TrueBlue mobile app for tracking depression and anxiety during pregnancy and after birth
TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
This project will test whether the TrueBlue smartphone app can monitor symptoms of depression, anxiety, and loss of pleasure in people who are pregnant or within 12 weeks after giving birth.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | BlueSkeye AI Industry-sponsored |
| Locations | 2 sites (Nottingham, Nottinghamshire and 1 other locations) |
| Trial ID | NCT06364488 on ClinicalTrials.gov |
What this trial studies
This early-phase interventional study will recruit adults in the perinatal period (between 12 weeks of pregnancy and up to 12 weeks postpartum) across NHS sites in Nottinghamshire to use the TrueBlue app over a 12-week period. An initial pilot of up to 12 participants will check recruitment, usability, and any device-related adverse events before expanding to a total target of 125 participants over 14 months. Participants will complete two app tasks per week that involve reading or speaking while the app records face and voice data, and they will complete four validated questionnaires (PHQ-9, EPDS, GAD-7, TEPS) every two weeks. Adverse events will be actively monitored at weeks 6 and 12 and reviewed for possible links to app use.
Who should consider this trial
Good fit: Adults aged 18 or older who are between 12 weeks pregnant and 12 weeks postpartum, fluent in English, have capacity to consent, have a GP in Nottinghamshire, and have internet access plus a compatible smartphone (with limited devices supplied by the study if needed).
Not a fit: People with current or prior clinically diagnosed psychiatric disorders other than depression or generalized anxiety (for example psychosis, bipolar disorder, personality disorders, substance or eating disorders), those with certain neurological or developmental diagnoses, non-English speakers, or those without smartphone/internet access are unlikely to benefit from this app-based monitoring approach.
Why it matters
Potential benefit: If successful, the app could provide convenient remote monitoring of mood changes in the perinatal period and help identify people who may need earlier clinical support.
How similar studies have performed: Related digital mood-monitoring apps have shown promising results for remote symptom tracking, but automated face-and-voice analysis in perinatal populations is still an emerging and relatively untested approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nottingham, Nottinghamshire and 1 other locations
- Nottingham University Hospitals NHS Trust — Nottingham, Nottinghamshire, United Kingdom (Not_yet_recruiting)
- Nottinghamshire Healthcare NHS Foundation Trust — Nottingham, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Neil Nixon, MBBS — School of Medicine, University of Nottingham and Nottinghamshire Healthcare NHS Trust
- Study coordinator: John Michaelis, BSc
- Email: john@blueskeye.com
- Phone: 01689 856664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.