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Schizophrenia DisordersCOA-VRNCT06692530

Asylumseekers Experiencing Paranoid Delusions: A Virtual Reality Study

An observational study of Schizophrenia Disorders and Paranoid Delusions, run by University Medical Center Groningen at 1 site in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia Disorders, Paranoid Delusions
How many people
15 participants
Where
1 siteNetherlands
Study dates
22 Nov 2024to 1 Jul 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The patients will be recruited from departments within the Centre for Transcultural Psychiatry Veldzicht. These departments consist of three closed-wards, one open ward, and a department that provides ambulatory-care in asylumseeker centres in the northeast of the Netherlands.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ron Haarms, MSc contact

650070910 ext. +31

r.haarms@umcg.nl

Netherlands1 site, 1 recruiting
  • CTP Veldzicht

    Balkbrug, Overijssel, 7707 AT

    Recruiting

Other trials in Netherlands

About this study

Official title: Paranoid Behaviour & Threat Evaluation in Asylumseekers Diagnosed With a Psychotic Disorder and Experiencing Paranoid Delusions: A Phenomenological Qualitative 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.

Read more

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.

Medical subject headings
Schizophrenia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phenomenological qualitative interview Data

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2024
  2. Study start22 Nov 2024
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06692530
Sponsor's protocol ID
NL84630.042.23
Acronym
COA-VR
Status last verified
Nov 2024
First submitted
14 Nov 2024
Last updated
2 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia Disorders and Paranoid Delusions, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ron Haarms, MSc (650070910 ext. +31, r.haarms@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phenomenological qualitative interview Data (time frame: One data collection moment per participant which takes 2.5 hours.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.

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