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TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety

Launched by BLUESKEYE AI · Apr 9, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Depression Anxiety Perinatal

ClinConnect Summary

The TrueBlue Clinical Study is researching a mobile phone app called TrueBlue, designed to help monitor mood and emotions in women who are either pregnant or have recently given birth. The main goal of this study is to see how safe and easy it is to use this app, and whether it accurately reflects the mood levels of the users. The study will involve women aged 18 and older, who are at least 12 weeks pregnant or less than 12 weeks postpartum, and live in Nottinghamshire, UK. Participants will need to understand and speak English and have access to the internet and a smartphone.

If you join the study, you’ll help us understand how well the app works and if there are any issues while using it. The initial phase will focus on recruiting about 125 participants over 14 months, starting with a smaller pilot group to test the process. It’s important to note that women with certain mental health conditions, such as severe anxiety or other psychiatric disorders, will not be eligible to participate. This study is a step toward improving support for women dealing with depression and anxiety during and after pregnancy.

Gender

FEMALE

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.

About Blueskeye Ai

BlueSkye AI is an innovative clinical trial sponsor dedicated to advancing healthcare through the integration of artificial intelligence and data analytics. By leveraging cutting-edge technology, BlueSkye AI aims to enhance the efficiency and accuracy of clinical trials, facilitating the development of new therapies and improving patient outcomes. With a focus on collaboration and transparency, the organization strives to empower researchers and stakeholders, ensuring that every trial is conducted with the highest standards of integrity and scientific rigor. BlueSkye AI is committed to transforming the clinical research landscape, driving breakthroughs that will shape the future of medicine.

Locations

Nottingham, Nottinghamshire, United Kingdom

Nottingham, , United Kingdom

Patients applied

0 patients applied

Trial Officials

Neil Nixon, MBBS

Principal Investigator

School of Medicine, University of Nottingham and Nottinghamshire Healthcare NHS Trust

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported