bWell-D Pilot Randomized Controlled Trial

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 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

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
• 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:
• Inclusion Criteria for healthy controls:
• \- 19-55 years old
• Exclusion criteria for healthy controls:
• 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