Pilot test of the bWell‑D VR cognitive program for adults with major depression
The bWell Cognitive Care Platform: A Pilot Feasibility Study in Patients With Depression
This pilot will test whether a VR cognitive assessment and an eight‑week VR cognitive training program (bWell‑D) are acceptable and doable for adults with major depressive disorder who report cognitive problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 19 Years to 55 Years |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06546917 on ClinicalTrials.gov |
What this trial studies
Researchers will recruit 40 adults (ages 19–55) with DSM‑5 major depressive disorder and subjective cognitive complaints from two Vancouver‑area outpatient sites. Participants complete an initial virtual eligibility assessment and a bWell cognitive assessment session with symptom and cognitive measures, then are randomized 1:1 to eight weeks of twice‑weekly bWell cognitive remediation or a control VR scenes experience. Sessions include a brief VR training, the intervention or control exposure, and tolerability/engagement ratings; outcome assessors for non‑self‑reported measures are blinded. The trial focuses on feasibility, tolerability, acceptability, and the preliminary validity of the bWell assessment and remediation protocol rather than definitive efficacy.
Who should consider this trial
Good fit: Adults aged 19–55 with DSM‑5 major depressive disorder who are euthymic or mildly depressed (MADRS < 19), report cognitive difficulties (PDQ‑D‑20 > 20), and are on stable medication and psychotherapy regimens are ideal candidates.
Not a fit: Patients with moderate‑to‑severe depression, unstable medications or therapy, significant comorbidities that affect cognition, or inability/unwillingness to use VR equipment are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, bWell‑D could offer a convenient VR‑based option to identify and improve cognitive symptoms that interfere with daily functioning in people with depression.
How similar studies have performed: Some small trials of digital cognitive training and early VR interventions show promise for cognitive symptoms in depression, but VR‑based remediation in MDD remains an emerging and not yet well‑established approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Other metallic prostheses If the participant has any of the above, or any safety issues arise during MRI screening process, the individual case will be reviewed by UBC Hospital MR Technologist and/or Radiologist and a case-by-case decision will be made regarding participation. Additionally, for the healthy participant recruitment, the eligibility criteria is as follows: Inclusion Criteria for healthy controls: \- 19-55 years old Exclusion criteria for healthy controls: * History of any psychiatric disorder, as assessed by a standardized psychiatric diagnostic interview * Presence of significant neurological disorder, head trauma, or other unstable medical conditions which may adversely impact cognitive functioning * Presence of any physical mobility issues that limit arm or neck movement
Where this trial is running
Vancouver, British Columbia
- UBC Centre for Brain Health — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Trisha Chakrabarty, MD — University of British Columbia
- Study coordinator: Trisha Chakrabarty, MD
- Email: trisha.chakrabarty@ubc.ca
- Phone: 6048227512
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.