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Behavioral Intervention

Virtual Reality Cognitive Remediation for Psychosis

N/A
Recruiting
Led By Synthia Guimond, PhD
Research Sponsored by The Royal Ottawa Mental Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up participants complete the subjective scale to investigate cognition in schizophrenia - brief at baseline, 1-week post-intervention, 3-months post-intervention, and 6-months post-intervention.
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a cognitive intervention using virtual reality to help people living with psychotic disorders better manage their thinking and social skills to improve day-to-day life.

Who is the study for?
This trial is for people aged 20-55 with a psychosis-spectrum disorder like schizophrenia, who speak English and have had stable medication doses for the past month. It's not suitable for those with cognitive impairments from other conditions, no smartphone, seizure history, severe eye/ear/balance issues, significant brain injury, intellectual disability or recent substance abuse.
What is being tested?
The study tests a virtual reality program designed to improve thinking and social skills in individuals with psychotic disorders. Participants will use VR as part of cognitive remediation therapy to see if it helps them better manage daily activities and relationships.
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort or dizziness due to VR usage; however these are generally mild and can be managed by adjusting the duration of VR sessions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants complete the subjective scale to investigate cognition in schizophrenia - brief at baseline, 1-week post-intervention, 3-months post-intervention, and 6-months post-intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants complete the subjective scale to investigate cognition in schizophrenia - brief at baseline, 1-week post-intervention, 3-months post-intervention, and 6-months post-intervention. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of the intervention
Change in neurocognitive performance from baseline to 1-week and 3-months post- intervention (Cambridge Automated Neuropsychology Battery).
Change in social cognition performance from baseline to 1-week and 3-months post-intervention (Ambiguous Intentions Hostility Questionnaire).
+10 more
Secondary study objectives
Change in the EMA Community Functioning performance from baseline to 1-week and 6-months post-intervention ( Questionnaire about Process to Recovery).
Change in the EMA Community Functioning performance from baseline to 1-week and 6-months post-intervention (Social Functioning Questionnaire).
Change in the EMA Neurocognition performance from baseline to 1-week and 6-months post-intervention - Jewel task
+1 more
Other study objectives
Affect
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.
Change in Symptom Severity from baseline to 1-week post-intervention and 3-months post-intervention.
+8 more

Side effects data

From 2013 Phase 3 trial • 120 Patients • NCT01173874
7%
Exacerbation
2%
abnormal ECG
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cognitive Remediation
Cognitive Activity Control Group

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cognitive RemediationExperimental Treatment1 Intervention
Group II: Active ControlActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Remediation
2010
Completed Phase 3
~1790

Find a Location

Who is running the clinical trial?

The Royal Ottawa Mental Health CentreLead Sponsor
19 Previous Clinical Trials
2,048 Total Patients Enrolled
Fonds de la Recherche en Santé du QuébecOTHER_GOV
83 Previous Clinical Trials
46,597 Total Patients Enrolled
The Royal's Institute of Mental Health ResearchOTHER
5 Previous Clinical Trials
1,138 Total Patients Enrolled
Synthia Guimond, PhDPrincipal InvestigatorRoyal Ottawa Mental Health Centre
2 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Active Control (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05973110 — N/A
Modeling Psychosis Research Study Groups: Cognitive Remediation, Active Control
Modeling Psychosis Clinical Trial 2023: Active Control Highlights & Side Effects. Trial Name: NCT05973110 — N/A
Active Control (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05973110 — N/A
~3 spots leftby Feb 2025