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

Study Overview
=================
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.

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

Conditions
-----------------
Psychotic Disorders, Schizophrenia, Schizo Affective Disorder

Intervention / Treatment
-----------------
* Behavioral: Cognitive Remediation
* Behavioral: Active Control


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Remediation<br> | Behavioral: Cognitive Remediation<br>* 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.<br>|
| Active Comparator: Active Control<br> | Behavioral: Active Control<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Participants complete the Cambridge Automated Neuropsychology Battery 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: Participants complete the PENN emotion recognition task 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. | Participants complete the Ambiguous Intentions Hostility Questionnaire 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. | 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 (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. | Participants complete the Hinting Task test 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. | Participants complete the measure 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. | 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 (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. | Participants complete the Role Functioning Scale at baseline, 1-week post-intervention, and 3-months post-intervention. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | The completion of the EMA surveys will be computed at the 6-months post-intervention timepoint. | 
| 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. | 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. | 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. | Participants complete the Social Functioning Questionnaire through the DigiSensing app at baseline, 1-week post-intervention, and 6-months post-intervention. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychotic Disorders, Cognitive Remediation, Virtual Reality, Neurocognition, Social Cognition, Community Functioning