Efficacy of Virtual Reality Mindfulness in Patients With Psychosis

Chonbuk National University Hospital1 site in 1 country67 target enrollmentApril 8, 2020

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Schizophrenia
Sponsor: Chonbuk National University Hospital
Enrollment: 67
Locations: 1
Primary Endpoint: Efficacy Assessment by Experience Questionnaire Decentering
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed 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.

Registry

clinicaltrials.gov

Start Date

April 8, 2020

End Date

June 9, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chonbuk National University Hospital

Responsible Party

Principal Investigator

Young Chul Chung

Professor of Psychiatry

Chonbuk National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Efficacy Assessment by Experience Questionnaire Decentering

Time Frame: 1 week

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.

Secondary Outcomes

Efficacy Assessment by Korea-Polyenvironmental Risk Score-I (PERS-I)(through study completion, an average of 8 weeks)
Efficacy Assessment by Columbia-Suicide Severity Rating Scale(1 week)
Efficacy Assessment by Psychotic Symptom Rating Scales (PSYRATS)(1 week)
Efficacy Assessment by Health of the Nation Outcome Scales(1 week)
Safety Assessment by Skin conductance level(1 week)
Safety Assessment by Heart rate(1 week)
Efficacy Assessment by self rating scale Perceived Stress Scale (PSS)(1 week)
Efficacy Assessment by Korea-Polyenvironmental Risk Score-II (PERS-II)(through study completion, an average of 8 weeks)
Efficacy Assessment by Social and Occupational Functioning Assessment Scale(1 week)
Safety Assessment by R-R interval(1 week)
Efficacy Assessment by self rating scale Subjective Wellbeing under Neuroleptics(SWN-K)(1 week)
Efficacy Assessment by Positive and Negative Syndrome Scale(1 week)
Efficacy Assessment by self rating scale Motivation and Pleasure Scale-Self Report (MPS-SR)(1 week)
Efficacy Assessment by self rating scale Beck Depression Inventory (BDI)(1 week)