Recruiting

Virtual Reality

Sponsor:

The Royal Ottawa Mental Health Centre

Code:

NCT05973110

Conditions

Psychotic Disorders

Schizophrenia

Schizo Affective Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Cognitive Remediation

Active Control

Study Details

Brief 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.

Conditions

Psychotic Disorders

Schizophrenia

Schizo Affective Disorder

Study ID

NCT05973110

Start date

Jul 31, 2023

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

52 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cognitive Remediation

active comparator: Active Control

Interventions

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.

Primary outcome measure

  • Feasibility of the Intervention (attrition rate). [ Time Frame: The training completion will be computed at the 1-week post-intervention timepoint. ]
  • Feasibility of the intervention (homework completion). [ Time Frame: Homework completion will be computed at the 1-week post-intervention timepoint. ]
  • Feasibility of the intervention (cybersickness). [ Time Frame: 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. ]
  • Acceptability of the intervention [ Time Frame: The satisfaction questionnaire will be administered at the 1-week post-intervention time point. ]
  • Change in the acceptability of the intervention from the sixth intervention visit (3 weeks in intervention) to 1-week post-intervention. [ Time Frame: The Treatment Acceptability/Adherence Scale will be administered at the sixth intervention visit (3 weeks in the intervention) and 1-week post-intervention. ]

Central Contacts and Locations

Central contacts

Synthia Guimond, PhD

613-722-6521synthia.guimond@theroyal.ca

Locations

Royal Ottawa Mental Health Centre

Recruiting

Ottawa, Ontario, Canada, K1Z 7K4

Contacts

Synthia Guimond, PhD

613-722-6521synthia.guimond@theroyal.ca

More Information

Sponsor

The Royal Ottawa Mental Health Centre

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Psychotic Disorders
  • Cognitive Remediation
  • Virtual Reality
  • Neurocognition
  • Social Cognition
  • Community Functioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Royal Ottawa Mental Health Centre on 2026-04-16.