BridgeMD
New treatment option for Depressive Disorder, Major
Official title bWell-D Pilot Randomized Controlled Trial
ClinicalTrials.gov ID: NCT06546917
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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]...
- If using antidepressants, participants will be on stable antidepressant therapy for at least 4 weeks prior to randomization. All concomitant...
You likely can't join if
- 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...
- 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
See the full eligibility 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.