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NCT Number: NCT06692530

Asylumseekers Experiencing Paranoid Delusions: A Virtual Reality Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CTP Veldzicht

Balkbrug, Overijssel, 7707 AT, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Phenomenological qualitative interview Data

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ron Haarms, MSc

CONTACT

[email protected]

650070910 ext. +31

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Acronym: COA-VR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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