No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 – 55
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
University of British Columbia · Other
Who this trial is looking for
This trial is looking for adults with Major Depressive Disorder who want to try a new virtual reality tool to improve their cognitive function. Participants will complete an initial assessment and, if accepted, engage in sessions twice a week for eight weeks.
Are You a Good Fit for This Trial?
Must be takingAntidepressants
You may be able to join if
I am between 19 and 55 years old.
I have been diagnosed with Major Depressive Disorder.
I am mildly depressed or stable.
I report cognitive difficulties.
I have been on stable antidepressant therapy for at least 4 weeks.
I can follow instructions in English.
You may not be able to join if
I am moderately to severely depressed.
I have significant neurological disorders.
I have another psychiatric disorder.
I have had substance use issues in the last three months.
I use benzodiazepines frequently.
I have suicidal thoughts.
I have completed cognitive remediation before.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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, t…
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
Trial Locations
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Eligibility 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 (define…
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
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