NCT06546917

bWell-D Pilot Randomized Controlled Trial

The bWell Cognitive Care Platform: A Pilot Feasibility Study in Patients With Depression

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Not accepted

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

Detailed description

Patients with a diagnosis of major depressive disorder, who are currently either euthymic or mildly depressed, will be recruited for this study. 40 participants (ages 19-55) will be recruited from the community from two outpatient sites and 30 participants will be recruited from an inpatient site. For the outpatient sample, 20 patients will be recruited at University of British Columbia (UBC) and 20 patients will be recruited at Simon Fraser University (SFU), and for the inpatient sample, 30 patients will be recruited in collaboration with the John Volken Academy (JVA). Patients will complete an initial virtual assessment to assess eligibility, after which patients will complete the bWell cognitive assessment session. This session will include rating scales for current symptoms of depression/anxiety, subjective cognitive functioning, global/occupational functioning and a validated computerized neuropsychological test battery to assess objective cognitive functioning. Participants will complete a brief VR training session with the VR equipment. Subsequently, the bWell cognitive assessment program will be administered, followed by scales assessing tolerability and enjoyability/engagement. Patients will then be randomized in a 1:1 ratio to receive bWell cognitive remediation or to a control group in which they passively experience various VR scenes. Randomization will occur separately in inpatient and outpatient groups. Patients are told that either method is hypothesized to have effects on their cognition and are therefore blinded to whether they are in the 'active' treatment group. Assessors for outcomes that are not self-reported or self-administered will also be blinded to group assignment. Participants randomized to the bWell cognitive remediation program will complete 40-minute remediation sessions using bWell twice a week for 8 weeks; the other group will view VR scenes in bWell without any instructed cognitive tasks. EEG recordings will be administered at baseline, at midpoint, and after completing the 8 weeks. At the end of the 8 weeks, measures of subjective cognitive functioning, global/occupational functioning and the computerized objective cognitive testing battery will also be repeated. Patients will also complete tolerability and enjoyment/engagement scales during the remediation procedure. Patients will be debriefed at the end of their participation about their treatment groups.

Conditions

• Depressive Disorder, Major
• Cognitive Dysfunction

Interventions

Type	Name	Description
BEHAVIORAL	bWell Cognitive Remediation	Patients 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.
BEHAVIORAL	VR Experience	Patients 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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2024-08-09
• Last updated: 2024-08-09