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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
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.
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.
Royal Ottawa Mental Health Centre
Ottawa, Ontario, Canada
RECRUITINGFeasibility 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.
Time frame: 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.
Time frame: 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.
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.
Acceptability of the intervention
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.
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.
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.
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).
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).
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.
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.
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).
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.]
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.
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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).
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.
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.
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).
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
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.
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
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.
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.
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).
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.