bWell-D Pilot Randomized Controlled Trial

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

Conditions

• Depressive Disorder, Major
• Cognitive Dysfunction

Interventions

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.

Sponsors & Collaborators

• Simon Fraser University

  collaborator OTHER

• National Research Council, Canada

  collaborator UNKNOWN

• University of British Columbia

  lead OTHER

Principal Investigators

• Trisha Chakrabarty, MD · University of British Columbia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• Canada

Study Locations