Recruiting

bWell-D

Sponsor:

University of British Columbia

Code:

NCT06546917

Conditions

Depressive Disorder, Major

Cognitive Dysfunction

Eligibility Criteria

Sex: All

Age: 19 - 55

Healthy Volunteers: Accepted

Interventions

bWell Cognitive Remediation

VR Experience

Study Details

Brief summary:

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

Depressive Disorder, Major

Cognitive Dysfunction

Study ID

NCT06546917

Start date

Jan 1, 2025

Status verified date

Apr, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: bWell Cognitive Remediation

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

sham comparator: VR Experience

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

Interventions

bWell Cognitive Remediation

Patients will take part in the bWell cognitive remediation protocol, consisting of 40-minute sessions of bWell, administered 2 times a week for 8 weeks. These sessions consist of tasks that target various cognitive domains and increase in complexity and difficulty as training progresses. The tasks are as follows:

1. Lab Exercise: participant alternates between two different, increasingly complex 'recipes', targeting executive functioning and divided attention.
2. Egg Exercise: In an office environment, participants must seek out and maintain their gaze on certain objects in order to collect them in the presence of visual distractors, targeting sustained attention.
3. Mole Exercise: participants must strike moles with the matching coloured hammer as fast as possible, targeting selective attention.
4. Theatre Exercise: participants must remember objects presented on stage and recreate the sequence after the curtains close, targeting working memory.

VR Experience

Patients will take part in the viewing of VR scenes which contain no instructed cognitive tasks. This consists of 40-minute sessions of viewing VR scenes, administered 2 times a week for 8 weeks.

Primary outcome measure

  • Recruitment rates [ Time Frame: 8 weeks ]
  • Session completion rates [ Time Frame: 8 weeks ]
  • Study drop out rates [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Faranak Farzan, PhD

7787827571ffarzan@sfu.ca

Locations

UBC Centre for Brain Health

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z3

More Information

Sponsor

University of British Columbia

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-04-28.