Clinical trial NCT05784948: Safety and Efficacy of Virtual Reality Mindfulness in Patients With Psychosis
Official title: Efficacy of Virtual Reality Mindfulness in Patients With Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia Spectrum Disorders
Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorders
Psychotic Disorder Not Otherwise Specified
Keywords: Virtual Reality Mindfulness
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 67
Sex: ALL
Minimum age (years): 15
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Efficacy Assessment by Experience Questionnaire Decentering
timeFrame: 1 week
Secondary outcomes:
measure: Efficacy Assessment by Psychotic Symptom Rating Scales (PSYRATS)
timeFrame: 1 week
measure: Efficacy Assessment by Psychotic Symptom Rating Scales (PSYRATS)
timeFrame: 1 week
measure: Efficacy Assessment by Korea-Polyenvironmental Risk Score-I (PERS-I)
timeFrame: through study completion, an average of 8 weeks
measure: Efficacy Assessment by Korea-Polyenvironmental Risk Score-II (PERS-II)
timeFrame: through study completion, an average of 8 weeks
measure: Efficacy Assessment by Positive and Negative Syndrome Scale
timeFrame: 1 week
measure: Efficacy Assessment by Social and Occupational Functioning Assessment Scale
timeFrame: 1 week
measure: Efficacy Assessment by Health of the Nation Outcome Scales
timeFrame: 1 week
measure: Efficacy Assessment by Columbia-Suicide Severity Rating Scale
timeFrame: 1 week
measure: Safety Assessment by Skin conductance level
timeFrame: 1 week
measure: Safety Assessment by Heart rate
timeFrame: 1 week
measure: Safety Assessment by R-R interval
timeFrame: 1 week
measure: Efficacy Assessment by self rating scale Perceived Stress Scale (PSS)
timeFrame: 1 week
measure: Efficacy Assessment by self rating scale Subjective Wellbeing under Neuroleptics(SWN-K)
timeFrame: 1 week
measure: Efficacy Assessment by self rating scale Motivation and Pleasure Scale-Self Report (MPS-SR)
timeFrame: 1 week
measure: Efficacy Assessment by self rating scale Beck Depression Inventory (BDI)
timeFrame: 1 week
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Department of Psychiatry, Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
affiliation: Chonbuk National University Hospital
name: Young-chul Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: