Safety and Efficacy of Virtual Reality Mindfulness in Patients With Psychosis

NCT ID: NCT05784948

Last Updated: 2023-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-08

Study Completion Date

2021-06-09

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Virtual Reality Mindfulness Treatment

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

Group Type EXPERIMENTAL

Virtual Reality Mindfulness Treatment

Intervention Type OTHER

once a week for 30 minutes, over 8 weeks

Relaxing scenery and music experience

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

Group Type SHAM_COMPARATOR

Experience relaxing scenery and music

Intervention Type OTHER

once a week for 30 minutes, over 8 weeks

Interventions

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Virtual Reality Mindfulness Treatment

once a week for 30 minutes, over 8 weeks

Intervention Type OTHER

Experience relaxing scenery and music

once a week for 30 minutes, over 8 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Chul Chung

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-chul Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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Department of Psychiatry, Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2020-01-042

Identifier Type: -

Identifier Source: org_study_id

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