RecruitingNot ApplicableNCT06364488

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

Sponsor

BlueSkeye AI

Enrollment

125 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Depression Anxiety Anhedonia Perinatal Depression Depression, Postpartum Anxiety in Pregnancy

Summary

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a smartphone app called TrueBlue designed to support the mental health and wellbeing of pregnant women and new mothers in the UK, particularly those at risk of or experiencing depression. **You may be eligible if...** - You are 18 years old or older - You are fluent in English (spoken and written) - You are at least 12 weeks pregnant OR gave birth in the last 12 weeks - You have access to the internet and a compatible smartphone - You have a GP (family doctor) registered in Nottinghamshire **You may NOT be eligible if...** - You have a current or previous diagnosis of a serious psychiatric condition other than depression or generalised anxiety (e.g., bipolar disorder, psychosis, eating disorders, substance abuse disorders, autism spectrum condition) - You are under 18 years old - You cannot communicate in English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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