bWell-D Pilot Randomized Controlled Trial

University of British Columbia

Status: Not yet enrolling

Conditions: Cognitive Dysfunction; Depressive Disorder, Major

Treatments: Behavioral: bWell Cognitive Remediation; Behavioral: VR Experience

Study type: Interventional

Funder types: Other

Identifiers

NCT06546917

H24-00404

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 19 to 55 years old

Volunteers: No Healthy Volunteers

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

  • Patients recruited from the inpatient settings at the John Volken Academy, have a slightly different exclusion criteria for substance use disorders and only will be excluded if they meet DSM-5 criteria for alcohol or other substance use disorder within one month prior to the randomization visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

bWell Cognitive Remediation

Active Comparator group

Description:

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

Treatment:

Behavioral: bWell Cognitive Remediation

VR Experience

Sham Comparator group

Description:

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

Treatment:

Behavioral: VR Experience