Asylumseekers Experiencing Paranoid Delusions: A Virtual Reality Study

NCT ID: NCT06692530

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-22
• Study Completion Date: 2025-07-01

Brief Summary

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.

Conditions

Schizophrenia Disorders; Paranoid Delusions

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CTP Veldzicht

Balkbrug, Overijssel, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Ron Haarms, MSc

Role: CONTACT

r.haarms@umcg.nl

650070910 ext. +31

Other Identifiers

NL84630.042.23

Identifier Type: -

Identifier Source: org_study_id