bWell-D Pilot Randomized Controlled Trial

NCT ID: NCT06546917

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-31
• Study Completion Date: 2026-08-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

bWell Cognitive Remediation

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

Group Type: ACTIVE_COMPARATOR

bWell Cognitive Remediation

Intervention Type: 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.

VR Experience

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

Group Type: SHAM_COMPARATOR

VR Experience

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.
• If participants are on antidepressant therapy, participants will be on stable antidepressant therapy for at least 8 weeks prior to randomization. All concomitant doctor-prescribed medications must be at a stable dose for 4 weeks prior to the randomization visit.
• If participants are on psychotherapy, participants will be on stable adjunct psychotherapy for at least 12 weeks prior to randomization
• If comorbid diagnosis of attention deficit hyperactivity disorder (ADHD), patients must be on stable dose of stimulants for at least 8 weeks prior to randomization.
• Participants will be able to follow written and verbal instructions in English

Exclusion Criteria

• 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Simon Fraser University

OTHER

Sponsor Role: collaborator

National Research Council, Canada

UNKNOWN

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Trisha Chakrabarty

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trisha Chakrabarty, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Central Contacts

Trisha Chakrabarty, MD

Role: CONTACT

trisha.chakrabarty@ubc.ca

6048227512

Faranak Farzan, PhD

Role: CONTACT

ffarzan@sfu.ca

7787827571

References

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.

Reference Type: BACKGROUND

PMID: 34730536 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37027183 (View on PubMed)

Other Identifiers

H24-00404

Identifier Type: -

Identifier Source: org_study_id