Examining the Efficacy of a Virtual Reality Cognitive Remediation Program for People Living With Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in the community functioning performance from baseline to 1-week and 3-months post-intervention (Role Functioning Scale).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cognitive Remediation
干预措施: Cognitive Remediation (Behavioral)
Active Control
干预措施: Active Control (Behavioral)
结局指标
主要结局
Change in the community functioning performance from baseline to 1-week and 3-months post-intervention (Role Functioning Scale).
时间窗: Participants complete the Role Functioning Scale at baseline, 1-week post-intervention, and 3-months post-intervention.
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.
Change in social-cognitive performance from baseline to 1-week and 3-months post-intervention (PENN emotion recognition task).
时间窗: Time Frame: Participants complete the PENN emotion recognition task at baseline, 1-week post-intervention, and 3-months post-intervention
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 neurocognitive performance from baseline to 1-week and 3-months post- intervention (Cambridge Automated Neuropsychology Battery).
时间窗: Participants complete the Cambridge Automated Neuropsychology Battery at baseline, 1-week post-intervention, and 3-months post-intervention
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 cognition performance from baseline to 1-week and 3-months post-intervention (Ambiguous Intentions Hostility Questionnaire).
时间窗: Participants complete the Ambiguous Intentions Hostility Questionnaire at baseline, 1-week post-intervention, and 3-months post-intervention
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 (The Hinting Task).
时间窗: Participants complete the Hinting Task test at baseline, 1-week post-intervention, and 3 months post-intervention
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.
Feasibility of the Intervention (attrition rate).
时间窗: The training completion will be computed at the 1-week post-intervention timepoint.
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).
时间窗: Homework completion will be computed at the 1-week post-intervention timepoint.
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.
Change in social cognition performance from baseline to 1-week and 3-months post-intervention (Emotion Regulation Questionnaire).
时间窗: Participants complete the Emotion Regulation Questionnaire test at baseline, 1-week post-intervention, and 3-months post-intervention.
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 the community functioning performance from baseline to 1-week and 3-months post-intervention (UCSD performance-based skills assessment brief).
时间窗: Participants complete the measure at baseline, 1-week post-intervention, and 3 months post-intervention.]
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).
时间窗: Participants complete the modified Global Assessment of Functioning at baseline, 1-week post-intervention, and 3-months post-intervention
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.
Feasibility of the intervention (cybersickness).
时间窗: 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.
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
时间窗: The satisfaction questionnaire will be administered at the 1-week post-intervention time point.
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.
时间窗: The Treatment Acceptability/Adherence Scale will be administered at the sixth intervention visit (3 weeks in the intervention) and 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.
次要结局
- 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 EMA Neurocognition performance from baseline to 1-week and 6-months post-intervention - Jewel task(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).(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).(Participants complete the Social Functioning Questionnaire through the DigiSensing app at baseline, 1-week post-intervention, and 6-months post-intervention.)
- 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)
- Change in social cognition performance from baseline to 1-week and 3-months post-intervention (Emotion Regulation Questionnaire).(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).(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).(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).(Participants complete the Cambridge Automated Neuropsychology Battery at baseline, 1-week post-intervention, and 3-months post-intervention)
研究者
Synthia Guimond
Scientist
The Royal Ottawa Mental Health Centre