An Immersive and Interactive Platform for Cognitive Assessment and Rehabilitation (bWell): Design and Iterative Development Process.
Vincent Gagnon Shaigetz, Catherine Proulx, Anne Cabral...
https://pubmed.ncbi.nlm.nih.gov/34730536Actively Recruiting
Phase Not Applicable
Age: 19Years - 55Years
All Genders
Healthy Volunteers
ID06546917
The bWell Cognitive Care Platform: A Pilot Feasibility Study in Patients With Depression
Led by University of British Columbia · Updated on 2026-04-28
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
S
Simon Fraser University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the bWell Cognitive Care Platform for Depression (bWell-D), a virtual reality (VR) tool for cognitive assessment and remediation in adults with Major Depressive Disorder (MDD). The study focuses on whether patients find the cognitive testing and 8-week remediation program feasible, tolerable, and acceptable. The study includes both depressed patients and healthy volunteers for comparison. Participants diagnosed with MDD, who are currently euthymic or mildly depressed, will first complete a virtual cognitive assessment including rating scales and neuropsychological tests. They will then be randomly assigned to either an active bWell cognitive remediation group, involving twice-weekly 40-minute sessions with progressively challenging cognitive tasks over 8 weeks, or a control group experiencing passive VR scenes on the same schedule. Outcome assessors will be blinded to group assignments. Throughout the study, participants will complete clinical, cognitive, and functional assessments at baseline, midpoint, and end of the 8-week intervention, along with EEG recordings and two MRI scans. Measures of tolerability, engagement, and enjoyment will also be collected. Participants may opt for additional neurophysiology testing. Healthy volunteers will undergo a single assessment session for comparison. The total study period includes screening, intervention, and follow-up assessments lasting approximately 8 weeks.
CONDITIONS
Brief Title
bWell-D Pilot Randomized Controlled Trial
Who Can Participate
Age: 19Years - 55Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Be between 19 and 55 years old
- Have a diagnosis of Major Depressive Disorder confirmed by a standardized psychiatric interview
- Be currently euthymic or mildly depressed with a MADRS score less than 19
- Report subjective cognitive difficulties with a PDQ-D-20 score greater than 20
- Be on stable antidepressant medication for at least 4 weeks if applicable
- Be on stable psychotherapy for at least 8 weeks if applicable
- If diagnosed with ADHD, be on stable stimulant treatment for at least 4 weeks
- Be able to follow written and verbal instructions in English
You will not qualify if you...
- Have moderate to severe depression
- Have significant neurological disorders, head trauma, or unstable medical conditions affecting cognition
- Have other primary psychiatric disorders such as anxiety or psychotic disorders
- Have alcohol or substance use disorder within 3 months prior to randomization
- Use benzodiazepines more than three times per week or within 24 hours of visits
- Use cannabis or alcohol within 24 hours, or tobacco within 30 minutes of visits
- Have suicidal ideation or history of self-harm
- Have completed previous cognitive remediation
- Have contraindications for MRI such as electronic implants, pacemakers, metal in eyes, pregnancy, certain tattoos, or intrauterine devices
- Have recent surgery, medical procedures, or metallic prostheses
- For healthy controls: history of psychiatric disorder, neurological disorder, or physical mobility issues limiting arm or neck movement
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 virtual assessment visit
Baseline Assessment
Duration - 1 day
Participants complete initial cognitive assessments, rating scales for depression, anxiety, cognitive and psychosocial functioning, and undergo MRI and EEG scans.
1 in-person visit for assessments and scans
Treatment
Duration - 8 weeks
Participants are randomized to either bWell cognitive remediation or a VR experience control group. They complete 40-minute sessions twice a week for 8 weeks, with EEG assessments at baseline, midpoint, and end of treatment.
Two visits per week for 8 weeks (in-person or virtual depending on site)
Post-Treatment Assessment
Duration - Up to 2 weeks
Participants repeat cognitive assessments, rating scales, and undergo follow-up MRI scans within two weeks after treatment ends.
1 to 2 in-person visits for assessments and MRI scans
Trial Site Locations
Total: 1 location
1
UBC Centre for Brain Health
Vancouver, British Columbia, Canada, V6T 1Z3
Actively Recruiting
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Research Team
T
Trisha Chakrabarty, MD
F
Faranak Farzan, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Co-design of a Virtual Reality Cognitive Remediation Program for Depression (bWell-D) With Patient End Users and Clinicians: Qualitative Interview Study Among Patients and Clinicians.
Maria Elena Hernandez Hernandez, Erin Michalak, Nusrat Choudhury...
https://pubmed.ncbi.nlm.nih.gov/37027183