Cognitive Dysfunction, Depressive Disorder, Major
Conditions
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 cognitive/functional/clinical assessments and EEG at baseline, midpoint and endpoint of the remediation protocol, as well as two MRI scans and 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. 20 patients will be recruited at University of British Columbia (UBC) and 20 patients will be recruited at Simon Fraser University (SFU). 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 depression/anxiety, subjective cognitive functioning, global/occupational 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 enjoyability/engagement. Patients will then be randomized in a 1:1 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, global/occupational functioning and the computerized objective cognitive testing battery will also be repeated. Patients will also undergo 2 MRI scans including a resting state fMRI and a structural MRI; these sessions will be scheduled once at baseline and once in the two following weeks after the last remediation/VR experience session. Patients will also complete tolerability and enjoyment/engagement scales during the remediation procedure. Patients will be debriefed at the end of their participation about their treatment groups. Patients randomized to bWell remediation group will also have the option of participating in a parallel study with the eBrain Lab at Simon Fraser University assessing neurophysiology of different brain regions using transcranial magnetic stimulation combined with electroencephalography (TMS-EEG). In addition to MDD participants recruited and randomized, we will be recruiting 70 healthy individuals of the same age range (19-55) to complete the assessment session. Following phone screen, they will come in and complete the SCID, bWell-D assessment, session CNS vital signs, and rating scales for current symptoms of depression/anxiety, subjective cognitive functioning, global/occupational functioning and engagement and tolerability scales. This session will take approximately 3 hours, and participants will receive $60 for their participation.
Interventions
BEHAVIORALbWell Cognitive Remediation
Patients will take part in the bWell cognitive remediation protocol, consisting of 40-minute sessions of bWell, administered 2 times a week for 8 weeks. These sessions consist of tasks that target various cognitive domains and increase in complexity and difficulty as training progresses. The tasks are as follows: 1. Lab Exercise: participant alternates between two different, increasingly complex 'recipes', targeting executive functioning and divided attention. 2. Egg Exercise: In an office environment, participants must seek out and maintain their gaze on certain objects in order to collect them in the presence of visual distractors, targeting sustained attention. 3. Mole Exercise: participants must strike moles with the matching coloured hammer as fast as possible, targeting selective attention. 4. Theatre Exercise: participants must remember objects presented on stage and recreate the sequence after the curtains close, targeting working memory.
BEHAVIORALVR Experience
Patients will take part in the viewing of VR scenes which contain no instructed cognitive tasks. This consists of 40-minute sessions of viewing VR scenes, administered 2 times a week for 8 weeks.
Sponsors
University of British Columbia
Simon Fraser University
National Research Council, Canada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients are told that either arm 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 as to group allocation.
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rates | 8 weeks | Measured separately in inpatient and outpatient settings, target of 2/month total from both sites. Will be assessed every 6 months and appropriate action taken if target not met. |
| Session completion rates | 8 weeks | Measured separately in inpatient and outpatient settings, target of 80% completion of all studies. Will be assessed after the 5th and 10th participants to complete bWell-D assessment and mid-point of bWell-D remediation, with appropriate action taken if not met. |
| Study drop out rates | 8 weeks | Measured separately in inpatient and outpatient settings, target 20% or less participant dropouts. Will be assessed after the 5th and 10th participants to complete bWell-D assessment and mid-point of bWell-D remediation, with appropriate action taken if not met. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive functioning in active vs. control groups | 8 weeks | Assessed using the Neurocognitive Index (NCI) score generated by the Central Nervous System Vital Signs (CNS-VS), an index of global cognitive functioning |
| Change in global psychosocial functioning in active vs. control groups | 8 weeks | Assessed through self-report using the Sheehan Disability Scale (SDS) and Quality of Life Enjoyment and Satisfaction Questionnaire. When self-reporting scores on the SDS, patients are asked to rank on a 10-point scale the level of disruption they have experienced at work/school, in their social life and home responsibilities over the past week. Total scores range from a minimum of 0 to a maximum of 30, where higher scores represent increased functional impairment. |
| Change in individual cognitive domains in active vs. control groups | 8 weeks | Assessed via the individual domain scores generated by the CNS-VS computerized battery |
| Change in subjective perceived cognitive functioning in active vs. control groups | 8 weeks | Assessed via the Perceived Deficits Questionnaire for Depression (PDQ-D), a self-report scale assessing patients' perceived functioning in four domains: attention/concentration, planning/organization, retrospective memory and prospective memory. Total score ranges from 0 to 80, where higher scores represent increased cognitive impairment. |
| Measure of video game satisfaction/enjoyability of bWell-D remediation in active vs. control groups | 8 weeks | Assessed using the The Game User Experience Satisfaction Scale-18 (GUESS-18). Total score ranges from a minimum value of 9 to a maximum value of 63, where higher scores represent increased satisfaction. |
| Change in occupational psychosocial functioning in active vs. control groups | 8 weeks | Assessed through self-report using the Lam Employment Absence and Productivity Scale (LEAPS). When self-reporting on LEAPS, patients rate the degree to which problems with low energy/motivation, anxiety/irritability, poor concentration, decreased productivity/mistakes and interpersonal problems have impacted their occupational performance over the past 2 weeks. Total scores range from a minimum of 0 to a maximum of 28, where higher total scores represent increasingly impaired professional functioning. |
| Change in subjective everyday cognitive functioning in active vs. control groups | 8 weeks | Assessed via the Cognitive Failures Questionnaire (CFQ), which assesses lapses of attention, perception and memory in real-life. Total score ranges from a minimum of 0 to a maximum of 100, where higher scores represent increased everyday cognitive failures. |
| Measure of engagement with bWell-D remediation in active vs. control groups | 8 weeks | Assessed using the User Engagement Scale (UES). There is a minimum score of 0 and a maximum score of 235.62, where higher scores represent increased engagement. |
| Measure of tolerability of bWell-D remediation in active vs. control groups | 8 weeks | Assessed using Simulator Sickness Questionnaire (SSQ). Patients rate the presence and severity of various symptoms of cybersickness, including nausea and ocular discomfort. There is a minimum score of 4 and a maximum score of 20, where higher scores represent increased simulator sickness. |
Countries
Canada
Contacts
CONTACTTrisha Chakrabarty, MD
CONTACTFaranak Farzan, PhD
PRINCIPAL_INVESTIGATORTrisha Chakrabarty, MD
University of British Columbia
Outcome results
None listed