RecruitingNAINTERVENTIONAL

bWell-D Pilot Randomized Controlled Trial

This study looks at a new virtual reality (VR) tool called bWell-D, which helps with thinking skills in people with depression. Researchers want to know if people with depression find the VR assessments and training acceptable, easy to use, and helpful. Some participants will use the bWell-D training, while others will experience VR scenes without specific tasks. Everyone will have assessments at different times, including brain scans, to see how bWell-D might help. The study aims to gather information to see if this VR approach could be a useful new way to support people with depression.

At a glance

Status

Recruiting

Phase

Sponsor

University of British Columbia

Enrolment target

Start

01 Jan 2025

Estimated completion

01 Aug 2026

Depressive Disorder, Major Cognitive Dysfunction

What is this study about?

This study is a pilot, which means it's a small-scale effort to try out a new approach before a bigger study. It's looking at a new system called bWell-D, which uses virtual reality (VR) — like stepping into a computer-generated world — to help people with depression. This VR tool is designed to assess and improve thinking skills, sometimes called 'cognitive function', which can be affected by depression. The main idea is to see if this new VR tool is something that people with depression find manageable and helpful to use.

The researchers want to answer two key questions: Do people with depression find the bWell-D VR assessments easy to complete and acceptable? And do they find the bWell-D VR training, which lasts for eight weeks, also easy to manage and acceptable? By answering these questions, the study hopes to understand if bWell-D could be a promising new option for supporting people with depression and their thinking abilities.

This study is important because it explores new ways to help people living with depression. If the bWell-D system proves to be acceptable and shows potential for improving thinking skills, it could lead to bigger studies and potentially offer a new treatment option in the future. It's a step towards finding innovative and engaging ways to improve mental well-being.

Key takeaways

This study explores a new VR tool (bWell-D) for thinking skills in people with depression.
It aims to see if the VR assessments and training are easy to use and acceptable.
Participation involves VR sessions twice a week for eight weeks and assessments.
Brain scans (EEG and MRI) will be used to understand potential effects.
You won't know if you're in the active training group or the VR scenes group.
The study is a pilot to gather initial information for future research.

Who may be eligible?

To join this study, you need to be between 19 and 55 years old and have been diagnosed with major depressive disorder. You can't be suffering from severe depression right now; your depression should be mild or you should be feeling well. It's also important that you feel your thinking skills, like memory or focus, are not as sharp as they could be.

If you take antidepressant medication, you need to have been on a stable dose for at least four weeks before starting the study. The same goes for any other regular medications you take. If you have therapy, it needs to have been stable for at least eight weeks. There are some conditions that would prevent you from joining, such as other significant ongoing health conditions that might affect your thinking, or substance use issues in the last three months.

The researchers want to make sure the VR experience is safe and comfortable for everyone, so they're not including people with more severe depression who might feel unwell using VR, or people with a history of seizures. You also need to be able to follow instructions in English.

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 between 19 and 55 years old?
Do you have a diagnosis of major depressive disorder?
Are your depression symptoms currently mild, or are you feeling well?
Do you feel that your thinking skills (like memory or attention) could be better?
Have you been on a stable dose of any regular medications for at least 4 weeks?
Are you able to understand and follow instructions in English?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have a virtual check-up to see if you're a good fit. If you are, you'll come in for an initial session where you'll wear a VR headset for an assessment to check your thinking skills. You'll also complete some questionnaires about your mood and how well you're managing daily life.

After this, you'll be randomly placed into one of two groups. One group will use the bWell VR training twice a week for eight weeks, with each session lasting about 40 minutes. The other group will experience different VR scenes that don't involve specific tasks. Throughout the study, you'll have check-ups at the beginning, in the middle, and at the end of the eight weeks. These check-ups will involve more questionnaires, assessments of your thinking skills, and some brain scans (EEG and two MRI scans). We will also ask you about how you found the VR experience, if you enjoyed it, and how engaged you felt.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as gaining access to a new virtual reality tool that might help improve your thinking skills and overall well-being. However, there's no guarantee that you will personally benefit from the intervention. Potential risks are generally low, but some people might experience mild discomfort or motion sickness (cybersickness) while using VR, similar to feeling a bit dizzy or nauseous. Participants are completely free to withdraw from the study at any time without giving a reason, and this will not affect their regular medical care.

Locations (1)

UBC Centre for Brain Health
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is 'virtual reality'?

Virtual reality is a computer-generated world that you can experience using special headsets, making you feel like you're actually there.

What are 'thinking skills'?

Thinking skills, or cognitive function, include things like memory, attention, problem-solving, and how quickly you process information.

Will I know if I'm getting the active bWell-D training or just VR scenes?

No, you won't know which group you're in. The researchers want to see how everyone responds without that expectation, as both methods are thought to have potential benefits.

What is an EEG or an MRI scan?

An EEG (electroencephalogram) measures brain activity with sensors on your scalp. An MRI (magnetic resonance imaging) is a type of scan that uses strong magnets and radio waves to create detailed images of your brain.

How much time will I need to commit to the study?

You'll have an initial assessment, then two 40-minute VR sessions per week for eight weeks, plus assessments at the start, middle, and end, including some scans.

How to find out more

Trisha Chakrabarty, MD

trisha.chakrabarty@ubc.ca 6048227512 Official trial record

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