search
Back to results

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

Primary Purpose

Psychotic Disorders, Schizophrenia, Schizo Affective Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Remediation
Active Control
Sponsored by
The Royal Ottawa Mental Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotic Disorders focused on measuring Psychotic Disorders, Cognitive Remediation, Virtual Reality, Neurocognition, Social Cognition, Community Functioning

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Ottawa Mental Health CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive Remediation

Active Control

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Acceptability of the intervention
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.
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.

Secondary Outcome Measures

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).
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.
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.
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.

Full Information

First Posted
July 4, 2023
Last Updated
July 31, 2023
Sponsor
The Royal Ottawa Mental Health Centre
Collaborators
Fonds de la Recherche en Santé du Québec, The Royal's Institute of Mental Health Research
search

1. Study Identification

Unique Protocol Identification Number
NCT05973110
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Anticipated)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Royal Ottawa Mental Health Centre
Collaborators
Fonds de la Recherche en Santé du Québec, The Royal's Institute of Mental Health Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Schizophrenia, Schizo Affective Disorder
Keywords
Psychotic Disorders, Cognitive Remediation, Virtual Reality, Neurocognition, Social Cognition, Community Functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Remediation
Arm Type
Experimental
Arm Title
Active Control
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Remediation
Intervention Description
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
Intervention Name(s)
Active Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in neurocognitive performance from baseline to 1-week and 3-months post- intervention (Cambridge Automated Neuropsychology Battery).
Description
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.
Time Frame
Participants complete the Cambridge Automated Neuropsychology Battery at baseline, 1-week post-intervention, and 3-months post-intervention
Title
Change in social-cognitive performance from baseline to 1-week and 3-months post-intervention (PENN emotion recognition task).
Description
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.
Time Frame
Time Frame: Participants complete the PENN emotion recognition task at baseline, 1-week post-intervention, and 3-months post-intervention
Title
Change in social cognition performance from baseline to 1-week and 3-months post-intervention (Ambiguous Intentions Hostility Questionnaire).
Description
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.
Time Frame
Participants complete the Ambiguous Intentions Hostility Questionnaire at baseline, 1-week post-intervention, and 3-months post-intervention
Title
Change in social cognition performance from baseline to 1-week and 3-months post-intervention (Emotion Regulation Questionnaire).
Description
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.
Time Frame
Participants complete the Emotion Regulation Questionnaire test at baseline, 1-week post-intervention, and 3-months post-intervention.
Title
Change in social cognition performance from baseline to 1-week and 3-months post-intervention (The Hinting Task).
Description
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.
Time Frame
Participants complete the Hinting Task test at baseline, 1-week post-intervention, and 3 months post-intervention
Title
Change in the community functioning performance from baseline to 1-week and 3-months post-intervention (UCSD performance-based skills assessment brief).
Description
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.
Time Frame
Participants complete the measure at baseline, 1-week post-intervention, and 3 months post-intervention.]
Title
Change in the community functioning performance from baseline to 1-week and 3-months post-intervention ( modified Global Assessment of Functioning Scale).
Description
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.
Time Frame
Participants complete the modified Global Assessment of Functioning at baseline, 1-week post-intervention, and 3-months post-intervention
Title
Change in the community functioning performance from baseline to 1-week and 3-months post-intervention (Role Functioning Scale).
Description
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.
Time Frame
Participants complete the Role Functioning Scale at baseline, 1-week post-intervention, and 3-months post-intervention.
Title
Feasibility of the Intervention (attrition rate).
Description
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.
Time Frame
The training completion will be computed at the 1-week post-intervention timepoint.
Title
Feasibility of the intervention (homework completion).
Description
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.
Time Frame
Homework completion will be computed at the 1-week post-intervention timepoint.
Title
Feasibility of the intervention (cybersickness).
Description
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.
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.
Title
Acceptability of the intervention
Description
The acceptability of the intervention will be measured through a study-specific satisfaction with cognitive remediation intervention questionnaire.
Time Frame
The satisfaction questionnaire will be administered at the 1-week post-intervention time point.
Title
Change in the acceptability of the intervention from the sixth intervention visit (3 weeks in intervention) to 1-week post-intervention.
Description
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.
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.
Secondary Outcome Measure Information:
Title
Feasibility of Integrating EMAs into a Clinical Trial
Description
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).
Time Frame
The completion of the EMA surveys will be computed at the 6-months post-intervention timepoint.
Title
Change in the EMA Neurocognition performance from baseline to 1-week and 6-months post-intervention - Jewel task
Description
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.
Time Frame
Participants complete the Jewels task through the DigiSensing App at baseline, 1-week post-intervention, and 6-months post-intervention.
Title
Change in the EMA Community Functioning performance from baseline to 1-week and 6-months post-intervention ( Questionnaire about Process to Recovery).
Description
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.
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
Title
Change in the EMA Community Functioning performance from baseline to 1-week and 6-months post-intervention (Social Functioning Questionnaire).
Description
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.
Time Frame
Participants complete the Social Functioning Questionnaire through the DigiSensing app at baseline, 1-week post-intervention, and 6-months post-intervention.
Other Pre-specified Outcome Measures:
Title
Symptom Severity at baseline
Description
The investigators will measure symptom severity through the Positive and Negative Severity Scale. Each of the 30 items of the Positive and Negative Severity Scale is rated on a scale of 7 points and the total score ranges from 30 to 210, with higher scores indicating more severe psychotic disorder symptoms.
Time Frame
Participants complete the Positive and Negative Severity Scale at baseline.
Title
Change in Symptom Severity from baseline to 1-week post-intervention and 3-months post-intervention.
Description
The investigators will measure symptom severity through the brief version of the PANSS (PANSS-6). Each of the 6 items of the brief version of the Positive and Negative Severity Scale is rated on a scale of 7 points and the total score ranges from 6 to 42 with higher scores indicating more severe symptoms of a psychotic disorder.
Time Frame
Participants complete the brief version of the Positive and Negative Severity Scale at 1-week post-intervention and 3-months post-intervention.
Title
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.
Description
The investigators will measure subjective perceptions of neurocognitive functioning through the Subjective Scale to Investigate Cognition in Schizophrenia - Brief (SSTICS-Brief). Each of the 14 items are scored on a 5 points Likert-type scale that extends from 0 ("never") to 4 ("very often"). The total score ranges from 0 to 56 with higher score indicating a higher perceived difficulty in neurocognition.
Time Frame
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.
Title
Intrinsic Motivation
Description
The investigators will measure motivation through the Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR). The Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR) is rated on a 7-point Likert-type scale with responses ranging from 1 ("not at all true") to 7 ("very true"). The score ranges from 30 to 210 with higher scores indicating greater intrinsic motivation.
Time Frame
Participants complete the Intrinsic Motivation Inventory for Schizophrenia Research at baseline.]
Title
Motivation
Description
The investigators will measure motivation through the Basic Psychological Need Satisfaction and Frustration Scale. Each item is scored on a 5 points Likert-type scale that extends from 1 ("Not true at all") to 5 ("Completely true"). An overall composite score will be created, with scores ranging from 1 to 6. Higher scores indicate greater satisfaction of the psychological needs for autonomy, competence, and relatedness.
Time Frame
Participants complete the Basic Psychological Need Satisfaction and Frustration Scale at baseline.]
Title
Social Support (Friends)
Description
The investigators will measure perceived social support through the Perceived Social Support from Friends scale. Each of the 20 items has a maximum score of 1 ("yes", "no", and "don't know" response items). The scores range from 0 to 20 with higher scores indicating greater perceived social support from friends.
Time Frame
Participants complete the Perceived Social Support from Friends at baseline.
Title
Social Support (Family)
Description
The investigators will measure perceived social support through the Perceived Social Support from Family scale. Each of the 20 items has a maximum score of 1 ("yes", "no", and "don't know" response items). The scores range from 0 to 20 with higher scores indicating greater perceived social support from family.
Time Frame
Participants complete the Perceived Social Support from Family at baseline.
Title
Change in level of stress performance from baseline to 1-week and 3-months post-intervention (Perceived Stress Scale).
Description
The investigators will measure the level of stress through the Perceived Stress Scale. The Perceived Stress Scale is rated on a five-point scale from 0 ("never") to 4 ("very often"). Individual scores can range from 0 to 40 with higher scores indicating higher perceived stress.
Time Frame
Participants complete the Perceived Stress Scale at baseline, 1-week post-intervention, and 3-months post-intervention.
Title
Change in stress resilience performance from baseline to 1-week and 3-months post-intervention (Brief Resilience Scale).
Description
The investigators will measure stress resilience through the Brief Resilience Scale. The Brief Resilience Scale is rated on a scale from 1 ("low resilience") to 5 ("high resilience"). The total mean score ranges from 1 to 5 with a higher score indicating a higher resilience.
Time Frame
Participants complete the Brief Resilience Scale at baseline, 1-week post-intervention, and 3-months post-intervention.
Title
Affect
Description
The investigators will measure the level of affect arousal by creating a composite mean score reported on a core affect grid for each participant. The Core Affect Grid is composed with two dimensions measuring the level of arousal and pleasantness and is rated on a 5 points scale. A higher score indicates greater pleasure or arousal.
Time Frame
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
Title
Change in the Therapeutic Alliance from sixth intervention (3-weeks in the intervention) to 1-week post-intervention
Description
The investigators will measure the therapeutic alliance through the Work Alliance Inventory (WAI-S). The Work Alliance Inventory is rated on a 7-point Likert-type scale with responses ranging from 0 ("never") to 7 ("always"). The total score is from 7 to 84 with higher score indicating a greater work alliance.
Time Frame
Participants complete the Work Alliance Inventory Short version at the sixth intervention visit (3 weeks in the intervention) and 1-week post-intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Synthia Guimond, PhD
Phone
613-722-6521
Ext
6586
Email
synthia.guimond@theroyal.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Synthia Guimond, PhD
Organizational Affiliation
Royal Ottawa Mental Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Ottawa Mental Health Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 7K4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Synthia Guimond, PhD
Phone
613-722-6521
Ext
6586
Email
synthia.guimond@theroyal.ca

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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).
IPD Sharing Access Criteria
Upon request to Synthia Guimond
Citations:
PubMed Identifier
33857847
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.
Results Reference
background
Citation
National Institute of Mental Health (n.d.). Schizophrenia. https://www.nimh.nih.gov/health/topics/schizophrenia
Results Reference
background
PubMed Identifier
21377336
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.
Results Reference
background
PubMed Identifier
35179501
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.
Results Reference
background
PubMed Identifier
34934063
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.
Results Reference
background
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
Results Reference
background
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs