Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546917
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
bWell-D Pilot Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The bWell Cognitive Care Platform A Pilot Feasibility Study in Patients With Depression
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 cognitivefunctionalclinical assessments and EEG at baseline midpoint and endpoint of the remediation protocol as well as measures of tolerability engagement and enjoyment
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 cognitivefunctionalclinical assessments and EEG at baseline midpoint and endpoint of the remediation protocol as well as measures of tolerability engagement and enjoyment
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 community from two outpatient sites and 30 participants will be recruited from an inpatient site For the outpatient sample 20 patients will be recruited at University of British Columbia UBC and 20 patients will be recruited at Simon Fraser University SFU and for the inpatient sample 30 patients will be recruited in collaboration with the John Volken Academy JVA Patients will complete an initial virtual assessment to assess eligibility after which patients will complete the bWell cognitive assessment session This session will include rating scales for current symptoms of depressionanxiety subjective cognitive functioning globaloccupational functioning and a validated computerized neuropsychological test battery to assess objective cognitive functioning Participants will complete a brief VR training session with the VR equipment Subsequently the bWell cognitive assessment program will be administered followed by scales assessing tolerability and enjoyabilityengagement
Patients will then be randomized in a 11 ratio to receive bWell cognitive remediation or to a control group in which they passively experience various VR scenes Randomization will occur separately in inpatient and outpatient groups Patients are told that either method is hypothesized to have effects on their cognition and are therefore blinded to whether they are in the active treatment group Assessors for outcomes that are not self-reported or self-administered will also be blinded to group assignment Participants randomized to the bWell cognitive remediation program will complete 40-minute remediation sessions using bWell twice a week for 8 weeks the other group will view VR scenes in bWell without any instructed cognitive tasks EEG recordings will be administered at baseline at midpoint and after completing the 8 weeks At the end of the 8 weeks measures of subjective cognitive functioning globaloccupational functioning and the computerized objective cognitive testing battery will also be repeated Patients will also complete tolerability and enjoymentengagement scales during the remediation procedure Patients will be debriefed at the end of their participation about their treatment groups
Patients will then be randomized in a 11 ratio to receive bWell cognitive remediation or to a control group in which they passively experience various VR scenes Randomization will occur separately in inpatient and outpatient groups Patients are told that either method is hypothesized to have effects on their cognition and are therefore blinded to whether they are in the active treatment group Assessors for outcomes that are not self-reported or self-administered will also be blinded to group assignment Participants randomized to the bWell cognitive remediation program will complete 40-minute remediation sessions using bWell twice a week for 8 weeks the other group will view VR scenes in bWell without any instructed cognitive tasks EEG recordings will be administered at baseline at midpoint and after completing the 8 weeks At the end of the 8 weeks measures of subjective cognitive functioning globaloccupational functioning and the computerized objective cognitive testing battery will also be repeated Patients will also complete tolerability and enjoymentengagement scales during the remediation procedure Patients will be debriefed at the end of their participation about their treatment groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None