Safety and Efficacy of Virtual Reality Mindfulness in Patients With Psychosis

Efficacy of Virtual Reality Mindfulness in Patients With Psychosis

This study is to evaluate the safety and efficacy of Virtual Reality Mindfulness in Patients With Psychosis.

This study is randomized, single-blind and parallel group trial to evaluate the safety and the efficacy of Virtual Reality Mindfulness in Patients With Psychosis once a week over 8 weeks treatment period. Both groups can experience the screen coming out of the head-mounted display for 30 minutes in a comfortable sitting position.

Inclusion Criteria:

• Male or female patients who are 15-59 years (inclusive) of age at time of consent.
• Patients with current DSM-5 (Diagnostic and Statistical Manual of Mental Disorders-fifth edition) diagnosis schizophrenia spectrum and other psychotic disorders including bipolar and related disorders or depressive disorder with psychotic symptoms.
• Patients who can agree to participate in the study in a stable state (Clinical Global Impression score of 5 or less) and cooperate appropriately with questionnaires and tests.
• Patients with a SOFAS score in the range of 41 to 80 points.
• Patients with a PANSS score of less than 85 points.

Exclusion Criteria:

• Patients who are currently in poor health due to serious physical illness
• Patients who are currently pregnant or lactating.
• Patients who are accompanying intellectual disability with an Intelligence Quotient (IQ) of 70 or lower
• Patients who have difficulty in agreeing to and participating in research due to severely impaired ability to verify reality
• Patients with a PANSS score of 85 or higher or a CGI of 6 or higher
• Patients with a SOFAS score of 40 or less or 81 or more
• Patients who are currently in hospitalized