TrueBlue Clinical Study - Investigating the Use of a Mobile Phone App TrueBlue for Monitoring Depression and Anxiety
The TrueBlue study is exploring a new mobile phone app designed to help monitor depression and anxiety. This research focuses on women who are pregnant (from 12 weeks onwards) or have recently given birth (up to 12 weeks postpartum). We want to understand how safe, easy to use, and helpful the TrueBlue app is compared to standard measures. It will involve a small pilot phase first to check everything is working well, then a larger group of 125 participants over 14 months. The study is taking place across different healthcare sites in Nottinghamshire, UK. The aim is to see if this app could be a good way to keep an eye on mood changes during this important time.
At a glance
What is this study about?
The TrueBlue study is looking into a new mobile phone app, also called TrueBlue, which aims to help people keep track of their mood. Specifically, this study is for women who are either pregnant (starting from 12 weeks of pregnancy) or have recently had a baby (up to 12 weeks after birth) and are experiencing feelings of depression or anxiety.
The main goals of this study are to see if the app is safe, easy to use, and if people find it helpful. We also want to check if the information the app gathers about mood matches up with information from standard questionnaires used by doctors. This research is important because it could help us find new ways to support mental health during pregnancy and after childbirth.
Initially, a small group of people will try out the app in a pilot phase. This helps us make sure everything works smoothly, like how easy it is to sign up, use the app, and handle any unexpected issues. After this, we will invite more people to join the study, aiming for a total of 125 participants from healthcare providers in Nottinghamshire, such as Nottinghamshire Healthcare NHS Foundation Trust (NHFT) and Nottingham University Hospitals NHS Trust (NUH), as well as local GP surgeries.
Key takeaways
- The TrueBlue study is testing a new app for monitoring depression and anxiety.
- It's for pregnant women (12+ weeks) and new mothers (up to 12 weeks postpartum) in Nottinghamshire.
- Participation involves using the app for 12 weeks to complete short tasks and questionnaires.
- The goal is to see if the app is safe, easy to use, and helpful for tracking mood.
- Your regular medical care will not be affected by taking part.
- You can stop participating at any time.
Who may be eligible?
To be part of the TrueBlue study, you need to be a woman aged 18 or over. You must also be at least 12 weeks pregnant or have given birth within the last 12 weeks. It’s important that you can understand and speak English well and have internet access, along with a smartphone that works with the app. You also need to have a registered GP within Nottinghamshire.
There are certain reasons why you might not be able to join. For example, if you have other mental health conditions apart from depression or general anxiety, such as bipolar disorder, psychosis, or an eating disorder. If you’ve had these conditions in the past, you might not be eligible. We also can't include people with certain long-term conditions like Autism Spectrum Disorder, ADHD, or Parkinson's Disease.
- Are you 18 years old or older?
- Are you at least 12 weeks pregnant, or have you given birth less than 12 weeks ago?
- Do you live in Nottinghamshire and have a local GP?
- Do you have a smartphone compatible with apps and internet access?
- Do you feel comfortable speaking and reading in English?
- Have you been diagnosed only with depression or general anxiety, and not other serious mental health conditions in the past or now?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join the TrueBlue study, you'll use the TrueBlue app on your smartphone for 12 weeks. Each week, you'll be asked to complete two short tasks on the app. This will involve you either reading something or speaking into your phone while the app records your face and voice. Every two weeks, you'll also fill out four different questionnaires on the app that help us understand how you're feeling about your mood, enjoyment, and anxiety.
We will check in with you at week 6 and week 12 to see how you are getting on and if you've had any new or recurring health problems. You will also be encouraged to report any health concerns you might have at any other time. The total study duration for each person will be 12 weeks of using the app, plus some initial set-up and final checks. There are no study visits or medication involved in this study, just your use of the app.
Potential risks and benefits
Locations (2)
- Nottingham University Hospitals NHS TrustNottingham, United Kingdom· Not yet recruiting
- Nottinghamshire Healthcare NHS Foundation TrustNottingham, United Kingdom· Recruiting
Common questions
What is the TrueBlue app?
It's a mobile phone app designed to help keep track of your mood, especially feelings of depression and anxiety.
Who can take part in this study?
Women aged 18 or over who are at least 12 weeks pregnant or have had a baby within the last 12 weeks, living in Nottinghamshire.
How long will I be involved in the study?
You'll use the app for 12 weeks, with weekly checks and questionnaires every two weeks.
Do I need my own smartphone?
Yes, you generally need a compatible smartphone and internet access. In some cases, a phone might be provided.
Will this replace my usual doctor's care?
No, this app is for monitoring and research; it doesn't replace your regular medical care or advice from your GP or midwife.
How to find out more
John Michaelis, BSc
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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