bWell-D Pilot Randomized Controlled Trial
NCT Number: NCT06546917
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depressive Disorder, Major|Cognitive Dysfunction
Interventions: BEHAVIORAL: bWell Cognitive Remediation|BEHAVIORAL: VR Experience
Sponsor: University of British Columbia
Collaborators: Simon Fraser University|National Research Council, Canada
Sex: ALL
Age: ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2026-08

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 measures of tolerability, engagement, and enjoyment

Primary Outcome Measures: 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., 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., 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., 8 weeks
Secondary Outcome Measures: 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, 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., 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, 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., 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., 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., 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., 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., 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., 8 weeks