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Schizophrenia Spectrum DisordersNCT05784948

Safety and Efficacy of Virtual Reality Mindfulness in Patients With Psychosis

A study testing Virtual Reality Mindfulness Treatment and Experience relaxing scenery and music in people with Schizophrenia Spectrum Disorders and Schizophrenia, run by Chonbuk National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 15 to 59 yearsHealthy volunteers can take part
What is being tested?
Virtual Reality Mindfulness Treatment and Experience relaxing scenery and music
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
67 participants
Where
1 siteSouth Korea
Study dates
8 Apr 2020to 9 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

South Korea1 site
  • Department of Psychiatry, Chonbuk National University Hospital

    Jeonju, Jeollabuk-do, 54907

Other trials in South Korea

About this study

Official title: Efficacy of Virtual Reality Mindfulness in Patients With Psychosis

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

Read the 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.

Being tested
Virtual Reality Mindfulness Treatment, Experience relaxing scenery and music
Keywords
Virtual Reality Mindfulness
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality Mindfulness TreatmentOther

    once a week for 30 minutes, over 8 weeks

  • Experience relaxing scenery and musicOther

    once a week for 30 minutes, over 8 weeks

Study groups in NCT05784948
Study groupRoleWhat they receive
Virtual Reality Mindfulness TreatmentExperimentalExperience virtual reality mindfulness treatment with a screen from a head-mounted display for 30 minutes in a comfortable sitting position.
Receives: Other: Virtual Reality Mindfulness Treatment
Relaxing scenery and music experienceSham comparatorExperience relaxing scenery and music with a screen from a head-mounted display for 30 minutes in a comfortable sitting position.
Receives: Other: Experience relaxing scenery and music

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 week

Secondary outcomes (15)
  1. Efficacy Assessment by Psychotic Symptom Rating Scales (PSYRATS)

    Korean Psychotic Symptom Rating Scales-Delision (K-PSYRATS-D) is to assess whether the assessed individual is experiencing delusional symptoms. This subscale consists of 11 items, with a minimum score of 0 (none) and a maximum score of 4 (extremely severe). The total score for this subscale ranges from 0 to 44, with a minimum score of 0 and a maximum score of 44. The higher scores indicate more severe delusional symptoms.

    Measured: 1 week

  2. Efficacy Assessment by Psychotic Symptom Rating Scales (PSYRATS)

    Korean Psychotic Symptom Rating Scales-Auditory Hallucination (K-PSYRATS-AH) is used to assess the presence of hallucination symptoms in the individual being evaluated. This subscale consists of 11 items, with a minimum score of 0 (none) and a maximum score of 4 (extremely severe). Higher scores indicate more severe hallucination symptoms.

    Measured: 1 week

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

    Korea-PERS-I assesses the risk of developing psychosis based on six factors: paternal age at birth, parental socioeconomic status (SES), urbanicity, childhood trauma, adult life events, and clinical high-risk state for psychosis. Paternal age over 35 years is scored as 0.5 if exposed and -0.5 if not. Parental SES is scored as 1 if receiving medical aid and 0 if not. Urbanicity is scored as 0 for living in a city and -3 for not. Childhood trauma is scored as 4.5 if exposed and 0 if not. Adult life events are scored as 5.5 if exposed and -2 if not. Clinical high-risk state for psychosis is scored as 10 if exposed and 0 if not. The scores for all six factors are added up to obtain a total score, with higher scores indicating greater risk. Data will be collected twice, one week before and after the intervention.

    Measured: through study completion, an average of 8 weeks

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

    Korea-PERS-II assesses the risk of developing psychosis based on six factors: paternal age at birth, obstetric complications, parental SES, urbanicity, childhood adversity, and recent life events. Paternal age is scored based on age ranges, with scores ranging from 0 to 2. Obstetric complications are scored as 2 if birth weight is less than 2.5kg and 0 if not. Parental SES is scored based on income and education levels, with scores ranging from -1.5 to 3. Urbanicity is scored based on living location, with scores ranging from -2 to 0.5. Childhood adversity includes neglect, emotional abuse, physical abuse, and sexual abuse, with scores ranging from 0 to 5.5. Sexual abuse with moderate levels is scored as 4 if exposed and 0 if not. Recent life events are scored as 3 if exposed and -2 if not. The scores for all six factors are added up to obtain a total score, with higher scores indicating greater risk. Data will be collected twice, one week before and after the intervention.

    Measured: through study completion, an average of 8 weeks

  5. Efficacy Assessment by Positive and Negative Syndrome Scale

    Positive and Negative Syndrome Scale (PANSS) is a scale used to assess the severity of positive, negative, and cognitive symptoms in patients with psychotic disorders, minimum of each item (Positive Scale, Negative Scale and General Psychopathology Scale) is 1, maximum is 7. The higher number is worse outcome. The data will be taken twice, i.e., within one-week before and after the intervention.

    Measured: 1 week

  6. Efficacy Assessment by Social and Occupational Functioning Assessment Scale

    Social and Occupational Functioning Assessment Scale (SOFAS) consists of ranging from 100 points (excellent functioning) to 0 points (grossly impaired functioning). The specific rating criteria for SOFAS are as follows: Self-care, Social functioning, Occupational functioning, Educational functioning, Leisure functioning. The higher scores indicating higher levels of functioning. The data will be taken twice within one-week before and after the intervention.

    Measured: 1 week

  7. Efficacy Assessment by Health of the Nation Outcome Scales

    Health of the Nation Outcome Scales (HoNOS) is a scale used to assess the mental health and social functioning of patients. It consists of 12 items, minimum of each item is 0, maximum is 4. The higher scores indicate more severe patient conditions. The data will be taken twice within one-week before and after the intervention.

    Measured: 1 week

  8. Efficacy Assessment by Columbia-Suicide Severity Rating Scale

    Columbia-Suicide Severity Rating Scale (C-SSRS) is a scale used to assess suicide risk. It includes 9 items, minimum of each item is 0, maximum is 4. The higher scores indicating greater risk. The data will be taken twice within one-week before and after the intervention.

    Measured: 1 week

  9. Safety Assessment by Skin conductance level

    Skin conductance level (SCL) results are typically expressed in microsiemens (μS), which is the unit of electrical conductivity. The range of skin conductance level values is usually 0.5~50 μS, under conditions of emotional excitement, anxiety, and tension, leading to an increase in skin conductance level.

    Measured: 1 week

  10. Safety Assessment by Heart rate

    Heart rate (HR) is the number of times the heart beats per minute and is typically measured in beats per minute (bpm). The resting heart rate for adults is generally between 60-100 bpm. A higher heart rate typically indicates that the heart needs to beat faster to meet the body's needs, which may be caused by factors such as emotional excitement, exercise, stress, pain, or illness.

    Measured: 1 week

  11. Safety Assessment by R-R interval

    The R-R interval is the time interval between adjacent R waves on an electrocardiogram (ECG) and is typically measured in seconds. The normal range of the R-R interval is usually between 0.6-1.2 seconds. A higher RR interval typically indicates an abnormal heart rhythm or some form of heart problem.

    Measured: 1 week

  12. Efficacy Assessment by self rating scale Perceived Stress Scale (PSS)

    The Perceived Stress Scale (PSS) consists of 10 items, with each item rated on a 5-point scale ranging from 0 (never) to 4 (very often). The minimum score on the scale is 0, and the maximum score is 40. The higher scores on the PSS indicate higher levels of perceived stress. The data will be taken twice within one-week before and after the intervention.

    Measured: 1 week

  13. Efficacy Assessment by self rating scale Subjective Wellbeing under Neuroleptics(SWN-K)

    Subjective Wellbeing under Neuroleptics (SWN-K) consists of 20 questions. The minimum score for each question is zero and the maximum score is five. The reverse scoring questions include 1,4,6,9,10,11,12,14,16,17. The total score of the whole item is obtained, and the lower the score, the worse the subjective well-being. The data will be taken twice within one-week before and after the intervention.

    Measured: 1 week

  14. Efficacy Assessment by self rating scale Motivation and Pleasure Scale-Self Report (MPS-SR)

    The Motivation and Pleasure Scale-Self Report (MPS-SR) consists of 14 questions, each rated on a 10-point scale, where the minimum and maximum scores for each item are 0 and 10, respectively, with higher scores indicating greater levels of motivation and pleasure. The data will be taken twice within one-week before and after the intervention.

    Measured: 1 week

  15. Efficacy Assessment by self rating scale Beck Depression Inventory (BDI)

    Beck Depression Inventory (BDI) consists of 21 items including cognitive, emotional, synchronous, and physical symptoms of depression. The total score ranges from 0~63 points for each question. Its score is 0 ~ 9 points non-depression, 10 ~ 15 is mild depression, 16 ~ 23 is moderate depression, and 24 ~ 63 is severe depression. The data will be taken twice within one-week before and after the intervention.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2023
  2. Study start8 Apr 2020
  3. Primary completion9 Jun 2021
  4. Study completion9 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05784948
Sponsor's protocol ID
2020-01-042
Status last verified
Apr 2023
First submitted
8 Feb 2023
Last updated
10 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality Mindfulness Treatment and Experience relaxing scenery and music in people with Schizophrenia Spectrum Disorders and Schizophrenia, run by Chonbuk National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Assessment by Experience Questionnaire Decentering (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.

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