Cognitive Remediation: In 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: In 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
* No changes to their medication dosage, starting a new medication, or stopping a medication within the past month before signing the consent form
Exclusion Criteria:
* 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
* Any severe medical condition related to the eyes, ears, and balance
* History of substance use disorder within the last 3 months
Primary outcome measure(s)
Feasibility of the Intervention (attrition rate). — The training completion will be computed at the 1-week post-intervention timepoint. 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). — Homework completion will be computed at the 1-week post-intervention timepoint. 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). — Participants complete the Simulator Sickness Questionnaire at each intervention visit, which is scheduled twice a week for six weeks. The composite mean score will be computed at the 1-week post-training time point for each participant. 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 satisfaction questionnaire will be administered at the 1-week post-intervention time point. The acceptability of the intervention will be measured through a study-specific satisfaction with cognitive remediation intervention questionnaire.
Change in the acceptability of the intervention from the sixth intervention visit (3 weeks in intervention) to 1-week post-intervention. — The Treatment Acceptability/Adherence Scale will be administered at the sixth intervention visit (3 weeks in the intervention) and 1-week post-intervention. The acceptability of the intervention will be measured through the Treatment Acceptability/Adherence Scale (TAAS). Each of the 10 items of The Treatment Acceptability/Adherence Scale is rated on a 7-point Likert-type scale, with responses ranging from 1 ("strongly disagree") to 7 ("strongly agree "). The total score ranges from 10 to 70 with higher score indicating greater acceptability of treatment and greater anticipated ability to adhere to it.
Trial sites (1)
Facility
City
Region
Status
Royal Ottawa Mental Health Centre
Ottawa
Ontario
Recruiting
More The Royal Ottawa Mental Health Centre trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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