bWell Cognitive Remediation for Major Depressive Disorder

Overseen By Trisha Chakrabarty, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must be taking: Antidepressants, Stimulants

Must not be taking: Benzodiazepines, Cannabis

Disqualifiers: Severe depression, Neurological disorders, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new virtual reality tool designed to assist individuals with Major Depressive Disorder (MDD). The researchers aim to determine if this tool is user-friendly, enjoyable, and effective in enhancing cognitive function (thinking skills) for those with MDD. Participants will engage in either cognitive exercises through the VR tool, known as bWell Cognitive Remediation, or experience relaxing VR scenes twice a week for eight weeks. Individuals diagnosed with MDD, who experience cognitive difficulties, and are on a stable treatment plan may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatments and contribute to the advancement of mental health care.

What prior data suggests that the bWell Cognitive Care Platform is safe for patients with Major Depressive Disorder?

Research shows that the bWell Cognitive Remediation platform, which uses virtual reality (VR) to treat depression, is generally well-tolerated. Previous studies have found that tools like these can help improve thinking skills and reduce depression symptoms. This suggests that similar VR-based treatments, like bWell, might also be safe to use.

Although specific safety data for bWell Cognitive Remediation is not yet available, VR-based tools are usually considered low-risk. They involve interactive tasks that typically do not cause major side effects. People who have used VR cognitive programs in the past have generally found them acceptable and easy to use, experiencing minimal discomfort or negative effects.

Overall, while the exact safety details of bWell are still being studied, using VR and cognitive tasks for depression treatment has not raised major safety concerns so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Major Depressive Disorder, such as antidepressants and psychotherapy, bWell Cognitive Remediation is a non-pharmacological approach that focuses on enhancing cognitive functions like memory and attention. This treatment involves interactive sessions that patients complete twice a week, aiming to directly improve the brain's processing abilities, which can be affected by depression. Researchers are excited about this method because it offers a novel way to tackle depression by potentially improving cognitive deficits without the side effects often associated with medication.

What evidence suggests that this trial's treatments could be effective for Major Depressive Disorder?

Research has shown that cognitive exercises can help people with major depressive disorder (MDD) think more clearly, feel less depressed, and improve their social skills. One study found that patients who performed these exercises had better focus and decision-making skills. In this trial, participants will be assigned to either the bWell Cognitive Remediation program or a VR Experience. The bWell Cognitive Remediation program, which uses virtual reality, might offer similar benefits to those observed in previous studies. Early results suggest that virtual reality programs like bWell-D could effectively improve thinking skills in people with MDD. Although these methods are still under evaluation, they show promise in managing depression symptoms. ^{1 4 5 6 7}

Who Is on the Research Team?

Trisha Chakrabarty, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 19 and 55 years old.

Meeting the DSM-5 criteria for MDD as assessed by a standardized psychiatric interview (SCID-5-RV) conducted by a trained clinician

Euthymic or mildly depressed (MADRS score < 19)

Exclusion Criteria

Other psychiatric disorder considered primary

Meeting DSM-5 criteria for alcohol or substance use disorder within three months prior to randomization

Presence of artificial heart valve, ear or eye implant, brain aneurysm clip, implanted electronic device, coil, catheter, or filter in any blood vessel, orthopedic hardware, shrapnel, bullets, or other metal fragments, recent surgery or medical procedure, metallic prostheses

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual)

Initial Assessment

Participants complete an initial bWell cognitive assessment session including rating scales and a neuropsychological test battery

1 week

1 visit (in-person)

Treatment

Participants are randomized to either bWell cognitive remediation or VR scenes experience, with sessions twice a week for eight weeks

8 weeks

16 visits (in-person)

Follow-up

Participants undergo MRI scans and complete assessments of cognitive and psychosocial functioning

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• bWell Cognitive Remediation
• VR Experience

How Is the Trial Designed?

Group I: bWell Cognitive Remediation Active Control 1 Intervention

Patients with Major Depressive Disorder who will complete cognitive remediation sessions using bWell twice a week for eight weeks.

Group II: VR Experience Placebo Group 1 Intervention

Patients with Major Depressive Disorder who will experience various VR scenes twice a week for eight weeks.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

National Research Council, Canada

Collaborator

Trials

3

Recruited

230+

Simon Fraser University

Collaborator

Trials

59

Recruited

12,500+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12438982/

Effectiveness of cognitive remediation in subjects with major ...

Outcomes were measured with validated instruments by blind assessors and included cognitive performance, depressive symptoms, and psychosocial functioning.

2.

games.jmir.org

games.jmir.org/2023/1/e43904/

Co-design of a Virtual Reality Cognitive Remediation Program ...

This study aimed to develop the first prototype VR cognitive remediation program for MDD (“bWell-D”). This study gathered qualitative data from end users.

3.

nrc-publications.canada.ca

nrc-publications.canada.ca/eng/view/object/?id=e05dbd27-03df-49e8-8251-fbeab0399a6c

Co-design of a virtual reality cognitive remediation program for ...

Objective: This study aimed to develop the first prototype VR cognitive remediation program for MDD (“bWell-D”). This study gathered qualitative ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10466045/

Long-term outcomes of an internet-delivered cognitive ... - PMC

Between the pre-treatment and 2-year follow-up assessments, there was a reduction in cognitive deficits and rumination, while there was an ...

5.

sciencedirect.com

sciencedirect.com/org/science/article/pii/S229192792500039X

Considering Theory-Based Gamification in the Co-Design ...

Although cognitive remediation in patients with MDD appears to improve performance in select cognitive domains, this has not translated to ...

6.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06546917/bwell-d-pilot-randomized-controlled-trial

bWell-D Pilot Randomized Controlled Trial

The goal of this clinical trial is to determine the acceptability, feasibility, and validity of the bWell Cognitive Care Platform for ...

7.

biologicalpsychiatryjournal.com

biologicalpsychiatryjournal.com/article/S0006-3223(25)00524-4/pdf

189. bWell-D: Novel Virtual Reality Cognitive Remediation ...

Background: Cognitive deficits are a major determinant of functional outcomes in Major Depressive Disorder (MDD). Existing cognitive assessment tools may ...