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

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

Recruiting
20-55 years
All
Phase N/A

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Overview

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.

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.

Eligibility

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

Study details
    Psychotic Disorders
    Schizophrenia
    Schizo Affective Disorder

NCT05973110

The Royal Ottawa Mental Health Centre

26 January 2024

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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