Actively Recruiting
bWell-D Pilot Randomized Controlled Trial
Led by University of British Columbia · Updated on 2026-04-28
40
Participants Needed
1
Research Sites
82 weeks
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
The goal of this clinical trial is to determine the acceptability, feasibility, and validity of the bWell Cognitive Care Platform for Depression (bWell-D), a novel Virtual Reality (VR) cognitive assessment and remediation tool, in depressed populations. The main questions are: * Do patients with Major Depressive Disorder (MDD) find the bWell-D cognitive assessment battery and protocol feasible, tolerable, and acceptable? * Do patients with Major Depressive Disorder (MDD) find the 8 week bWell-D remediation protocol feasible, tolerable, and acceptable? Following initial cognitive assessment, researchers will assess feasibility outcomes in the bWell remediation arm to a VR scenes experience arm to learn more about the feasibility of bWell for cognitive assessment and remediation. Patients will: * Complete an initial bWell cognitive assessment session * Randomized to either receive bWell cognitive remediation or a VR scenes experience twice a week for eight weeks * Complete cognitive/functional/clinical assessments and EEG at baseline, midpoint and endpoint of the remediation protocol, as well as two MRI scans and measures of tolerability, engagement, and enjoyment
CONDITIONS
Official Title
bWell-D Pilot Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 19 to 55 years
- Diagnosed with Major Depressive Disorder (MDD) by a standardized psychiatric interview
- Currently euthymic or mildly depressed with a MADRS score less than 19
- Reporting cognitive difficulties with a PDQ-D-20 score greater than 20 at enrollment
- On stable antidepressant therapy for at least 4 weeks before randomization if using medication
- On stable adjunct psychotherapy for at least 8 weeks before randomization if undergoing therapy
- On a stable dose of stimulants for at least 4 weeks if diagnosed with ADHD
- Able to follow written and verbal instructions in English
You will not qualify if you...
- Moderate to severe depression due to acceptability concerns
- Significant neurological disorders, head trauma, or unstable medical conditions affecting cognition
- Primary psychiatric disorders other than MDD
- Substance use disorder within 3 months before randomization
- Frequent benzodiazepine use or use within 24 hours of baseline or close-out visits
- Use of cannabis or alcohol within 24 hours or tobacco within 30 minutes of baseline or close-out visits
- Suicidal thoughts or self-harm behavior
- Previous cognitive remediation therapy
- Contraindications to MRI including retained electronic implant wires, pacemakers, metal in eyes, aneurysm clips, pregnancy, certain tattoos, or metal IUDs
- Possible exclusion for artificial heart valves, implants, aneurysm clips, electronic devices, metal fragments, recent surgery or tattoos, or other metallic prostheses based on MRI safety review
- Healthy controls must have no history of psychiatric disorder, no significant neurological or medical conditions affecting cognition, and no physical mobility limitations affecting arm or neck movement
AI-Screening
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Trial Site Locations
Total: 1 location
1
UBC Centre for Brain Health
Vancouver, British Columbia, Canada, V6T 1Z3
Actively Recruiting
Research Team
T
Trisha Chakrabarty, MD
CONTACT
F
Faranak Farzan, PhD
CONTACT
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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