Phase
Condition
Dementia
Memory Loss
Mental Disability
Treatment
bWell Cognitive Remediation
VR Experience
Clinical Study ID
Ages 19-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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-AsbergDepression Rating Scale [MADRS] score < 19)
Patients will report subjective cognitive deficits at baseline, as indicated by atotal Perceived Deficits Questionnaire - Depression 20 [PDQ-D-20] score > 20 atstudy enrollment.
If using antidepressants, participants will be on stable antidepressant therapy forat least 4 weeks prior to randomization. All concomitant doctor-prescribedmedications must be at a stable dose for 4 weeks prior to the randomization visit.
If undergoing psychotherapy, participants will be on stable adjunct psychotherapyfor at least 8 weeks prior to randomization
If comorbid diagnosis of attention deficit hyperactivity disorder (ADHD), patientsmust 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
Exclusion Criteria:
Moderate - severely depressed patients will be excluded at this point due toacceptability concerns (e.g. potential for cybersickness)
Presence of significant neurological disorders, head trauma, or other unstablemedical conditions. These conditions may adversely impact cognitive functioning andinfluence study results.
Presence of other psychiatric disorder (e.g. anxiety, psychotic disorder) that maybe considered primary.
Meeting DSM-5 criteria for alcohol or other substance use disorder within threemonths prior to the randomization visit.*
Use of benzodiazepine medications more than three times per week and/or within 24hours of baseline or close out visit
Use of cannabis or alcohol within 24 hours, or tobacco within 30 minutes of baselineor 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. pacemakerwires 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 sixweeks
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 psychiatricdiagnostic interview
Presence of significant neurological disorder, head trauma, or other unstablemedical conditions which may adversely impact cognitive functioning
Presence of any physical mobility issues that limit arm or neck movement
Study Design
Study Description
Connect with a study center
UBC Centre for Brain Health
Vancouver, British Columbia V6T 1Z3
CanadaActive - Recruiting

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