bWell-D Pilot Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-55
SponsorUniversity of British Columbia
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.*
Trial design
Treatments tested in this trial
- bWell Cognitive Remediation
- VR Experience
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of British Columbia
Lead sponsor
Simon Fraser University
Collaborator
National Research Council, Canada
Collaborator
Source ClinicalTrials.gov