Safety and Efficacy of Virtual Reality Mindfulness in Patients With Psychosis

Chonbuk National University

Status: Completed

Conditions: Schizophreniform Disorders; Schizophrenia; Schizophrenia Spectrum Disorders; Schizoaffective Disorder; Psychotic Disorder Not Otherwise Specified

Treatments: Other: Virtual Reality Mindfulness Treatment; Other: Experience relaxing scenery and music

Study type: Interventional

Funder types: Other

Identifiers

NCT05784948

2020-01-042

Details and patient eligibility

About

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

Full description

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.

Enrollment: 67 patients

Sex: All

Ages: 15 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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67 participants in 2 patient groups

Virtual Reality Mindfulness Treatment

Experimental group

Description:

Experience virtual reality mindfulness treatment with a screen from a head-mounted display for 30 minutes in a comfortable sitting position.

Treatment:

Other: Virtual Reality Mindfulness Treatment

Relaxing scenery and music experience

Sham Comparator group

Description:

Experience relaxing scenery and music with a screen from a head-mounted display for 30 minutes in a comfortable sitting position.

Treatment:

Other: Experience relaxing scenery and music