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临床试验/NCT06692530
NCT06692530招募中不适用

Paranoid Behaviour & Threat Evaluation in Asylumseekers Diagnosed With a Psychotic Disorder and Experiencing Paranoid Delusions: A Phenomenological Qualitative Virtual Reality Study

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年11月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
Phenomenological qualitative interview Data

研究概览

简要总结

Rationale: Ethnic minorities and asylumseekers have a two- to three-times increased risk of psychosis compared to people from their host country. Among patients experiencing psychosis, paranoid delusions are a common symptom. Diagnostic assessments are challenging in this group because of language differences and sociocultural differences in interpersonal social behavior and communication. To fill this gap this research will make use of Virtual Reality (VR) to assess thoughts, behaviours and emotions in real-time. VR has a high ecological validity and its partial non-verbal nature has a clear potential in terms of a transcultural application among asylumseekers.

Objective: The main objective of this study is to discover how asylumseekers with a psychotic disorder who are experiencing paranoid delusions behave and evaluate threat in a virtual environment.

Secondary objectives: To assess the suitability and applicability of using VR within the specific population of asylumseekers with a psychotic disorder and paranoid delusions.

Study design: The study uses a mixed-methods design, combining qualitative phenomenological data and descriptive quantitative data.

Study population: Adult psychiatric patients that are seeking asylum in the Netherlands with a DSM-5 classification of a psychotic disorder and paranoid delusion (as measured by the PANSS) will be included. Furthermore, patients must receive mental health care from CTP Veldzicht, either in one of the wards (closed or open) or through ambulatory care.

Intervention: The patients will be immersed in a VR-environment using a head mounted display. Four different VR-scenarios are used, each taking up three to four minutes. Using simple movement instructions, patients are asked to walk around and observe their environment.

Main study parameters/endpoints: Phenomenological semi-structured interview. The interview measures the experience of participants in a qualitative matter. Audio recordings of the semi-structured interviews will be transcribed. These transcriptions containing rich qualitative data are the main study parameter. Additional descriptive qualitative data (demographic & symptom specific) will be gathered through questionnaires to provide quantitative insight in the sample-population (questionnaires used: PANSS, SSPS, SBQ, and VAS). Subsequently, psychiatrists working in the field of transcultural psychiatry will be interviewed about the paranoid behaviour of participants based on video and audio recordings of the VR-session.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Some participants might experience simulator sickness symptoms. No major adverse events are expected or have been documented in previous VR studies of our research group using the same VR hardware and software. The assessment will take approximately 90 minutes in total. No benefits are expected. An empathic and transparent approach, a clear consent procedure, close monitoring of participants' moods and consistently adverting an opt-out will be used.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • Aged 18 or over
  • Receiving treatment from CTP Veldzicht
  • Seeking asylum in the Netherlands, registered with Centraal Opvang Asielzoekers (COA)
  • Classification (primary or subsidiary classification) of a disorder categorized within the 'schizophreniaspectrum- and other psychotic disorders' (DSM-V)
  • Diagnosed with the symptom of paranoid delusion, defined as a PANSS score on the delusion item (P6) >2

排除标准

  • Unable to provide informed consent
  • Acutely psychotic, which means overwhelmed by psychotic symptoms, agitated, not able to participate in an interview, as judged by a therapist or socio-therapist.

结局指标

主要结局

Phenomenological qualitative interview Data

时间窗: One data collection moment per participant which takes 2.5 hours.

The interview measures the experience of participants in a qualitative matter. Audio recordings of the semi-structured interviews will be transcribed. These transcriptions containing rich qualitative data are the main study parameter.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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