Safety and Efficacy of Virtual Reality Mindfulness in Patients With Psychosis

NCT05784948 | Completed

• 1 other identifier: 2020-01-042
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Virtual Reality Mindfulness

Outcome Measures

Primary Outcomes (1)

• Efficacy Assessment by Experience Questionnaire Decentering

  The experience questionnaire (EQ) is a psychological measure used to assess attentional bias. The questionnaire consists of 15 items, with a minimum score of 1 and a maximum score of 7. The higher scores indicate the better outcome.

  1 week

Secondary Outcomes (15)

• Efficacy Assessment by Psychotic Symptom Rating Scales (PSYRATS)

  1 week

• Efficacy Assessment by Psychotic Symptom Rating Scales (PSYRATS)

  1 week

• Efficacy Assessment by Korea-Polyenvironmental Risk Score-I (PERS-I)

  through study completion, an average of 8 weeks

• Efficacy Assessment by Korea-Polyenvironmental Risk Score-II (PERS-II)

  through study completion, an average of 8 weeks

• Efficacy Assessment by Positive and Negative Syndrome Scale

  1 week

Study Arms (2)

Virtual Reality Mindfulness Treatment

EXPERIMENTAL

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

Other: Virtual Reality Mindfulness Treatment

Relaxing scenery and music experience

SHAM COMPARATOR

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

Other: Experience relaxing scenery and music

Interventions

Virtual Reality Mindfulness Treatment OTHER

once a week for 30 minutes, over 8 weeks

Virtual Reality Mindfulness Treatment

Experience relaxing scenery and music OTHER

once a week for 30 minutes, over 8 weeks

Relaxing scenery and music experience

Eligibility Criteria

• Age: 15 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Department of Psychiatry, Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 54907, South Korea

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Young-chul Chung, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 27, 2023
• Study Start: April 8, 2020
• Primary Completion: June 9, 2021
• Study Completion: June 9, 2021
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

KR (1)