TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
Recruiting · NCT06364488 · Interventional (participants receive a specific treatment) · Lead sponsor: BlueSkeye AI
View the official record on ClinicalTrials.gov →Interventions studied
TrueBlue App
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed.
- Nottinghamshire Healthcare NHS Foundation Trust - Nottingham, United Kingdom
- Nottingham University Hospitals NHS Trust - Nottingham, Nottinghamshire, United Kingdom