events — up to12 weeks
    Percentage of participants who experience at least one device related adverse event during the 12-week period from baseline to end of app use (ascertained through both voluntary reporting and active surveillance at 6 and 12 weeks).

Trial sites (2)

FacilityCityRegionStatus
Nottingham University Hospitals NHS Trust Nottingham Nottinghamshire Not Yet Recruiting
Nottinghamshire Healthcare NHS Foundation Trust Nottingham United Kingdom Recruiting

Other trials for the same condition

ELE-101 Safety & Tolerability Study in Healthy Participants and Patients With Depression Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06364488 on ClinicalTrials.gov ↗ ← All trials in the UK