Individuals living with a psychotic disorder often experience changes to their thinking and social skills that can lead to challenges with work, school, relationships and living independently. One intervention to target these areas is cognitive remediation therapy, which can be delivered in virtual reality to help apply the skills and strategies learned to day-to-day life. Over the past few years, our team has co-developed a cognitive remediation program in virtual reality with healthcare professionals and people with lived experiences of psychosis. The current trial tests the feasibility and efficacy of this cognitive remediation program in virtual reality at improving thinking skills, social skills, and daily life functioning.
Diagnosis of a psychosis-spectrum disorder
Equal or between 18 to 60 years old
Ability to read and speak English
Be clinically stable, as defined as a total Positive And Negative Severity Symptoms score equal or between 30 - 95
Neurological or medical disorders that may produce cognitive impairment (including head injury with more than 1 minute of loss of consciousness)
Intellectual disability or a score equal or below 70 on the Wechsler Abbreviated Scale of Intelligence.
Any vision conditions that cannot be corrected with contact lenses or glasses that can fit in the virtual reality googles.
Past history of seizures, fit, and epilepsy
Parallel
Cognitive Remediation
BehavioralIn each of the 12 visits, participants will complete exercises in virtual reality for two sessions of about 15 minutes separated by a break of 5 to 10 minutes. Participants then engage in a bridging conversation with study staff for about 15 minutes. More details about each condition will be added after study completion to protect the blinding of our participants.
Active Control
BehavioralIn each of the 12 visits, participants will complete exercises in virtual reality will complete exercises in virtual reality for two sessions of about 15 minutes separated by a break of 5 to 10 minutes. Participants then engage in a bridging conversation with study staff for around 10 to 15 minutes. More details about each condition will be added after study completion to protect the blinding of our participants.
Feasibility of the Intervention (attrition rate).
The investigators will measure the feasibility of the intervention by verifying adherence and attrition of participants. The percentage of participants who completed the training program will be computed after the participant completes their final intervention visits.
Feasibility of the intervention (homework completion).
The investigators will measure the feasibility of the intervention by verifying the homework completion by participants. The percentage of homework completion will be computed after the participant completes their final intervention visit.
Feasibility of the intervention (cybersickness).
The investigators will measure the feasibility of the intervention by creating a composite mean score of cybersickness reported on the Simulator Sickness Questionnaire for each participant. The Simulator Sickness Questionnaire is composed of 16, four-point Likert scale items with responses ranging from "never" to "severe". A higher score on the Simulator Sickness Questionnaire indicates greater cybersickness experienced.
Acceptability of the intervention
The acceptability of the intervention will be measured through a study-specific satisfaction with cognitive remediation intervention questionnaire.
Feasibility of Integrating EMAs into a Clinical Trial
The investigators will assess the feasibility of integrating EMAs into a clinical trial by calculating the overall completion rate of the EMA survey (number of EMA surveys completed divided by the total number of EMA surveys).
Change in the community functioning performance from baseline to 1-week and 3-months post-intervention (Role Functioning Scale).
The investigators will measure community functioning through the Role Functioning Scale. Each of the 4 items of the Role Functioning Scale is scored on a scale of 1 to 7. The total score is from 4 to 28 with a higher score indicating a greater community functioning.
Change in the community functioning performance from baseline to 1-week and 3-months post-intervention ( modified Global Assessment of Functioning Scale).
The investigators will measure community functioning through the modified Global Assessment of Functioning Scale. The total score is from 0 to 100 with higher score indicating a greater functioning.
Change in the community functioning performance from baseline to 1-week and 3-months post-intervention (UCSD performance-based skills assessment brief).
The investigators will measure community functioning through the UCSD performance-based skills assessment brief. The total score is from 0 to 100 with higher score indicating a greater performance in community functioning.
Symptom Severity at baseline
The investigators will measure symptom severity through the Positive and Negative Severity Scale. Each of the 30 items of the Positive and Negative Severity Scale is rated on a scale of 7 points and the total score ranges from 30 to 210, with higher scores indicating more severe psychotic disorder symptoms.
Change in Symptom Severity from baseline to 1-week post-intervention and 3-months post-intervention.
The investigators will measure symptom severity through the brief version of the PANSS (PANSS-6). Each of the 6 items of the brief version of the Positive and Negative Severity Scale is rated on a scale of 7 points and the total score ranges from 6 to 42 with higher scores indicating more severe symptoms of a psychotic disorder.
Change in Self-Reported Neurocognition performance from baseline to 1-week, 3-months and 6-months post intervention- Subjective Scale to Investigate Cognition in Schizophrenia - Brief.
The investigators will measure subjective perceptions of neurocognitive functioning through the Subjective Scale to Investigate Cognition in Schizophrenia - Brief (SSTICS-Brief). Each of the 14 items are scored on a 5 points Likert-type scale that extends from 0 ("never") to 4 ("very often"). The total score ranges from 0 to 56 with higher score indicating a higher perceived difficulty in neurocognition.
Intrinsic Motivation
The investigators will measure motivation through the Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR). The Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR) is rated on a 7-point Likert-type scale with responses ranging from 1 ("not at all true") to 7 ("very true"). The score ranges from 30 to 210 with higher scores indicating greater intrinsic motivation.
Click on the lead sponsor to view all of their trials.
The Royal Ottawa Mental Health Centre
Lead sponsor
Fonds de la Recherche en Santé du Québec
Collaborator
The Royal's Institute of Mental Health Research
Collaborator
