bWell-D Pilot Randomized Controlled Trial (NCT06546917) | Clinical Trial Compass
RecruitingNot Applicable
bWell-D Pilot Randomized Controlled Trial
Canada40 participantsStarted 2025-01-01
Plain-language 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
Who can participate
Age range19 Years – 55 Years
SexALL
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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…