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 group

Locations

2
Nottingham University Hospitals NHS TrustNG7 2UH, NottinghamNottinghamshire, United Kingdom
Nottinghamshire Healthcare NHS Foundation TrustNG3 6AA, Nottingham United Kingdom

Sponsors and collaborators

BlueSkeye AI

Lead sponsor

Institute of Mental Health Nottingham

Collaborator

Nottinghamshire Healthcare NHS Trust

Collaborator

Nottingham University Hospitals NHS Trust

Collaborator