Safety and Efficacy of virtual reality therapy for idea of reference in patients with psychosis and verification of changes in brain connectivity with fMRI

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0007710

Enrollment

Registered

2022-09-16

Start date

2022-08-04

Completion date

Unknown

Last updated

2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : VR is performed 10 times at 30-minute intervals per week for 1 week. For each session, they will receive an assigned program after listening to a separately produced training video. a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: A person who agrees to participate in the research and who can properly cooperate with and conduct questionnaires and tests Those with a PANSS score of less than 85

Exclusion criteria

Exclusion criteria: ?Currently due to a serious physical disease (a person with a history of head injury, a neurological disease [epileptic, stroke, Parkinson's disease, dementia, etc.] ?If they are pregnant or lactating ?In case of accompanying intellectual disability of IQ 70 or lower ?Those who have difficulty in consenting and participating in research due to severe impairment of reality verification power ?CGI score of 6 or higher, PANSS score of 85 or higher, or N1 or N4 score of 5 or higher ?People who are not suitable for MRI scans (patients with claustrophobia, artificial pacemakers, blood sugar controllers, patients with attached or possessed metal materials or inserted into the body, etc.)

Design outcomes

Primary

Measure	Time frame
- Demographic information and clinical data ?Age, gender, education, occupation, marital status, height, weight, physical illness, smoking/drinking level ?Untreated psychotic period (DUP), morbidity period, treatment period, hospitalization history, suicide attempt experience, medication, drug information (drug content, drug naïve or free status evaluation), community services provided, family history of mental illness , physical disease and treatment - Objective clinical evaluation (40 minutes) ?Psychopathology: Positive and Negative Syndrome Scale (PANSS, Kay et al 1987), PSYRATS-Delusion & Auditory hallucinations, Clinical Global Impression, CGI) (Guy 1976) ?Functional Assessment: Social and Occupational Functioning Assessment Scale (SOFAS, Goldman et al 1992) - Self-evaluation scale (20 minutes): Investigate factors related to related accidents (figure) ?Revised Green et al Paranoid Thought Scales (R-GPTS) (Freeman et al 2019): Consists of 8 items measuring relational thinking and 10 items measuring relational delusions ?Brief version of the fear of negative evaluation scale (BFNE) (Leary 1983): 12 items ?Broading scale (BS) (Kim et al 2019) ?Internal, personal and situational attribution questionnaire (IPSAQ) (Bentall et al 1991) ?Rosenberg self esteem scale (Rosenberg 1965) ?Beck Depression Inventory (BDI) ?State-Trait Anger Expression questionnaire (STAXI) (Spielberger 1988) ?Brief core schema scale (BCSS) (Fowler et al 2006) ?Childhood Trauma Questionnaire (CTQ) (Bernstein et al 2003): 28 questions	—

Measure

Time frame

- Demographic information and clinical data ?Age, gender, education, occupation, marital status, height, weight, physical illness, smoking/drinking level ?Untreated psychotic period (DUP), morbidity period, treatment period, hospitalization history, suicide attempt experience, medication, drug information (drug content, drug naïve or free status evaluation), community services provided, family history of mental illness , physical disease and treatment - Objective clinical evaluation (40 minutes) ?Psychopathology: Positive and Negative Syndrome Scale (PANSS, Kay et al 1987), PSYRATS-Delusion & Auditory hallucinations, Clinical Global Impression, CGI) (Guy 1976) ?Functional Assessment: Social and Occupational Functioning Assessment Scale (SOFAS, Goldman et al 1992) - Self-evaluation scale (20 minutes): Investigate factors related to related accidents (figure) ?Revised Green et al Paranoid Thought Scales (R-GPTS) (Freeman et al 2019): Consists of 8 items measuring relational thinking and 10 items measuring relational delusions ?Brief version of the fear of negative evaluation scale (BFNE) (Leary 1983): 12 items ?Broading scale (BS) (Kim et al 2019) ?Internal, personal and situational attribution questionnaire (IPSAQ) (Bentall et al 1991) ?Rosenberg self esteem scale (Rosenberg 1965) ?Beck Depression Inventory (BDI) ?State-Trait Anger Expression questionnaire (STAXI) (Spielberger 1988) ?Brief core schema scale (BCSS) (Fowler et al 2006) ?Childhood Trauma Questionnaire (CTQ) (Bernstein et al 2003): 28 questions

—

Countries

Korea, Republic of

Contacts

Public ContactYoung-chul Chung

Jeonbuk National University Hospital

chungyc@jbnu.ac.kr+82-63-259-2185

Outcome results