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

The Royal Ottawa Mental Health Centre

Status

Enrolling

Conditions

Psychotic Disorders

Schizophrenia

Schizo Affective Disorder

Treatments

Behavioral: Active Control

Behavioral: Cognitive Remediation

Study type

Interventional

Funder types

Other

Identifiers

NCT05973110

2023001

Details and patient eligibility

About

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.

Full 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.

Enrollment

52 estimated patients

Sex

All

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

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