RecruitingInterventional

A trial of a patient app and care team interface designed to facilitate shared decision making for people with bipolar disorder

This study is looking at a new digital platform for people with bipolar disorder. The app, created by Fora Health, helps patients track their condition and communicate with their care team, aiming to improve how they manage their treatment. Bipolar disorder can be challenging to manage, and sometimes people don't stick to their treatment plans, which can lead to setbacks. This study will involve 120 people, some using the app alongside their usual care, and others receiving only their usual care, for six months. Researchers want to see if the app helps people engage more with their treatment and if it's easy to use and helpful. This could lead to better support for people with bipolar disorder in the future.

At a glance

Status

Recruiting

Enrolment target

120

Start

01 Apr 2026

Estimated completion

31 Mar 2027

Bipolar disorder

What is this study about?

Bipolar disorder is a long-term condition that causes big shifts in a person's mood, from very high (mania) to very low (depression). Even though treatments can help a lot, it can be hard for people to stick to their medication and care plans, which can sometimes lead to more difficult periods or hospital stays.

This study, taking place at South London and Maudsley NHS Foundation Trust, wants to see if a new digital tool, an app from a company called Fora Health, can make a difference. The idea behind this app is to help patients and their doctors work together more closely on treatment decisions. This approach, called 'shared decision making', aims to get patients more involved and help them feel more in control of their health. The app could allow people to keep track of their mood and other important information, and easily share this with their healthcare team.

The main goals of this study are to make sure the app works well for people with bipolar disorder, see if they find it useful and easy to use, and check if it actually helps them manage their condition better. If this app proves to be effective, it could become a valuable part of mental health care in the future, providing ongoing support between doctor's appointments.

Key takeaways

Tests a new app for people with bipolar disorder.
Aims to improve patient-doctor teamwork and treatment involvement.
Participation involves remote meetings over six months.
Could lead to better long-term support for bipolar disorder.
You continue your usual care and medication.
Your safety and well-being are a priority throughout the study.

Who may be eligible?

To join this study, you need to be 18 years or older and have a diagnosis of bipolar disorder (Type I, Type II, or 'not otherwise specified') that started before you turned 50. You must be receiving care from the South London and Maudsley NHS Trust and have a doctor or clinician who agrees to be part of the study.

You also need to be able to give your informed consent, meaning you understand what the study involves and agree to participate. You will also need access to a device (like a smartphone or tablet) with internet access that can run the Fora Health app.

You cannot join if you are going through an acute bipolar episode (a very strong period of mania or depression) right now, have a severe problem with alcohol or drugs, or have a brain-related condition. You also shouldn't be involved in another clinical study that might clash with this one.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of bipolar disorder?
Are you currently receiving care under South London and Maudsley NHS Trust?
Do you have a doctor who would be willing to support your participation?
Do you have an internet-enabled device (like a phone or tablet) that can run apps?
Are you currently stable and not in an acute mood episode?

Answer every question to see your result.

What does participation involve?

If you join this study, it will last for six months. You'll be randomly put into one of two groups. One group will use the Fora Health app alongside their usual care, and the other group will continue with their usual care without using the app. You won't get to choose which group you are in.

Over the six months, you'll have six meetings with the study team. All these meetings will happen remotely, meaning you won't need to travel – they'll likely be video calls, for example, using Microsoft Teams. These meetings will include an initial check to see if you're suitable for the study, a baseline assessment where you'll complete questionnaires, and then further assessments at 3, 8, 13, and 26 weeks. These assessments will help the researchers understand your symptoms and how you're engaging with the app, if you're in that group. The study aims to make these visits flexible and keep the questionnaires to what's necessary.

Potential risks and benefits

Taking part in this study could offer some potential benefits. Digital tools like the Fora Health app might give you continuous support between your appointments, which could help reduce difficult periods and hospital stays. Similar apps have shown promise in previous studies for improving involvement with treatment and reducing symptoms in people with depression. Even if you don't use the app, your participation will help improve future care for people with bipolar disorder. However, there are some potential risks. You might feel a bit of emotional distress when answering questions about your mood or condition. The study team will make sure you're supported, offered breaks, and directed to help if needed. The time commitment might also feel like a burden, but the team will work with you to make scheduling flexible. There's also a small chance you might not like the app or find it unhelpful. Throughout the study, your well-being will be monitored closely by experienced clinicians, and you can withdraw from the study at any time.

Locations (1)

Bethlem Royal Hospital
Approximate
Beckenham, England

Common questions

What is 'shared decision making'?

It's when you and your doctor work together to make choices about your treatment, making sure your preferences and needs are considered alongside medical advice.

Will I have to pay for the app?

No, if you're in the group using the app for the study, you will not have to pay for it.

Can I still take my regular medication if I join the study?

Yes, you will continue with your usual treatment and medication throughout the study, whether you use the app or not.

What if my doctor stops supporting me in the study?

You can still continue with your study visits, though if you're in the app group, you would stop using the Fora Health app.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

How to find out more

Allan Young

a.young@imperial.ac.uk +44 (0)2078485895 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.