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

NCT ID: NCT05973110

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-31

Study Completion Date

2026-02-28

Brief Summary

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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

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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.

Conditions

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Psychotic Disorders Schizophrenia Schizo Affective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Due to the nature of the clinical trial, the study staff members delivering the intervention are unable to remain blind and are the only individuals who will be aware of the study arm assignment. Assessment staff members, investigators, and participants will be blinded to study arm assignment and will never be involved in the randomization.

Study Groups

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Cognitive Remediation

Group Type EXPERIMENTAL

Cognitive Remediation

Intervention Type BEHAVIORAL

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

Group Type ACTIVE_COMPARATOR

Active Control

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of a psychosis-spectrum disorder
* Equal or between 20 to 55 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
* 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
* Past traumatic brain injury resulting in a loss of consciousness
* Do not own a smartphone
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fonds de la Recherche en Santé du Québec

OTHER_GOV

Sponsor Role collaborator

The Royal's Institute of Mental Health Research

OTHER

Sponsor Role collaborator

The Royal Ottawa Mental Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Synthia Guimond

Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Synthia Guimond, PhD

Role: PRINCIPAL_INVESTIGATOR

Royal Ottawa Mental Health Centre

Locations

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Royal Ottawa Mental Health Centre

Ottawa, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Synthia Guimond, PhD

Role: CONTACT

[email protected]
613-722-6521 ext. 6586

Facility Contacts

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Synthia Guimond, PhD

Role: primary

[email protected]
613-722-6521 ext. 6586

References

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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.

Reference Type BACKGROUND
PMID: 33857847 (View on PubMed)

National Institute of Mental Health (n.d.). Schizophrenia. https://www.nimh.nih.gov/health/topics/schizophrenia

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 21377336 (View on PubMed)

Schroeder 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.

Reference Type BACKGROUND
PMID: 35179501 (View on PubMed)

Shvetz 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.

Reference Type BACKGROUND
PMID: 34934063 (View on PubMed)

Torous, 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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Other Identifiers

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2023001

Identifier Type: -

Identifier Source: org_study_id