Clinical trial NCT06546917: bWell-D Pilot Randomized Controlled Trial
Official title: The bWell Cognitive Care Platform: A Pilot Feasibility Study in Patients With Depression
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depressive Disorder, Major
Cognitive Dysfunction
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Simon Fraser University
name: National Research Council, Canada
First posted: 2024-08-09
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

  * 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.

Primary outcomes:
measure: Recruitment rates
timeFrame: 8 weeks
measure: Session completion rates
timeFrame: 8 weeks
measure: Study drop out rates
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in cognitive functioning in active vs. control groups
timeFrame: 8 weeks
measure: Change in global psychosocial functioning in active vs. control groups
timeFrame: 8 weeks
measure: Change in individual cognitive domains in active vs. control groups
timeFrame: 8 weeks
measure: Change in subjective perceived cognitive functioning in active vs. control groups
timeFrame: 8 weeks
measure: Measure of video game satisfaction/enjoyability of bWell-D remediation in active vs. control groups
timeFrame: 8 weeks
measure: Change in occupational psychosocial functioning in active vs. control groups
timeFrame: 8 weeks
measure: Change in subjective everyday cognitive functioning in active vs. control groups
timeFrame: 8 weeks
measure: Measure of engagement with bWell-D remediation in active vs. control groups
timeFrame: 8 weeks
measure: Measure of tolerability of bWell-D remediation in active vs. control groups
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Trisha Chakrabarty, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.