NCT06364488 TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
| NCT ID | NCT06364488 |
| Status | Recruiting |
| Phase | — |
| Sponsor | BlueSkeye AI |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 125 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 125 participants in total. It began in 2024-10-01 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Neil Nixon, MBBS
PRINCIPAL INVESTIGATOR
School of Medicine, University of Nottingham and Nottinghamshire Healthcare NHS Trust
Frequently Asked Questions
Who can join the NCT06364488 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06364488 currently recruiting?
Yes, NCT06364488 is actively recruiting participants. Contact the research team at john@blueskeye.com for enrollment information.
Where is the NCT06364488 trial being conducted?
This trial is being conducted at Nottingham, United Kingdom, Nottingham, United Kingdom.
Who is sponsoring the NCT06364488 clinical trial?
NCT06364488 is sponsored by BlueSkeye AI. The principal investigator is Neil Nixon, MBBS at School of Medicine, University of Nottingham and Nottinghamshire Healthcare NHS Trust. The trial plans to enroll 125 participants.
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