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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Cognitive Remediation
  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.
• Поведенческое Active Control
  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.

Первичные конечные точки

• Feasibility of the Intervention (attrition rate). [Срок оценки: The training completion will be computed at the 1-week post-intervention timepoint.]
• Feasibility of the intervention (homework completion). [Срок оценки: Homework completion will be computed at the 1-week post-intervention timepoint.]
• Feasibility of the intervention (cybersickness). [Срок оценки: 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 [Срок оценки: 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. [Срок оценки: The Treatment Acceptability/Adherence Scale will be administered at the sixth intervention visit (3 weeks in the intervention) and 1-week post-intervention.]

Вторичные конечные точки (12)

• Feasibility of Integrating EMAs into a Clinical Trial [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: 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 [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: Participants complete the Social Functioning Questionnaire through the DigiSensing app at baseline, 1-week post-intervention, and 6-months post-intervention.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• Royal Ottawa Mental Health Centre — Ottawa

Публикации

• 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. PMID 33857847
• National Institute of Mental Health (n.d.). Schizophrenia. https://www.nimh.nih.gov/health/topics/schizophrenia
• 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. PMID 21377336
• 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. PMID 35179501
• 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. PMID 34934063
• 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
• 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 pr

Идентификаторы

NCT: NCT05973110 · 2023001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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