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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 weeks3 visits
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.
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.
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 moreSecondary 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 moreOther 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 moreSide effects data
From 2013 Phase 3 trial • 120 Patients • NCT011738747%
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
7 Trials studying Schizophrenia
334 Patients Enrolled for Schizophrenia
Fonds de la Recherche en Santé du QuébecOTHER_GOV
82 Previous Clinical Trials
46,529 Total Patients Enrolled
The Royal's Institute of Mental Health ResearchOTHER
5 Previous Clinical Trials
1,138 Total Patients Enrolled
1 Trials studying Schizophrenia
40 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures or epilepsy.I have a condition that affects my thinking or memory.I have had a brain injury that made me lose consciousness.I have a severe condition affecting my eyes, ears, or balance.I am between 20 and 55 years old.I haven't changed, started, or stopped any medications in the last month.I have been diagnosed with a psychosis-spectrum disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Remediation
- Group 2: Active Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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