CompletedInterventional

MILESTONE (Emotional Cognitive Bias Modification in Depression): a trial of psychological therapy in addition to treatment with an SSRI for depression

Depression is a common condition that can cause low mood, tiredness, and worry. Antidepressant medications called SSRIs help many people, but they often work best when paired with psychological support. The MILESTONE study investigates whether a short online computer programme can help SSRIs work more effectively. When people feel depressed, their brains often focus more easily on negative cues, such as frowning faces. This study tests an online training activity designed to help the brain notice positive emotional expressions instead. Participants take their usual SSRI medication and complete five short online sessions at home. They then attend a specialised brain scan (an fMRI scan) in Cardiff to see if brain activity has changed, followed by a final online questionnaire six weeks later. This research could help doctors develop quick, accessible digital tools to support people starting treatment for depression.

At a glance

Status

Completed

Sponsor

University of Bristol

Enrolment target

Start

15 Sep 2021

Estimated completion

28 Feb 2024

Depression

What is this study about?

Depression affects millions of people across the UK. It can cause persistent feelings of sadness, poor sleep, low energy, and a loss of interest in everyday activities. While selective serotonin reuptake inhibitors (SSRIs) are standard and helpful antidepressant medicines, they do not work fully for everyone. Evidence shows that medicines often work best when combined with psychological therapy, but researchers want to find the simplest and most accessible ways to deliver this extra support.

When someone experiences depression, it can change how their brain processes everyday social signals. People may unintentionally focus more on negative signs, like unhappy facial expressions, while missing friendly or positive ones. The MILESTONE trial is testing a technique called Emotional Cognitive Bias Modification (CBM). This is a simple computer-based task that gently trains the brain to spot positive emotional cues. Researchers want to find out whether doing this alongside taking an SSRI helps people recover more quickly.

To see how the training works inside the brain, participants will have a non-invasive MRI scan while completing a task. The study compares people who receive the active brain training against those who receive a neutral comparison version. By looking at changes in brain activity, the researchers hope to understand the biology of depression better and discover whether short digital therapies can become a standard, convenient add-on to GP care.

Key takeaways

Tests whether a 5-session online brain-training task helps SSRI antidepressants work better.
Open to adults aged 18 to 55 who have recently started an SSRI for depression.
Includes five online sessions at home, one safe MRI brain scan in Cardiff, and a 6-week online follow-up.
Participation is voluntary and does not replace your normal GP care or medication.
Helps scientists learn how depression affects the brain and how to improve future mental health care.

Who may be eligible?

This study is open to men and women aged 18 to 55 who are going through a new or first episode of depression. You must have recently been prescribed an SSRI antidepressant by your doctor and scored above a certain level on a standard mood questionnaire. You should not have taken antidepressants or had intensive psychological therapy in the past six months, and you will need a smartphone, tablet, or computer to complete the online tasks.

Because the study involves an MRI brain scan, there are strict safety rules. You cannot take part if you have certain metal objects inside your body that cannot be removed, such as a heart pacemaker, metal clips, or dental braces. People with large tattoos on the head or neck, epilepsy, type 1 diabetes, or conditions causing severe dizziness or temperature problems are also excluded.

Additionally, this study is not suitable for people who are currently under specialist hospital psychiatric care, or those living with other conditions such as bipolar disorder, psychosis, dementia, or active drug or alcohol dependency.

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 aged between 18 and 55?
Have you recently been prescribed an SSRI antidepressant by your doctor?
Have you been free from antidepressant medication and intensive therapy for the past 6 months?
Do you have a smartphone, tablet, or computer with internet access?
Are you safe to have an MRI scan (no pacemakers, braces, or metal implants)?

Answer every question to see your result.

What does participation involve?

Taking part in the MILESTONE study involves several simple steps over about two months. First, you will have a 10 to 15-minute telephone chat with a researcher to see if the study is right for you. If it is, you will be invited to a 60-minute appointment to talk through the details, sign a consent form, and fill in some initial questionnaires.

If you join, you will be randomly placed into one of two groups by a computer. One group receives the active emotional brain-training programme, while the other receives a comparison version. You will continue taking your prescribed SSRI medication as directed by your GP. You will then complete five short online training sessions from home on your phone, tablet, or laptop.

After finishing the online sessions, you will visit the Cardiff University Brain Research Imaging Centre (CUBRIC) for an fMRI brain scan. During the scan, you will lie comfortably while completing simple viewing tasks. Around six weeks later, you will fill in a final online questionnaire at home to see how you are feeling. At the end of the study, the researchers will let you know which group you were in.

Potential risks and benefits

This research may not provide direct health benefits to you, as the brain scan is done purely for scientific purposes and does not replace medical care. However, many people find taking part in clinical studies interesting, and your time will help scientists understand depression better and improve future treatments. The risks are very low. An MRI scan is painless and does not use radiation, though the scanner can feel noisy and enclosed, and some people may feel slightly tired during the computer tasks. Joining the study is entirely voluntary, and you are free to stop at any point without it affecting your usual NHS medical care or prescriptions.

Locations (1)

University of Bristol
Approximate
Bristol, England

Common questions

Do I have to stop taking my antidepressant tablets to take part?

No. You must continue taking your prescribed SSRI medication exactly as advised by your doctor throughout the study.

What is an fMRI scan and does it hurt?

An fMRI scan is completely painless and safe. It uses harmless magnetic fields and radio waves—not radiation—to take pictures of your brain while you do simple tasks. It can be loud, so you will be given earplugs or headphones.

Can I do the online sessions from home?

Yes. All five training sessions can be done at home using your own smartphone, laptop, or home computer.

Where does the brain scan take place?

The scan takes place at the Cardiff University Brain Research Imaging Centre (CUBRIC) in Cardiff.

What happens if I decide I no longer want to participate?

You are free to leave the trial at any time. You do not need to give a reason, and your decision will never affect your regular NHS treatment or relationship with your doctor.

How to find out more

Ian Penton-Voak

i.s.penton-voak@bristol.ac.uk +44 (0)117 928 8667 Official trial record

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