Depressive Disorder, MajorNCT06546917
bWell-D Pilot Randomized Controlled Trial
A study testing bWell Cognitive Remediation and VR Experience in people with Depressive Disorder, Major and Cognitive Dysfunction, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Major, Cognitive Dysfunction
- What is being tested?
- bWell Cognitive Remediation and VR Experience
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2025to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
- 19-55 years old
Who cannot join
- 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
Show all 31Show fewer
- 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:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
UBC Centre for Brain Health
Vancouver, British Columbia, V6T 1Z3
Trisha Chakrabarty, MD
About this study
Official title: The bWell Cognitive Care Platform: A Pilot Feasibility Study in Patients With Depression
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?
Read more
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
Read the detailed description
Patients with a diagnosis of major depressive disorder, who are currently either euthymic or mildly depressed, will be recruited for this study. 40 participants (ages 19-55) will be recruited from the community from two outpatient sites. 20 patients will be recruited at University of British Columbia (UBC) and 20 patients will be recruited at Simon Fraser University (SFU). Patients will complete an initial virtual assessment to assess eligibility, after which patients will complete the bWell cognitive assessment session. This session will include rating scales for current symptoms of depression/anxiety, subjective cognitive functioning, global/occupational functioning and a validated computerized neuropsychological test battery to assess objective cognitive functioning. Participants will complete a brief VR training session with the VR equipment. Subsequently, the bWell cognitive assessment program will be administered, followed by scales assessing tolerability and enjoyability/engagement.
Patients will then be randomized in a 1:1 ratio to receive bWell cognitive remediation or to a control group in which they passively experience various VR scenes. Randomization will occur separately in inpatient and outpatient groups. Patients are told that either method is hypothesized to have effects on their cognition and are therefore blinded to whether they are in the 'active' treatment group. Assessors for outcomes that are not self-reported or self-administered will also be blinded to group assignment. Participants randomized to the bWell cognitive remediation program will complete 40-minute remediation sessions using bWell twice a week for 8 weeks; the other group will view VR scenes in bWell without any instructed cognitive tasks. EEG recordings will be administered at baseline, at midpoint, and after completing the 8 weeks. At the end of the 8 weeks, measures of subjective cognitive functioning, global/occupational functioning and the computerized objective cognitive testing battery will also be repeated. Patients will also undergo 2 MRI scans including a resting state fMRI and a structural MRI; these sessions will be scheduled once at baseline and once in the two following weeks after the last remediation/VR experience session. Patients will also complete tolerability and enjoyment/engagement scales during the remediation procedure. Patients will be debriefed at the end of their participation about their treatment groups. Patients randomized to bWell remediation group will also have the option of participating in a parallel study with the eBrain Lab at Simon Fraser University assessing neurophysiology of different brain regions using transcranial magnetic stimulation combined with electroencephalography (TMS-EEG).
In addition to MDD participants recruited and randomized, we will be recruiting 70 healthy individuals of the same age range (19-55) to complete the assessment session. Following phone screen, they will come in and complete the SCID, bWell-D assessment, session CNS vital signs, and rating scales for current symptoms of depression/anxiety, subjective cognitive functioning, global/occupational functioning and engagement and tolerability scales. This session will take approximately 3 hours, and participants will receive $60 for their participation.
- Conditions
- Depressive Disorder, Major, Cognitive Dysfunction
- Being tested
- bWell Cognitive Remediation, VR Experience
- Medical subject headings
- Depressive Disorder, Major, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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:
- Lab Exercise: participant alternates between two different, increasingly complex 'recipes', targeting executive functioning and divided attention.
- 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.
- Mole Exercise: participants must strike moles with the matching coloured hammer as fast as possible, targeting selective attention.
- Theatre Exercise: participants must remember objects presented on stage and recreate the sequence after the curtains close, targeting working memory.
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.
| Study group | Role | What they receive |
|---|---|---|
| bWell Cognitive Remediation | Active comparator | Patients with Major Depressive Disorder who will complete cognitive remediation sessions using bWell twice a week for eight weeks. Receives: Behavioral: bWell Cognitive Remediation |
| VR Experience | Sham comparator | Patients with Major Depressive Disorder who will experience various VR scenes twice a week for eight weeks. Receives: Behavioral: VR Experience |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
Measured separately in inpatient and outpatient settings, target of 2/month total from both sites. Will be assessed every 6 months and appropriate action taken if target not met.
Measured: 8 weeks
Session completion rates
Measured separately in inpatient and outpatient settings, target of 80% completion of all studies. Will be assessed after the 5th and 10th participants to complete bWell-D assessment and mid-point of bWell-D remediation, with appropriate action taken if not met.
Measured: 8 weeks
Study drop out rates
Measured separately in inpatient and outpatient settings, target 20% or less participant dropouts. Will be assessed after the 5th and 10th participants to complete bWell-D assessment and mid-point of bWell-D remediation, with appropriate action taken if not met.
Measured: 8 weeks
Secondary outcomes (9)
Change in cognitive functioning in active vs. control groups
Assessed using the Neurocognitive Index (NCI) score generated by the Central Nervous System Vital Signs (CNS-VS), an index of global cognitive functioning
Measured: 8 weeks
Change in global psychosocial functioning in active vs. control groups
Assessed through self-report using the Sheehan Disability Scale (SDS) and Quality of Life Enjoyment and Satisfaction Questionnaire. When self-reporting scores on the SDS, patients are asked to rank on a 10-point scale the level of disruption they have experienced at work/school, in their social life and home responsibilities over the past week. Total scores range from a minimum of 0 to a maximum of 30, where higher scores represent increased functional impairment.
Measured: 8 weeks
Change in individual cognitive domains in active vs. control groups
Assessed via the individual domain scores generated by the CNS-VS computerized battery
Measured: 8 weeks
Change in subjective perceived cognitive functioning in active vs. control groups
Assessed via the Perceived Deficits Questionnaire for Depression (PDQ-D), a self-report scale assessing patients' perceived functioning in four domains: attention/concentration, planning/organization, retrospective memory and prospective memory. Total score ranges from 0 to 80, where higher scores represent increased cognitive impairment.
Measured: 8 weeks
Measure of video game satisfaction/enjoyability of bWell-D remediation in active vs. control groups
Assessed using the The Game User Experience Satisfaction Scale-18 (GUESS-18). Total score ranges from a minimum value of 9 to a maximum value of 63, where higher scores represent increased satisfaction.
Measured: 8 weeks
Change in occupational psychosocial functioning in active vs. control groups
Assessed through self-report using the Lam Employment Absence and Productivity Scale (LEAPS). When self-reporting on LEAPS, patients rate the degree to which problems with low energy/motivation, anxiety/irritability, poor concentration, decreased productivity/mistakes and interpersonal problems have impacted their occupational performance over the past 2 weeks. Total scores range from a minimum of 0 to a maximum of 28, where higher total scores represent increasingly impaired professional functioning.
Measured: 8 weeks
Change in subjective everyday cognitive functioning in active vs. control groups
Assessed via the Cognitive Failures Questionnaire (CFQ), which assesses lapses of attention, perception and memory in real-life. Total score ranges from a minimum of 0 to a maximum of 100, where higher scores represent increased everyday cognitive failures.
Measured: 8 weeks
Measure of engagement with bWell-D remediation in active vs. control groups
Assessed using the User Engagement Scale (UES). There is a minimum score of 0 and a maximum score of 235.62, where higher scores represent increased engagement.
Measured: 8 weeks
Measure of tolerability of bWell-D remediation in active vs. control groups
Assessed using Simulator Sickness Questionnaire (SSQ). Patients rate the presence and severity of various symptoms of cybersickness, including nausea and ocular discomfort. There is a minimum score of 4 and a maximum score of 20, where higher scores represent increased simulator sickness.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jan 2025
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Simon Fraser University, National Research Council Canada
- Responsible party
- Principal investigator, Trisha Chakrabarty, University of British Columbia
- Investigators
- Trisha Chakrabarty, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546917
- Sponsor's protocol ID
- H24-00404_a
- Status last verified
- Apr 2026
- First submitted
- 23 Jul 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gagnon Shaigetz V, Proulx C, Cabral A, Choudhury N, Hewko M, Kohlenberg E, Segado M, Smith MSD, Debergue P. An Immersive and Interactive Platform for Cognitive Assessment and Rehabilitation (bWell): Design and Iterative Development Process. JMIR Rehabil Assist Technol. 2021 Nov 3;8(4):e26629. doi: 10.2196/26629.
PubMed 34730536Hernandez Hernandez ME, Michalak E, Choudhury N, Hewko M, Torres I, Menon M, Lam RW, Chakrabarty T. Co-design of a Virtual Reality Cognitive Remediation Program for Depression (bWell-D) With Patient End Users and Clinicians: Qualitative Interview Study Among Patients and Clinicians. JMIR Serious Games. 2023 Apr 7;11:e43904. doi: 10.2196/43904.
PubMed 37027183
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The bWell Cognitive Care Platform: A Pilot Feasibility Study in Patients With Depression
- ClinicalTrials.gov ID
- NCT06546917
- Acronym / sponsor ID
- H24-00404_a
- Conditions
- Depressive Disorder, Major, Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Simon Fraser University, National Research Council Canada
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Patients with a diagnosis of major depressive disorder, who are currently either euthymic or mildly depressed, will be recruited for this study. 40 participants (ages 19-55) will be recruited from the community from two outpatient sites. 20 patients will be recruited at University of British Columbia (UBC) and 20 patients will be recruited at Simon Fraser University (SFU). Patients will complete an initial virtual assessment to assess eligibility, after which patients will complete the bWell cognitive assessment session. This session will include rating scales for current symptoms of depression/anxiety, subjective cognitive functioning, global/occupational functioning and a validated computerized neuropsychological test battery to assess objective cognitive functioning. Participants will complete a brief VR training session with the VR equipment. Subsequently, the bWell cognitive assessment program will be administered, followed by scales assessing tolerability and enjoyability/engagement.
Patients will then be randomized in a 1:1 ratio to receive bWell cognitive remediation or to a control group in which they passively experience various VR scenes. Randomization will occur separately in inpatient and outpatient groups. Patients are told that either method is hypothesized to have effects on their cognition and are therefore blinded to whether they are in the 'active' treatment group. Assessors for outcomes that are not self-reported or self-administered will also be blinded to group assignment. Participants randomized to the bWell cognitive remediation program will complete 40-minute remediation sessions using bWell twice a week for 8 weeks; the other group will view VR scenes in bWell without any instructed cognitive tasks. EEG recordings will be administered at baseline, at midpoint, and after completing the 8 weeks. At the end of the 8 weeks, measures of subjective cognitive functioning, global/occupational functioning and the computerized objective cognitive testing battery will also be repeated. Patients will also undergo 2 MRI scans including a resting state fMRI and a structural MRI; these sessions will be scheduled once at baseline and once in the two following weeks after the last remediation/VR experience session. Patients will also complete tolerability and enjoyment/engagement scales during the remediation procedure. Patients will be debriefed at the end of their participation about their treatment groups. Patients randomized to bWell remediation group will also have the option of participating in a parallel study with the eBrain Lab at Simon Fraser University assessing neurophysiology of different brain regions using transcranial magnetic stimulation combined with electroencephalography (TMS-EEG).
In addition to MDD participants recruited and randomized, we will be recruiting 70 healthy individuals of the same age range (19-55) to complete the assessment session. Following phone screen, they will come in and complete the SCID, bWell-D assessment, session CNS vital signs, and rating scales for current symptoms of depression/anxiety, subjective cognitive functioning, global/occupational functioning and engagement and tolerability scales. This session will take approximately 3 hours, and participants will receive $60 for their participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bWell Cognitive Remediation | Active comparator | Behavioral: bWell Cognitive RemediationPatients with Major Depressive Disorder who will complete cognitive remediation sessions using bWell twice a week for eight weeks. |
| VR Experience | Sham comparator | Behavioral: VR ExperiencePatients with Major Depressive Disorder who will experience various VR scenes twice a week for eight weeks. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bWell Cognitive RemediationPatients 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. | Behavioural | bWell Cognitive Remediation |
| VR ExperiencePatients 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. | Behavioural | VR Experience |
Primary outcome
Recruitment rates
Time frame: 8 weeks
Measured separately in inpatient and outpatient settings, target of 2/month total from both sites. Will be assessed every 6 months and appropriate action taken if target not met.
Session completion rates
Time frame: 8 weeks
Measured separately in inpatient and outpatient settings, target of 80% completion of all studies. Will be assessed after the 5th and 10th participants to complete bWell-D assessment and mid-point of bWell-D remediation, with appropriate action taken if not met.
Study drop out rates
Time frame: 8 weeks
Measured separately in inpatient and outpatient settings, target 20% or less participant dropouts. Will be assessed after the 5th and 10th participants to complete bWell-D assessment and mid-point of bWell-D remediation, with appropriate action taken if not met.
9 secondary outcomes
Change in cognitive functioning in active vs. control groups
Time frame: 8 weeks
Change in global psychosocial functioning in active vs. control groups
Time frame: 8 weeks
Change in individual cognitive domains in active vs. control groups
Time frame: 8 weeks
Change in subjective perceived cognitive functioning in active vs. control groups
Time frame: 8 weeks
Measure of video game satisfaction/enjoyability of bWell-D remediation in active vs. control groups
Time frame: 8 weeks
Change in occupational psychosocial functioning in active vs. control groups
Time frame: 8 weeks
Change in subjective everyday cognitive functioning in active vs. control groups
Time frame: 8 weeks
Measure of engagement with bWell-D remediation in active vs. control groups
Time frame: 8 weeks
Measure of tolerability of bWell-D remediation in active vs. control groups
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 34730536Gagnon Shaigetz V, Proulx C, Cabral A, Choudhury N, Hewko M, Kohlenberg E, Segado M, Smith MSD, Debergue P. An Immersive and Interactive Platform for Cognitive Assessment and Rehabilitation (bWell): Design and Iterative Development Process. JMIR Rehabil Assist Technol. 2021 Nov 3;8(4):e26629. doi: 10.2196/26629.
- Background: PubMed 37027183Hernandez Hernandez ME, Michalak E, Choudhury N, Hewko M, Torres I, Menon M, Lam RW, Chakrabarty T. Co-design of a Virtual Reality Cognitive Remediation Program for Depression (bWell-D) With Patient End Users and Clinicians: Qualitative Interview Study Among Patients and Clinicians. JMIR Serious Games. 2023 Apr 7;11:e43904. doi: 10.2196/43904.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trisha Chakrabarty, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bWell Cognitive Remediation and VR Experience in people with Depressive Disorder, Major and Cognitive Dysfunction, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trisha Chakrabarty, MD (6048227512, trisha.chakrabarty@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06546917, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.