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临床试验/NCT07326618
NCT07326618已完成不适用

The Use of Virtual Reality Application in Improving Psychosocial Dysfunction in Schizophrenia

Dokuz Eylul University2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2023年4月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
2
主要终点
Psychososcial Functioning

研究概览

简要总结

Virtual reality (VR) is a novel and innovative intervention method increasingly used in psychiatric research and treatment. VR allows individuals to experience realistic, everyday social situations in a safe and controlled environment. This study aims to examine the effects of a cinematic VR-based psychosocial intervention on individuals with schizophrenia who experience reduced psychosocial functioning and social isolation.

In this study, a Cinematic Virtual Reality Treatment Program (cVR-PTP) consisting of 12 weekly sessions was developed. Each session focuses on real-life social situations designed to support social interaction and daily functioning. The intervention aims to contribute to improvements in psychosocial functioning, social engagement, and overall functioning in individuals with schizophrenia.

详细描述

Schizophrenia is a severe mental disorder associated with significant impairments in psychosocial functioning. These impairments affect individuals' abilities to perform in daily life activities, maintain occupational functioning, and participate actively in social communities. Reduced psychosocial functioning is a major contributor to long-term disability in schizophrenia and is widely accepted as a core indicator of recovery beyond symptom remission.

Although antipsychotic medications are effective to a certain point in reducing positive symptoms, there is currently no pharmacological treatment that directly targets improvements in psychosocial functioning. For this reason, psychosocial interventions such as social skills training and social cognitive remediation programs have been developed to enhance social participation and functional outcomes in individuals with schizophrenia. However, these approaches often show limited effectiveness, and their benefits may not generalize to real-life situations or be equally effective for all patients.

Virtual reality (VR) has emerged as a promising alternative approach for psychosocial interventions in schizophrenia after the advances in technology. VR-based interventions allow individuals to engage in simulated social environments that offer ecological validity while maintaining a safe and controlled setting under the supervision of a mental health professional. Existing VR studies in schizophrenia have primarily based on computer-generated virtual environments or avatar-based characters.

In the present study, a cinematic virtual reality intervention program was created using 360-degree real world video recordings. This environmental seeting was designed to enhance immersion by presenting social situations as they naturally occur in everyday life. The study aimed to examine whether exposure to these cinematic VR scenarios could lead to improvements in psychosocial functioning in individuals with schizophrenia, compared to standard follow-up.

The objective of this study is to measure the effectiveness of cinematic basd VR for improving psychosocial functioning in schizophrenia by focusing on real-life-based immersive experiences. The other objective of this study is to measure the sense of presence of the partcipants in the cinematic virtual environment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

The rater of Personal and Social Performance Scale was blinded to the group assignment.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical stability over the past 12 weeks
  • No changes in antipsychotic medication during last 6 monhts
  • Having a score ≤70 on the PSP and and ≤61 on the Social and Occupational Functioning Assessment Scale (SOFAS)

排除标准

  • Experienced a psychotic episode or suicide attempt in the past 12 weeks
  • Received electroconvulsive therapy in the past 6 months
  • Having a diagnosis of a serious physical or neurological disorder that could impact clinical functioning or sensory systems (visual or auditory), alcohol or substance use disorder, intellectual disability, or a history of epilepsy
  • Participants with an identified suicide risk, self-harm tendencies, or violent behavior

研究组 & 干预措施

Cinematic Virtual Reality Psychososcial Treatment Program Group

Experimental

Participants received cinematic VR sessions in this group on a weekly basis during 12 weeks

干预措施: Cinematic Virtual Reality Psychososcial Treatment Program Group (Behavioral)

Control Group - Face to Face Interviews

No Intervention

This group consists of individuals with schizophrenia. Participants in this group did not receive the virtual reality intervention. They participated in weekly face-to-face, non-interventional interviews as part of treatment as usual for 12 weeks on a weekly basis.

结局指标

主要结局

Psychososcial Functioning

时间窗: 3 months

Psychosocial functioning refers to an individual's ability to interact with their environment and to perform effectively in various social roles, such as being an employee, student, spouse, family member, or friend. This definition also encompasses individuals' capacity to fulfill these roles, engage in self-care, and derive satisfaction from leisure and recreational activities. In order to measure psychososcial functioning in detail, Social Functioning Scale (SFS) was used. SFS is a self-report scale that aims to measure social functioning in schizophrenia considering the period of last three months. The scale has seven specific areas of social functioning including social engagement/withdrawal, interpersonal behavior, recreation, pro-social activities, independence-performance, independence-competence and employment.

Psychosocial Functioning

时间窗: 4 weeks

In order to measure psychosocil functioning, Personal and Social Performance Scale (PSP) was used. PSP is an interview-based evaluation scale. It provides an assessment in functioning across four dimensions including socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors. Each dimension is rated at six levels (absent, mild, manifest but not marked, marked, severe, very severe). Although each dimension is rated individually, a single score of social functioning is obtained ranging from 0 to 100. Higher score indicates better functioning.

次要结局

  • Sense of Presence(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emine Ilgın Hoşgelen

Dr

Dokuz Eylul University

研究点 (2)

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