Actively Recruiting
TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
Led by BlueSkeye AI · Updated on 2025-09-19
125
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
Sponsors
B
BlueSkeye AI
Lead Sponsor
I
Institute of Mental Health Nottingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 smartphone device (may be provided by the study for up to 10 participants without a personal device)
- Has a current GP within Nottinghamshire
You will not qualify if you...
- Current clinically diagnosed psychiatric disorder other than depression
- Previous history of a clinically diagnosed psychiatric disorder other than depression and generalized anxiety disorder (including Psychosis, Bipolar Disorder, Personality Disorder, Substance Abuse Disorders, Eating Disorders)
- Clinical diagnosis of Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder, Parkinson's Disease, or other current neurological disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Not Yet Recruiting
2
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, United Kingdom, NG3 6AA
Actively Recruiting
Research Team
J
John Michaelis, BSc
CONTACT
N
Neil Nixon, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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