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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
bWell Cognitive Remediation
BehavioralPatients 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.
VR Experience
BehavioralPatients 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: bWell Cognitive RemediationActive comparator 1 intervention
Group B: VR ExperienceSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
8 weeks2
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.
Time frame
8 weeks3
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.
Time frame
8 weeksSecondary outcomes
1
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
Time frame
8 weeks2
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.
Time frame
8 weeks3
Change in individual cognitive domains in active vs. control groups
Assessed via the individual domain scores generated by the CNS-VS computerized battery
Time frame
8 weeks4
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.
Time frame
8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
Simon Fraser University
Collaborator
National Research Council, Canada
Collaborator
Source ClinicalTrials.gov