Psychotic DisordersNCT05973110
Examining the Efficacy of a Virtual Reality Cognitive Remediation Program for People Living With Psychosis
A study testing Cognitive Remediation in people with Psychotic Disorders and Schizophrenia, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Psychotic Disorders, Schizophrenia, Schizo Affective Disorder
- What is being tested?
- Cognitive Remediation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jul 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Royal Ottawa Mental Health Centre
Ottawa, Ontario, K1Z 7K4
Synthia Guimond, PhD, 613-722-6521 ext. 6586, synthia.guimond@theroyal.ca
About this study
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.
Read the detailed description
Eligible participants will be administered various clinical (including a module from the Mini International Neuropsychiatric Interview and the Wechsler Abbreviated Scale Intelligence (WASI) to confirm eligibility), neurocognitive, social-cognitive, and community functioning assessments across two baseline visits. Participants are then randomly assigned to one of two study arms (a cognitive remediation intervention and active control, both using virtual reality). Regardless of the study arm assignment, participants will complete a six weeks (12 visits) training program where they will complete exercises in virtual reality and converse with study staff about a pre-selected topic. After each training visits, participants will also complete short questionnaires about their experience. One-week and three-months post-intervention, participants will complete the same assessments administered during the baseline visits. Also, at the one-week post-intervention time point, participants will complete a satisfaction with cognitive remediation program questionnaire.
The investigators will also use ecological momentary assessments (EMAs) delivered through a smartphone app to measure changes in thinking skills and daily life functioning within the context of this clinical trial. At the first visit, the investigators will invite participants to download the EMA app, DigiSensing, to their phone. DigiSensing is built from the open access MindLamp app, which has been used to measure neurocognition in previous studies. Through the DigiSensing app, the investigators will deliver three, ten-minute assessments at baseline, one-week post-intervention, and six-months post-intervention. Each assessment has thinking skill tasks, and questions about mood, clinical symptoms, thinking skills, and daily life functioning.
- Being tested
- Cognitive Remediation, Active Control
- Keywords
- Psychotic Disorders, Cognitive Remediation, Virtual Reality, Neurocognition, Social Cognition, Community Functioning
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Remediation | Experimental | Not described Receives: Behavioral: Cognitive Remediation |
| Active Control | Active comparator | Not described Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Intervention (attrition rate).
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.
Measured: The training completion will be computed at the 1-week post-intervention timepoint.
Feasibility of the intervention (homework completion).
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.
Measured: Homework completion will be computed at the 1-week post-intervention timepoint.
Feasibility of the intervention (cybersickness).
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.
Measured: 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
The acceptability of the intervention will be measured through a study-specific satisfaction with cognitive remediation intervention questionnaire.
Measured: 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.
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.
Measured: The Treatment Acceptability/Adherence Scale will be administered at the sixth intervention visit (3 weeks in the intervention) and 1-week post-intervention.
Secondary outcomes (12)
Feasibility of Integrating EMAs into a Clinical Trial
The investigators will assess the feasibility of integrating EMAs into a clinical trial by calculating the overall completion rate of the EMA survey (number of EMA surveys completed divided by the total number of EMA surveys).
Measured: The completion of the EMA surveys will be computed at the 6-months post-intervention timepoint.
Change in the community functioning performance from baseline to 1-week and 3-months post-intervention (Role Functioning Scale).
The investigators will measure community functioning through the Role Functioning Scale. Each of the 4 items of the Role Functioning Scale is scored on a scale of 1 to 7. The total score is from 4 to 28 with a higher score indicating a greater community functioning.
Measured: Participants complete the Role Functioning Scale at baseline, 1-week post-intervention, and 3-months post-intervention.
Change in the community functioning performance from baseline to 1-week and 3-months post-intervention ( modified Global Assessment of Functioning Scale).
The investigators will measure community functioning through the modified Global Assessment of Functioning Scale. The total score is from 0 to 100 with higher score indicating a greater functioning.
Measured: Participants complete the modified Global Assessment of Functioning at baseline, 1-week post-intervention, and 3-months post-intervention
Change in the community functioning performance from baseline to 1-week and 3-months post-intervention (UCSD performance-based skills assessment brief).
The investigators will measure community functioning through the UCSD performance-based skills assessment brief. The total score is from 0 to 100 with higher score indicating a greater performance in community functioning.
Measured: Participants complete the measure at baseline, 1-week post-intervention, and 3 months post-intervention.]
Change in social cognition performance from baseline to 1-week and 3-months post-intervention (The Hinting Task).
The investigators will measure the social cognition domain, theory of mind, using the The Hinting Task. Each of the 10 items of the Hinting Task is scored on a scale from 0 to 2. The total score ranges from 0 to 20 with higher scores indicating greater theory of mind abilities.
Measured: Participants complete the Hinting Task test at baseline, 1-week post-intervention, and 3 months post-intervention
Change in social cognition performance from baseline to 1-week and 3-months post-intervention (Emotion Regulation Questionnaire).
The investigators will measure the social cognition domain, emotion regulation, using the Emotion Regulation Questionnaire. Each of the 10 items of the Emotion Recognition Questionnaire is rated on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). The total score ranges from 10 to 70, with higher scores indicating a greater emotion regulation abilities.
Measured: Participants complete the Emotion Regulation Questionnaire test at baseline, 1-week post-intervention, and 3-months post-intervention.
Change in social cognition performance from baseline to 1-week and 3-months post-intervention (Ambiguous Intentions Hostility Questionnaire).
The investigators will measure the social cognition domain, attribution bias, using the Ambiguous Intentions Hostility Questionnaire. The Ambiguous Intentions Hostility Questionnaire is rated on a Likert Scale. The total score ranges from 3 to 16, with higher scores indicating greater blame, perceived intention, and anger.
Measured: Participants complete the Ambiguous Intentions Hostility Questionnaire at baseline, 1-week post-intervention, and 3-months post-intervention
Change in social-cognitive performance from baseline to 1-week and 3-months post-intervention (PENN emotion recognition task).
The investigators will measure the social cognition domain, emotion recognition, using the PENN emotion recognition task. The total score ranges from 0 to 40, with higher scores indicating greater emotion recognition ability.
Measured: Time Frame: Participants complete the PENN emotion recognition task at baseline, 1-week post-intervention, and 3-months post-intervention
Change in neurocognitive performance from baseline to 1-week and 3-months post- intervention (Cambridge Automated Neuropsychology Battery).
The investigators will measure neurocognition using nine subtests from the Cambridge Automated Neuropsychology Battery, in which a composite z-score will be computed to represent the cognitive domains measured.
Measured: Participants complete the Cambridge Automated Neuropsychology Battery at baseline, 1-week post-intervention, and 3-months post-intervention
Change in the EMA Neurocognition performance from baseline to 1-week and 6-months post-intervention - Jewel task
The investigators will measure neurocognition through the EMA survey using a Jewels Trail test, which is modelled after the Trail Making Test. A greater response time on the Jewels Trail test indicates decreased neurocognitive performance.
Measured: Participants complete the Jewels task through the DigiSensing App at baseline, 1-week post-intervention, and 6-months post-intervention.
Change in the EMA Community Functioning performance from baseline to 1-week and 6-months post-intervention ( Questionnaire about Process to Recovery).
The investigators will measure community functioning through the EMA survey using the Questionnaire about Process to Recovery. Each of the 15 items of the Questionnaire about Process to Recovery is rated on a 4-point Likert-type scale, with responses ranging from 0 ("disagree strongly") to 4 ("agree strongly"). The total score ranges from 0 to 60, with higher scores indicating a greater recovery.
Measured: Participants complete the Questionnaire about Process to Recovery through the DigiSensing app at baseline, 1-week post-intervention, and 6-months post-intervention
Change in the EMA Community Functioning performance from baseline to 1-week and 6-months post-intervention (Social Functioning Questionnaire).
The investigators will measure community functioning through the EMA survey using the Social Functioning Questionnaire.Each of the 8 items of the Social Functioning Questionnaire is scored on a scale ranging from 0 to 3 points. The total score ranges from 0 to 24 with higher scores representing poorer social functioning.
Measured: Participants complete the Social Functioning Questionnaire through the DigiSensing app at baseline, 1-week post-intervention, and 6-months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start31 Jul 2023
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either 12 sessions over 6 weeks of a cognitive remediation intervention or 12 sessions over 6 weeks of an active control intervention. Both conditions will involve activities in virtual reality.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, The Royal's Institute of Mental Health Research
- Responsible party
- Principal investigator, Synthia Guimond, The Royal Ottawa Mental Health Centre
- Investigators
- Synthia Guimond, PhD, Principal investigator, Royal Ottawa Mental Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973110
- Sponsor's protocol ID
- 2023001
- Status last verified
- Apr 2026
- First submitted
- 4 Jul 2023
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data collected from this study may be shared with other researchers at the Royal's Institute of Mental Health Research for analyses and re-analyses. Variables of the study and scripts used for analyses will be made available to the public. De-identified data will also be shared with the general public and researchers upon request. Data that can connect with participants' identity will NOT be used or shared for analyses.
Publications
Jahn FS, Skovbye M, Obenhausen K, Jespersen AE, Miskowiak KW. Cognitive training with fully immersive virtual reality in patients with neurological and psychiatric disorders: A systematic review of randomized controlled trials. Psychiatry Res. 2021 Jun;300:113928. doi: 10.1016/j.psychres.2021.113928. Epub 2021 Apr 6.
PubMed 33857847National Institute of Mental Health (n.d.). Schizophrenia. https://www.nimh.nih.gov/health/topics/schizophrenia
Viertio S, Tuulio-Henriksson A, Perala J, Saarni SI, Koskinen S, Sihvonen M, Lonnqvist J, Suvisaari J. Activities of daily living, social functioning and their determinants in persons with psychotic disorder. Eur Psychiatry. 2012 Aug;27(6):409-15. doi: 10.1016/j.eurpsy.2010.12.005. Epub 2011 Mar 5.
PubMed 21377336Schroeder AH, Bogie BJM, Rahman TT, Therond A, Matheson H, Guimond S. Feasibility and Efficacy of Virtual Reality Interventions to Improve Psychosocial Functioning in Psychosis: Systematic Review. JMIR Ment Health. 2022 Feb 18;9(2):e28502. doi: 10.2196/28502.
PubMed 35179501Shvetz C, Gu F, Drodge J, Torous J, Guimond S. Validation of an ecological momentary assessment to measure processing speed and executive function in schizophrenia. NPJ Schizophr. 2021 Dec 21;7(1):64. doi: 10.1038/s41537-021-00194-9.
PubMed 34934063Torous, J., Wisniewski, H., Bird, B., Carpenter, E., David, G., Elejalde, E., Fulford, D., Guimond, S., Hays, R., Henson, P., Hoffman, L., Lim, C., Menon, M., Noel, V., Pearson, J., Peterson, R., Susheela, A., Troy, H., Vaidyam, A., & Weizenbaum, E. (2019). Creating a Digital Health Smartphone App and Digital Phenotyping Platform for Mental Health and Diverse Healthcare Needs: an Interdisciplinary and Collaborative Approach. Journal of Technology in Behavioral Science, 4(2), 73-85. https://doi.org/10.1007/s41347-019-00095-w
Yee, J., Matheson, H., Bogie, B. J. M., Thérond, A., Charest, M., van Driel, C., Lei, Y-T., Noël, C., Goyette, M., Cretu, A. M., Tremblay, S., Morris, C., Attwood, D., Baines, A., Stewart, A., Bouchard, S., Bowie, C.R., & Guimond, S. (2023). The development of a user-centered and co-designed virtual reality cognitive remediation program for people living with a psychotic disorder [Manuscript in preparation]. Institute of Mental Health Research, The Royal Ottawa Mental Health Centre.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of a Virtual Reality Cognitive Remediation Program for People Living With Psychosis
- ClinicalTrials.gov ID
- NCT05973110
- Acronym / sponsor ID
- 2023001
- Keywords
- Psychotic Disorders, Cognitive Remediation, Virtual Reality, Neurocognition, Social Cognition, Community Functioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- The Royal Ottawa Mental Health CentreUniversity, hospital or other
- Collaborators
- Fonds de la Recherche en Santé du Québec, The Royal's Institute of Mental Health Research
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible participants will be administered various clinical (including a module from the Mini International Neuropsychiatric Interview and the Wechsler Abbreviated Scale Intelligence (WASI) to confirm eligibility), neurocognitive, social-cognitive, and community functioning assessments across two baseline visits. Participants are then randomly assigned to one of two study arms (a cognitive remediation intervention and active control, both using virtual reality). Regardless of the study arm assignment, participants will complete a six weeks (12 visits) training program where they will complete exercises in virtual reality and converse with study staff about a pre-selected topic. After each training visits, participants will also complete short questionnaires about their experience. One-week and three-months post-intervention, participants will complete the same assessments administered during the baseline visits. Also, at the one-week post-intervention time point, participants will complete a satisfaction with cognitive remediation program questionnaire.
The investigators will also use ecological momentary assessments (EMAs) delivered through a smartphone app to measure changes in thinking skills and daily life functioning within the context of this clinical trial. At the first visit, the investigators will invite participants to download the EMA app, DigiSensing, to their phone. DigiSensing is built from the open access MindLamp app, which has been used to measure neurocognition in previous studies. Through the DigiSensing app, the investigators will deliver three, ten-minute assessments at baseline, one-week post-intervention, and six-months post-intervention. Each assessment has thinking skill tasks, and questions about mood, clinical symptoms, thinking skills, and daily life functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized to either 12 sessions over 6 weeks of a cognitive remediation intervention or 12 sessions over 6 weeks of an active control intervention. Both conditions will involve activities in virtual reality.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation | Experimental | Behavioral: Cognitive Remediation |
| Active Control | Active comparator | Behavioral: Active Control |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive RemediationIn 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 | Cognitive Remediation |
| Active ControlIn 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. | Behavioural | Active Control |
Primary outcome
Feasibility of the Intervention (attrition rate).
Time frame: 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).
Time frame: 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).
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.
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
Time frame: 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.
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.
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.
12 secondary outcomes
Feasibility of Integrating EMAs into a Clinical Trial
Time frame: The completion of the EMA surveys will be computed at the 6-months post-intervention timepoint.
Change in the community functioning performance from baseline to 1-week and 3-months post-intervention (Role Functioning Scale).
Time frame: Participants complete the Role Functioning Scale at baseline, 1-week post-intervention, and 3-months post-intervention.
Change in the community functioning performance from baseline to 1-week and 3-months post-intervention ( modified Global Assessment of Functioning Scale).
Time frame: Participants complete the modified Global Assessment of Functioning at baseline, 1-week post-intervention, and 3-months post-intervention
Change in the community functioning performance from baseline to 1-week and 3-months post-intervention (UCSD performance-based skills assessment brief).
Time frame: Participants complete the measure at baseline, 1-week post-intervention, and 3 months post-intervention.]
Change in social cognition performance from baseline to 1-week and 3-months post-intervention (The Hinting Task).
Time frame: Participants complete the Hinting Task test at baseline, 1-week post-intervention, and 3 months post-intervention
Change in social cognition performance from baseline to 1-week and 3-months post-intervention (Emotion Regulation Questionnaire).
Time frame: Participants complete the Emotion Regulation Questionnaire test at baseline, 1-week post-intervention, and 3-months post-intervention.
Change in social cognition performance from baseline to 1-week and 3-months post-intervention (Ambiguous Intentions Hostility Questionnaire).
Time frame: Participants complete the Ambiguous Intentions Hostility Questionnaire at baseline, 1-week post-intervention, and 3-months post-intervention
Change in social-cognitive performance from baseline to 1-week and 3-months post-intervention (PENN emotion recognition task).
Time frame: Time Frame: Participants complete the PENN emotion recognition task at baseline, 1-week post-intervention, and 3-months post-intervention
Change in neurocognitive performance from baseline to 1-week and 3-months post- intervention (Cambridge Automated Neuropsychology Battery).
Time frame: Participants complete the Cambridge Automated Neuropsychology Battery at baseline, 1-week post-intervention, and 3-months post-intervention
Change in the EMA Neurocognition performance from baseline to 1-week and 6-months post-intervention - Jewel task
Time frame: Participants complete the Jewels task through the DigiSensing App at baseline, 1-week post-intervention, and 6-months post-intervention.
Change in the EMA Community Functioning performance from baseline to 1-week and 6-months post-intervention ( Questionnaire about Process to Recovery).
Time frame: Participants complete the Questionnaire about Process to Recovery through the DigiSensing app at baseline, 1-week post-intervention, and 6-months post-intervention
Change in the EMA Community Functioning performance from baseline to 1-week and 6-months post-intervention (Social Functioning Questionnaire).
Time frame: Participants complete the Social Functioning Questionnaire through the DigiSensing app at baseline, 1-week post-intervention, and 6-months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 33857847Jahn FS, Skovbye M, Obenhausen K, Jespersen AE, Miskowiak KW. Cognitive training with fully immersive virtual reality in patients with neurological and psychiatric disorders: A systematic review of randomized controlled trials. Psychiatry Res. 2021 Jun;300:113928. doi: 10.1016/j.psychres.2021.113928. Epub 2021 Apr 6.
- BackgroundNational Institute of Mental Health (n.d.). Schizophrenia. https://www.nimh.nih.gov/health/topics/schizophrenia
- Background: PubMed 21377336Viertio S, Tuulio-Henriksson A, Perala J, Saarni SI, Koskinen S, Sihvonen M, Lonnqvist J, Suvisaari J. Activities of daily living, social functioning and their determinants in persons with psychotic disorder. Eur Psychiatry. 2012 Aug;27(6):409-15. doi: 10.1016/j.eurpsy.2010.12.005. Epub 2011 Mar 5.
- Background: PubMed 35179501Schroeder AH, Bogie BJM, Rahman TT, Therond A, Matheson H, Guimond S. Feasibility and Efficacy of Virtual Reality Interventions to Improve Psychosocial Functioning in Psychosis: Systematic Review. JMIR Ment Health. 2022 Feb 18;9(2):e28502. doi: 10.2196/28502.
- Background: PubMed 34934063Shvetz C, Gu F, Drodge J, Torous J, Guimond S. Validation of an ecological momentary assessment to measure processing speed and executive function in schizophrenia. NPJ Schizophr. 2021 Dec 21;7(1):64. doi: 10.1038/s41537-021-00194-9.
- BackgroundTorous, J., Wisniewski, H., Bird, B., Carpenter, E., David, G., Elejalde, E., Fulford, D., Guimond, S., Hays, R., Henson, P., Hoffman, L., Lim, C., Menon, M., Noel, V., Pearson, J., Peterson, R., Susheela, A., Troy, H., Vaidyam, A., & Weizenbaum, E. (2019). Creating a Digital Health Smartphone App and Digital Phenotyping Platform for Mental Health and Diverse Healthcare Needs: an Interdisciplinary and Collaborative Approach. Journal of Technology in Behavioral Science, 4(2), 73-85. https://doi.org/10.1007/s41347-019-00095-w
- BackgroundYee, J., Matheson, H., Bogie, B. J. M., Thérond, A., Charest, M., van Driel, C., Lei, Y-T., Noël, C., Goyette, M., Cretu, A. M., Tremblay, S., Morris, C., Attwood, D., Baines, A., Stewart, A., Bouchard, S., Bowie, C.R., & Guimond, S. (2023). The development of a user-centered and co-designed virtual reality cognitive remediation program for people living with a psychotic disorder [Manuscript in preparation]. Institute of Mental Health Research, The Royal Ottawa Mental Health Centre.
- Individual participant dataSharing planned: Yes. De-identified data collected from this study may be shared with other researchers at the Royal's Institute of Mental Health Research for analyses and re-analyses. Variables of the study and scripts used for analyses will be made available to the public. De-identified data will also be shared with the general public and researchers upon request. Data that can connect with participants' identity will NOT be used or shared for analyses.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Synthia Guimond, PhD principal investigator
Royal Ottawa Mental Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation in people with Psychotic Disorders and Schizophrenia, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Synthia Guimond, PhD (613-722-6521 ext. 6586, synthia.guimond@theroyal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention (attrition rate). (time frame: The training completion will be computed at the 1-week post-intervention timepoint.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05973110, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.