bWell-D Pilot Randomized Controlled Trial

NCT06546917 | Recruiting

• 1 other identifier: H24-00404_a
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• Change in cognitive functioning in active vs. control groups

  8 weeks

• Change in global psychosocial functioning in active vs. control groups

  8 weeks

• Change in individual cognitive domains in active vs. control groups

  8 weeks

• Change in subjective perceived cognitive functioning in active vs. control groups

  8 weeks

• Measure of video game satisfaction/enjoyability of bWell-D remediation in active vs. control groups

  8 weeks

Study Arms (2)

bWell Cognitive Remediation

ACTIVE COMPARATOR

Patients with Major Depressive Disorder who will complete cognitive remediation sessions using bWell twice a week for eight weeks.

Behavioral: bWell Cognitive Remediation

VR Experience

SHAM COMPARATOR

Patients with Major Depressive Disorder who will experience various VR scenes twice a week for eight weeks.

Behavioral: VR Experience

Interventions

bWell Cognitive Remediation BEHAVIORAL

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.

bWell Cognitive Remediation

VR Experience BEHAVIORAL

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.

VR Experience

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• If using antidepressants, participants will be on stable antidepressant therapy for at least 4 weeks prior to randomization. All concomitant doctor-prescribed medications must be at a stable dose for 4 weeks prior to the randomization visit.
• If undergoing psychotherapy, participants will be on stable adjunct psychotherapy for at least 8 weeks prior to randomization
• If comorbid diagnosis of attention deficit hyperactivity disorder (ADHD), patients must be on stable dose of stimulants for at least 4 weeks prior to randomization.
• Participants will be able to follow written and verbal instructions in English

You may not qualify if:

• 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.\*
• Use of benzodiazepine medications more than three times per week and/or within 24 hours of baseline or close out visit
• Use of cannabis or alcohol within 24 hours, or tobacco within 30 minutes of baseline or close out visit
• Suicidal ideation or self harm
• Completion of previous cognitive remediation
• Additionally, patients will be excluded from the study if they meet any of the following criteria due to contraindications with MRI scanning:
• Retained wires from an electronic implant that has been removed (i.e. pacemaker wires not attached to a pacemaker)
• Cardiac pacemaker or defibrillator
• Metal in eye or orbit
• Ferromagnetic aneurysm clip
• Pregnancy
• Makeup tattoos that are not designed to fade over time

Sponsors & Collaborators

• University of British Columbia: lead
• Simon Fraser University: collaborator
• National Research Council, Canada: collaborator

Study Sites (1)

UBC Centre for Brain Health

Vancouver, British Columbia, V6T 1Z3, Canada

RECRUITING

Related Publications (2)

• Gagnon Shaigetz V, Proulx C, Cabral A, Choudhury N, Hewko M, Kohlenberg E, Segado M, Smith MSD, Debergue P. An Immersive and Interactive Platform for Cognitive Assessment and Rehabilitation (bWell): Design and Iterative Development Process. JMIR Rehabil Assist Technol. 2021 Nov 3;8(4):e26629. doi: 10.2196/26629.

  PMID: 34730536 BACKGROUND

• Hernandez Hernandez ME, Michalak E, Choudhury N, Hewko M, Torres I, Menon M, Lam RW, Chakrabarty T. Co-design of a Virtual Reality Cognitive Remediation Program for Depression (bWell-D) With Patient End Users and Clinicians: Qualitative Interview Study Among Patients and Clinicians. JMIR Serious Games. 2023 Apr 7;11:e43904. doi: 10.2196/43904.

  PMID: 37027183 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Trisha Chakrabarty, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trisha Chakrabarty, MD

CONTACT

6048227512; trisha.chakrabarty@ubc.ca

Faranak Farzan, PhD

CONTACT

7787827571; ffarzan@sfu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients are told that either arm 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 as to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 9, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)