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

NCT05973110 | Recruiting

• 1 other identifier: 2023001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Psychotic Disorders; Schizophrenia; Schizo Affective Disorder

Keywords

Psychotic Disorders; Cognitive Remediation; Virtual Reality; Neurocognition; Social Cognition; Community Functioning

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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 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).

  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).

  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).

  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).

  Participants complete the Hinting Task test at baseline, 1-week post-intervention, and 3 months post-intervention

Other Outcomes (11)

• Symptom Severity at baseline

  Participants complete the Positive and Negative Severity Scale at baseline.

• Change in Symptom Severity from baseline to 1-week post-intervention and 3-months post-intervention.

  Participants complete the brief version of the Positive and Negative Severity Scale at 1-week post-intervention and 3-months post-intervention.

• 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.

  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.

Study Arms (2)

Cognitive Remediation

EXPERIMENTAL

Behavioral: Cognitive Remediation

Active Control

ACTIVE COMPARATOR

Behavioral: Active Control

Interventions

Cognitive Remediation 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.

Cognitive Remediation

Active Control 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.

Active Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fonds de la Recherche en Santé du Québec: collaborator
• The Royal's Institute of Mental Health Research: collaborator
• The Royal Ottawa Mental Health Centre: lead

Study Sites (1)

Royal Ottawa Mental Health Centre

Ottawa, Ontario, K1Z 7K4, Canada

RECRUITING

Related Publications (7)

• 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.

  PMID: 33857847 BACKGROUND

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

  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.

  PMID: 21377336 BACKGROUND

• 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.

  PMID: 35179501 BACKGROUND

• 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.

  PMID: 34934063 BACKGROUND

• 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

  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.

  BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Synthia Guimond, PhD

  Royal Ottawa Mental Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Synthia Guimond, PhD

CONTACT

613-722-6521; synthia.guimond@theroyal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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. The investigator became unblinded mid-way through the project in order to analyze and present some preliminary data. The purpose of this presentation was to secure further funding for the project's continuation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: 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.

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: August 2, 2023
• Study Start: July 31, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified data will become available upon completion of the study and once results have been published in an academic journal (anticipated year of publication: 2026).
• Access Criteria: Upon request to Synthia Guimond

Locations

CA (1)