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View on ClinicalTrials.gov

Testing Cognitive Remediation for psychotic disorders

Official title: Examining the Efficacy of a Virtual Reality Cognitive Remediation Program for People Living With Psychosis

Condition: Psychotic DisordersSponsor: The Royal Ottawa Mental Health CentreTarget enrollment: 52
  • 2 groups
  • One site, in Ottawa
  • Recruiting
Royal Ottawa Mental Health Centre, Ottawa, Ontario

Interventions

  • Behavioural therapy

    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.

  • Behavioural therapy

    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.

Canadian Sites (1)

1 of 1 recruiting

  • Royal Ottawa Mental Health Centre

    Ottawa, Ontario

    Recruiting

Eligibility Criteria

See who this study is looking for11 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Equal or between 18 to 60 years old
  • +Be clinically stable, as defined as a total Positive And Negative Severity Symptoms score equal or between 30 - 95
  • +Diagnosis of a psychosis-spectrum disorder
  • +Ability to read and speak English
  • +No changes to their medication dosage, starting a new medication, or stopping a medication within the past month before signing the consent formInformed consentThe process of being told what taking part involves, then choosing freely.Read more →

Exclusion

  • 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
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Cognitive Remediation.

Registry label: A: Cognitive Remediation

Group B, the comparison group, receives Active ControlControl groupThe group a new treatment is measured against.Read more →.

Registry label: B: Active Control

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

Neither you nor the study team would know which group you are in until the study ends.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists an age range of 18 years to 60 years.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 52 people.

The study is currently expected to finish around December 2026.

The main measurement is taken over: The training completion will be computed at the 1-week post-intervention timepoint.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Feasibility of the Intervention (attrition rate) — measured over The training completion will be computed at the 1-week post-intervention timepoint.

Feasibility of the intervention (homework completion) — measured over Homework completion will be computed at the 1-week post-intervention timepoint.

Feasibility of the intervention (cybersickness) — measured over 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 — measured over The satisfaction questionnaire will be administered at the 1-week post-intervention time point.

The study lists 1 further main measurements.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05973110 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Cognitive RemediationBehavioural

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.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

About Active ControlBehavioural

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.

From the trial registry — its own words, unedited.

What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: an age range of 18 years to 60 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

Neither you nor the study team would know which group you are in until the study ends.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists an age range of 18 years to 60 years.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.maximumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: The training completion will be computed at the 1-week post-intervention timepoint..

The study as a whole is currently expected to finish around 2026-12.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 52 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Ottawa, Ontario, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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.

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.