TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBlueSkeye AI
About this trial
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
Qualifiers
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
Disqualifiers
● 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.
Trial design
Treatments tested in this trial
- TrueBlue App
Treatment groups
125 Participants
are divided into 1 treatment groupSponsors and collaborators
BlueSkeye AI
Lead sponsor
Institute of Mental Health Nottingham
Collaborator
Nottinghamshire Healthcare NHS Trust
Collaborator
Nottingham University Hospitals NHS Trust
Collaborator
Source ClinicalTrials.gov