bWell-D Pilot Randomized Controlled Trial

Recruiting now · Not applicable

Conditions studied: Depressive Disorder, Major, Cognitive Dysfunction

In brief

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

Key facts

Study ID

NCT06546917

Run by

University of British Columbia

People needed

40

Starts

2025-01-01

Expected to finish

2026-08-01

Last updated by the study team

2026-04-28

Who can join

Age: 19 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 19-55 years old
• Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD as assessed by a standardized psychiatric interview (SCID-5-RV) conducted by a trained clinician.
• Patients will be euthymic or mildly depressed (defined by a Montgomery-Asberg Depression Rating Scale [MADRS] score < 19)
• Patients will report subjective cognitive deficits at baseline, as indicated by a total Perceived Deficits Questionnaire - Depression 20 [PDQ-D-20] score > 20 at study enrollment.
• If using antidepressants, participants will be on stable antidepressant therapy for at least 4 weeks prior to randomization. All concomitant doctor-prescribed medications must be at a stable dose for 4 weeks prior to the randomization visit.
• If undergoing psychotherapy, participants will be on stable adjunct psychotherapy for at least 8 weeks prior to randomization
• If comorbid diagnosis of attention deficit hyperactivity disorder (ADHD), patients must be on stable dose of stimulants for at least 4 weeks prior to randomization.
• Participants will be able to follow written and verbal instructions in English

You may not qualify if…

• Moderate - severely depressed patients will be excluded at this point due to acceptability concerns (e.g. potential for cybersickness)
• Presence of significant neurological disorders, head trauma, or other unstable medical conditions. These conditions may adversely impact cognitive functioning and influence study results.
• Presence of other psychiatric disorder (e.g. anxiety, psychotic disorder) that may be considered primary.
• Meeting DSM-5 criteria for alcohol or other substance use disorder within three months prior to the randomization visit.*
• Use of benzodiazepine medications more than three times per week and/or within 24 hours of baseline or close out visit
• Use of cannabis or alcohol within 24 hours, or tobacco within 30 minutes of baseline or close out visit
• Suicidal ideation or self harm
• Completion of previous cognitive remediation
• Additionally, patients will be excluded from the study if they meet any of the following criteria due to contraindications with MRI scanning:
• Retained wires from an electronic implant that has been removed (i.e. pacemaker wires not attached to a pacemaker)
• Cardiac pacemaker or defibrillator
• Metal in eye or orbit
• Ferromagnetic aneurysm clip
• Pregnancy
• Makeup tattoos that are not designed to fade over time
• Stainless steel intrauterine device (IUD)
• Depending on the individual situation, they MAY NOT be able to participate if they have/had any of the following:
• Artificial Heart Valve
• Ear or eye implant
• Brain aneurysm clip
• Implanted electronic device (i.e. drug infusion pump, electrical stimulator)
• Coil, catheter, or filter in any blood vessel
• Orthopedic hardware (artificial joint, plate, screw, rod)
• Shrapnel, bullets, or other metal fragments
• Surgery, medical procedure or tattoos (including tattooed eyeliner) in the last six weeks

Where it is running

• UBC Centre for Brain Health — Vancouver, British Columbia, Canada (enrolling)

Full record on ClinicalTrials.gov

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