Status:
NOT_YET_RECRUITING
bWell-D Pilot Randomized Controlled Trial
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Simon Fraser University
National Research Council, Canada
Conditions:
Depressive Disorder, Major
Cognitive Dysfunction
Eligibility:
All Genders
19-55 years
Phase:
NA
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 asses...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06546917
Start Date
August 1 2024
End Date
August 1 2026
Last Update
August 9 2024
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