Clinical trial NCT05973110: Examining the Efficacy of a Virtual Reality Cognitive Remediation Program for People Living With Psychosis
Official title: Examining the Efficacy of a Virtual Reality Cognitive Remediation Program for People Living With Psychosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychotic Disorders
Schizophrenia
Schizo Affective Disorder
Keywords: Psychotic Disorders
Cognitive Remediation
Virtual Reality
Neurocognition
Social Cognition
Community Functioning
Lead sponsor: The Royal Ottawa Mental Health Centre
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
name: The Royal's Institute of Mental Health Research
First posted: 2023-08-02
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in neurocognitive performance from baseline to 1-week and 3-months post- intervention (Cambridge Automated Neuropsychology Battery).
timeFrame: Participants complete the Cambridge Automated Neuropsychology Battery at baseline, 1-week post-intervention, and 3-months post-intervention
measure: Change in social-cognitive performance from baseline to 1-week and 3-months post-intervention (PENN emotion recognition task).
timeFrame: Time Frame: Participants complete the PENN emotion recognition task at baseline, 1-week post-intervention, and 3-months post-intervention
measure: Change in social cognition performance from baseline to 1-week and 3-months post-intervention (Ambiguous Intentions Hostility Questionnaire).
timeFrame: Participants complete the Ambiguous Intentions Hostility Questionnaire at baseline, 1-week post-intervention, and 3-months post-intervention
measure: Change in social cognition performance from baseline to 1-week and 3-months post-intervention (Emotion Regulation Questionnaire).
timeFrame: Participants complete the Emotion Regulation Questionnaire test at baseline, 1-week post-intervention, and 3-months post-intervention.
measure: Change in social cognition performance from baseline to 1-week and 3-months post-intervention (The Hinting Task).
timeFrame: Participants complete the Hinting Task test at baseline, 1-week post-intervention, and 3 months post-intervention
measure: Change in the community functioning performance from baseline to 1-week and 3-months post-intervention (UCSD performance-based skills assessment brief).
timeFrame: Participants complete the measure at baseline, 1-week post-intervention, and 3 months post-intervention.]
measure: Change in the community functioning performance from baseline to 1-week and 3-months post-intervention ( modified Global Assessment of Functioning Scale).
timeFrame: Participants complete the modified Global Assessment of Functioning at baseline, 1-week post-intervention, and 3-months post-intervention
measure: Change in the community functioning performance from baseline to 1-week and 3-months post-intervention (Role Functioning Scale).
timeFrame: Participants complete the Role Functioning Scale at baseline, 1-week post-intervention, and 3-months post-intervention.
measure: Feasibility of the Intervention (attrition rate).
timeFrame: The training completion will be computed at the 1-week post-intervention timepoint.
measure: Feasibility of the intervention (homework completion).
timeFrame: Homework completion will be computed at the 1-week post-intervention timepoint.
measure: Feasibility of the intervention (cybersickness).
timeFrame: 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.
measure: Acceptability of the intervention
timeFrame: The satisfaction questionnaire will be administered at the 1-week post-intervention time point.
measure: Change in the acceptability of the intervention from the sixth intervention visit (3 weeks in intervention) to 1-week post-intervention.
timeFrame: 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:
measure: Feasibility of Integrating EMAs into a Clinical Trial
timeFrame: The completion of the EMA surveys will be computed at the 6-months post-intervention timepoint.
measure: Change in the EMA Neurocognition performance from baseline to 1-week and 6-months post-intervention - Jewel task
timeFrame: Participants complete the Jewels task through the DigiSensing App at baseline, 1-week post-intervention, and 6-months post-intervention.
measure: Change in the EMA Community Functioning performance from baseline to 1-week and 6-months post-intervention ( Questionnaire about Process to Recovery).
timeFrame: Participants complete the Questionnaire about Process to Recovery through the DigiSensing app at baseline, 1-week post-intervention, and 6-months post-intervention
measure: Change in the EMA Community Functioning performance from baseline to 1-week and 6-months post-intervention (Social Functioning Questionnaire).
timeFrame: Participants complete the Social Functioning Questionnaire through the DigiSensing app at baseline, 1-week post-intervention, and 6-months post-intervention.
Other outcomes:
measure: Symptom Severity at baseline
timeFrame: Participants complete the Positive and Negative Severity Scale at baseline.
measure: Change in Symptom Severity from baseline to 1-week post-intervention and 3-months post-intervention.
timeFrame: Participants complete the brief version of the Positive and Negative Severity Scale at 1-week post-intervention and 3-months post-intervention.
measure: 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.
timeFrame: 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.
measure: Intrinsic Motivation
timeFrame: Participants complete the Intrinsic Motivation Inventory for Schizophrenia Research at baseline.]
measure: Motivation
timeFrame: Participants complete the Basic Psychological Need Satisfaction and Frustration Scale at baseline.]
measure: Social Support (Friends)
timeFrame: Participants complete the Perceived Social Support from Friends at baseline.
measure: Social Support (Family)
timeFrame: Participants complete the Perceived Social Support from Family at baseline.
measure: Change in level of stress performance from baseline to 1-week and 3-months post-intervention (Perceived Stress Scale).
timeFrame: Participants complete the Perceived Stress Scale at baseline, 1-week post-intervention, and 3-months post-intervention.
measure: Change in stress resilience performance from baseline to 1-week and 3-months post-intervention (Brief Resilience Scale).
timeFrame: Participants complete the Brief Resilience Scale at baseline, 1-week post-intervention, and 3-months post-intervention.
measure: Affect
timeFrame: Participants complete the Core Affect Grid 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
measure: Change in the Therapeutic Alliance from sixth intervention (3-weeks in the intervention) to 1-week post-intervention
timeFrame: Participants complete the Work Alliance Inventory Short version at the sixth intervention visit (3 weeks in the intervention) and 1-week post-intervention.
Locations:
city: Ottawa
country: Canada
facility: Royal Ottawa Mental Health Centre
state: Ontario
Study officials:
affiliation: Royal Ottawa Mental Health Centre
name: Synthia Guimond, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: National Institute of Mental Health (n.d.). Schizophrenia. https://www.nimh.nih.gov/health/topics/schizophrenia
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.