Safety and Efficacy of Virtual Reality Mindfulness in Patients With Psychosis

Sponsor
Chonbuk National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05784948
Collaborator
(none)
67
1
2
14
4.8

Study Details

Study Description

Brief Summary

This study is to evaluate the safety and the efficacy of Virtual Reality Mindfulness in Patients With Psychosis and Verification of Changes in Brain Connectivity With fMRI.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual Reality Mindfulness Treatment
  • Other: Experience relaxing scenery and music
N/A

Detailed Description

This study is randomized, double-blind and parallel group trial to evaluate the safety and the efficacy of Virtual Reality Mindfulness and Verification of Changes in Brain Connectivity With fMRI 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 16 minutes in a comfortable sitting position.

Study Design

Study Type:
Interventional
Actual Enrollment :
67 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Efficacy of Virtual Reality Mindfulness in Patients With Psychosis and Verification of Changes in Brain Connectivity With fMRI
Actual Study Start Date :
Apr 8, 2020
Actual Primary Completion Date :
Jun 9, 2021
Actual Study Completion Date :
Jun 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual Reality Mindfulness Treatment

Experience virtual reality mindfulness treatment with a screen from a head-mounted display for 16 minutes in a comfortable sitting position.

Other: Virtual Reality Mindfulness Treatment
once a week for 16 minutes, over 8 weeks

Sham Comparator: Relaxing scenery and music experience

Experience relaxing scenery and music with a screen from a head-mounted display for 16 minutes in a comfortable sitting position.

Other: Experience relaxing scenery and music
once a week for 16 minutes, over 8 weeks

Outcome Measures

Primary Outcome Measures

  1. Efficacy Assessment by Korea-Polyenvironmental Risk Score-I (PERS-I) [through study completion, an average of 8 weeks]

    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.

  2. Efficacy Assessment by Korea-Polyenvironmental Risk Score-II (PERS-II) [through study completion, an average of 8 weeks]

    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.

  3. Efficacy Assessment by Positive and Negative Syndrome Scale [1 week]

    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.

  4. Efficacy Assessment by Social and Occupational Functioning Assessment Scale [1 week]

    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.

  5. Efficacy Assessment by Health of the Nation Outcome Scales [1 week]

    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.

  6. Efficacy Assessment by Columbia-Suicide Severity Rating Scale [1 week]

    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.

  7. Safety Assessment by Skin conductance level [1 week]

    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.

  8. Safety Assessment by Heart rate [1 week]

    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.

  9. Safety Assessment by R-R interval [1 week]

    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.

  10. Efficacy Assessment by self rating scale Perceived Stress Scale (PSS) [1 week]

    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.

  11. Efficacy Assessment by self rating scale Subjective Wellbeing under Neuroleptics(SWN-K) [1 week]

    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.

  12. Efficacy Assessment by self rating scale Motivation and Pleasure Scale-Self Report (MPS-SR) [1 week]

    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.

  13. Efficacy Assessment by self rating scale Beck Depression Inventory (BDI) [1 week]

    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.

  14. Structural brain imaging (structural magnetic resonance imaging, sMRI) [1 week]

    In the sMRI study, measuring volume (mm), thickness (mm), and area ( 〖mm〗^2) of cortical and subcortical to define the abnormalities of brain anatomical structures and pathology of the brain. The Freesurfer is the main toolbox for fMRI analysis. sMRI data acquisition: Three-dimensional T1-weighted images were obtained using magnetization-prepared rapid gradient echo (repetition time:1,900 ms, echo time: 2.5 ms; flip angle: 9°, field of view: 250 mm2; image matrix: 256 × 246 mm; voxel size = 1.0 × 1.0 × 1.0 mm3;176 slices) at Jeonbuk National University Hospital on a 3T Verioscanner (Siemens Magnetom Verio, Erlangen, Germany) using a 12-channel standard quadrature head coil.

  15. Functional brain imaging (functional magnetic resonance imaging, fMRI) [1 week]

    Task-based fMRI measures BOLD signal changes during cognitive tasks compared to control states. In this study, participants underwent five fMRI sessions: baseline resting-state, first task, resting-state after first task, second task, and resting-state after second task. Two 5-minute tasks were used to induce feelings of anger and gratitude, and participants followed audio-visual instructions presented in a black and white format. The first minute of each task involved deep breathing for relaxation. During the anger-inducing task, participants focused on negative events or mistakes that made them feel self-reproach or anger for the next 4 minutes. During the gratitude-inducing task, participants focused on a mental image of their mother or someone they feel grateful for, and the audio-visual instructions prompted them to express appreciation to that person in their mind.

  16. Functional brain imaging (functional magnetic resonance imaging, fMRI) [1 week]

    In the resting state-fMRI, all participants are instructed to lie still while resting with their eyes closed and are forbidden to think of anything. The rs-fMRI measures spontaneous low-frequency fluctuations in the BOLD signal to investigate the functional architecture of the brain. Applications of this technique allow the identification of various brain activities. For example: Whole brain functional connectivity analysis mainly focus on hypo and hyper connectivity (CONN toolbox). Sparse functional connectivity topological graph theory analysis considers about path of information flows and importance of brain regions (GRETNA toolbox). fMRI data acquisition: When collecting 8-min resting state that was obtained using a gradient-echo echo-planar imaging sequence with parameters of TR/TE = 2,000/30 ms, flip angle = 90°, FOV = 240 mm × 240 mm, data matrix = 64 × 64, voxel size = 1.0 × 1.0 × 1.0 mm3; 240 volumes were acquired.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 59 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

  • Patients who are not suitable for MRI (claustrophobic patients, pacemakers, blood sugar regulators, patients who have attached, possessed, or inserted metal substances into the body, etc.)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Psychiatry, Chonbuk National University Hospital Jeonju Jeollabuk-do Korea, Republic of 54907

Sponsors and Collaborators

  • Chonbuk National University Hospital

Investigators

  • Principal Investigator: Young-chul Chung, MD, Chonbuk National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Young Chul Chung, Professor of Psychiatry, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT05784948
Other Study ID Numbers:
  • 2020-01-042
First Posted:
Mar 27, 2023
Last Update Posted:
Mar 27, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Young Chul Chung, Professor of Psychiatry, Chonbuk National University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 27, 2023