RecruitingNot ApplicableNCT06546917

bWell-D Pilot Randomized Controlled Trial

The bWell Cognitive Care Platform: A Pilot Feasibility Study in Patients With Depression

Sponsor

University of British Columbia

Enrollment

40 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Cognitive Dysfunction Depressive Disorder, Major

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

Eligibility

Min Age: 19 YearsMax Age: 55 Years

Inclusion Criteria9

-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 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
\- 19-55 years old

Exclusion Criteria31

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
Stainless steel intrauterine device (IUD)
Depending on the individual situation, they MAY NOT be able to participate if they have/had any of the following:
Artificial Heart Valve
Ear or eye implant
Brain aneurysm clip
Implanted electronic device (i.e. drug infusion pump, electrical stimulator)
Coil, catheter, or filter in any blood vessel
Orthopedic hardware (artificial joint, plate, screw, rod)
Shrapnel, bullets, or other metal fragments
Surgery, medical procedure or tattoos (including tattooed eyeliner) in the last six weeks
Other metallic prostheses
If the participant has any of the above, or any safety issues arise during MRI screening process, the individual case will be reviewed by UBC Hospital MR Technologist and/or Radiologist and a case-by-case decision will be made regarding participation.
Additionally, for the healthy participant recruitment, the eligibility criteria is as follows:
History of any psychiatric disorder, as assessed by a standardized psychiatric diagnostic interview
Presence of significant neurological disorder, head trauma, or other unstable medical conditions which may adversely impact cognitive functioning
Presence of any physical mobility issues that limit arm or neck movement

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Interventions

BEHAVIORALbWell 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.

BEHAVIORALVR 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.