Testing bWell Cognitive Remediation with VR Experience against a placebo for major depressive disorder
Official title: bWell-D Pilot Randomized Controlled Trial
The bWell Cognitive Care Platform: A Pilot Feasibility Study in Patients With Depression
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.
Canadian Sites (1)
UBC Centre for Brain Health
Vancouver, British Columbia, Canada
Eligibility Criteria
See who this study is looking for41 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 baselineBaselineYour starting measurements, taken before treatment begins.Read more →, as indicated by a total Perceived Deficits Questionnaire - Depression 20 \[PDQ-D-20\] score \> 20 at study enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
- +If using antidepressants, participants will be on stable antidepressant therapy for at least 4 weeks prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →. 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
- −\- 19-55 years old
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → visit.\*
- −Use of benzodiazepine medications more than three times per week and/or within 24 hours of baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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
- −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
- −Other metallic prostheses
- −If the participant has any of the above, or any safety issues arise during MRI screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 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 criteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more → is as follows:
- −Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → for healthy controlsControl groupThe group a new treatment is measured against.Read more →:
- −Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → 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 armArmOne of the groups in a study, each receiving something different.Read more → or neck movement
- −Surgery, medical procedure or tattoos (including tattooed eyeliner) in the last six weeks
- −Use of cannabis or alcohol within 24 hours, or tobacco within 30 minutes of baseline or close out visit
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: bWell Cognitive Remediation, VR Experience.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a sham procedureSham procedureA procedure made to feel like the real one, without the active step.Read more → — one made to feel like the real thing but without the active step.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 19 years to 55 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 40 people.
The study is currently expected to finish around August 2026.
The main measurement is taken over: 8 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Recruitment rates — measured over 8 weeks.
Session completion rates — measured over 8 weeks.
Study drop out rates — measured over 8 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06546917 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About bWell Cognitive RemediationBehavioural
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.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About VR ExperienceBehavioural
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.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 19 years to 55 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study includes a shamSham procedureA procedure made to feel like the real one, without the active step.Read more → comparison — a procedure made to feel like the real one, without the active step.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 19 years to 55 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 8 weeks.
The study as a whole is currently expected to finish around 2026-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 40 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Vancouver, British Columbia, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.