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.
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
- Conditions the study is for
- Schizophrenia Spectrum Disorders, Schizophrenia, Schizoaffective Disorder
- 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
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.
- Conditions
- Schizophrenia Spectrum Disorders, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Psychotic Disorder Not Otherwise Specified
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Experience relaxing scenery and music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted27 Mar 2023
- Study start8 Apr 2020
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia Spectrum DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Chul Chung, Chonbuk National University Hospital
- Investigators
- Young-chul Chung, MD, Principal investigator, Chonbuk National University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality Mindfulness in Patients With Psychosis
- ClinicalTrials.gov ID
- NCT05784948
- Acronym / sponsor ID
- 2020-01-042
- Conditions
- Schizophrenia Spectrum Disorders, Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorders, Psychotic Disorder Not Otherwise Specified
- Keywords
- Virtual Reality Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Mindfulness Treatment | Experimental | Other: Virtual Reality Mindfulness TreatmentExperience virtual reality mindfulness treatment with a screen from a head-mounted display for 30 minutes in a comfortable sitting position. |
| Relaxing scenery and music experience | Sham comparator | Other: Experience relaxing scenery and musicExperience relaxing scenery and music with a screen from a head-mounted display for 30 minutes in a comfortable sitting position. |
Who may qualify
- Ages
- 15 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Mindfulness Treatmentonce a week for 30 minutes, over 8 weeks | Other | Virtual Reality Mindfulness Treatment |
| Experience relaxing scenery and musiconce a week for 30 minutes, over 8 weeks | Other | Relaxing scenery and music experience |
Primary outcome
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.
15 secondary outcomes
Efficacy Assessment by Psychotic Symptom Rating Scales (PSYRATS)
Time frame: 1 week
Efficacy Assessment by Psychotic Symptom Rating Scales (PSYRATS)
Time frame: 1 week
Efficacy Assessment by Korea-Polyenvironmental Risk Score-I (PERS-I)
Time frame: through study completion, an average of 8 weeks
Efficacy Assessment by Korea-Polyenvironmental Risk Score-II (PERS-II)
Time frame: through study completion, an average of 8 weeks
Efficacy Assessment by Positive and Negative Syndrome Scale
Time frame: 1 week
Efficacy Assessment by Social and Occupational Functioning Assessment Scale
Time frame: 1 week
Efficacy Assessment by Health of the Nation Outcome Scales
Time frame: 1 week
Efficacy Assessment by Columbia-Suicide Severity Rating Scale
Time frame: 1 week
Safety Assessment by Skin conductance level
Time frame: 1 week
Safety Assessment by Heart rate
Time frame: 1 week
Safety Assessment by R-R interval
Time frame: 1 week
Efficacy Assessment by self rating scale Perceived Stress Scale (PSS)
Time frame: 1 week
Efficacy Assessment by self rating scale Subjective Wellbeing under Neuroleptics(SWN-K)
Time frame: 1 week
Efficacy Assessment by self rating scale Motivation and Pleasure Scale-Self Report (MPS-SR)
Time frame: 1 week
Efficacy Assessment by self rating scale Beck Depression Inventory (BDI)
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-chul Chung, MD principal investigator
Chonbuk National University Hospital
1 site in 1 country: see every site and its status.
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.