SchizophreniaNCT07326618
Cinematic Virtual Reality Intervention for Improving Psychosocial Functioning in Individuals With Schizophrenia
A study testing Cinematic Virtual Reality Psychososcial Treatment Program Group in people with Schizophrenia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cinematic Virtual Reality Psychososcial Treatment Program Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2023to 17 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Virtual Reality Application in Improving Psychosocial Dysfunction in Schizophrenia
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.
Read the detailed description
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.
- Conditions
- Schizophrenia
- Being tested
- Cinematic Virtual Reality Psychososcial Treatment Program Group
- Keywords
- schizophrenia, virtual reality, psychosocial functioning, social cognition, neurocognition, sense of presence
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinematic Virtual Reality Psychososcial Treatment Program GroupBehavioural
Also called cVR-PTP
cVR-PTP
- Week - Orientation to the Virtual Environment: Ability to use the VR headset, visual-spatial awareness related to the virtual environment
- Week - Orientation to the Virtual Environment: Ability to use the VR headset, visual-spatial awareness related to the virtual environment
- Week - Self-Care: Waking up in the morning, taking a shower
- Week - Social Interaction: Waiting at a crowded public transport stop, interacting with others
- Week - Mobility: Traveling with others on a tram
- Week - Mobility: Traveling with others on a ferry
- Week - Mobility and Daily Living Activities: Shopping at a traditional bazaar
- Week - Social Interaction: Going alone to a café
- Week - Daily Living Activities: Experiencing a grocery shopping
- Week - Independent Time Activities - Social Interaction: Participating in a cooking workshop
- Week - Social Interaction: watching aTV show with others
- Week - Social Interaction: Being in a pleasant family and friends setting
| Study group | Role | What they receive |
|---|---|---|
| Cinematic Virtual Reality Psychososcial Treatment Program Group | Experimental | Participants received cinematic VR sessions in this group on a weekly basis during 12 weeks Receives: Behavioral: Cinematic Virtual Reality Psychososcial Treatment Program Group |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychososcial Functioning
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.
Measured: 3 months
Psychosocial Functioning
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.
Measured: 4 weeks
Secondary outcomes (1)
Sense of Presence
Sense of presence refers to 'being in the environment'. Virtual reality environments require a relative level of sense of presence to provide immersive effect. Sense of presence is measured in cVR-PTP group in a weekly basis after each session. Sense of presence was measured by using Presence Questionnaire (PQ). It is a Likert-type self-report scale with a five-factor structure: involvement, adaptation/immersion, sensory fidelity, interface quality and interaction. Participants who have experienced a virtual reality environment rate each item on a scale from 1 (not at all) to 5 (completely). The scale was originally developed by Witmer et al.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start12 Apr 2023
- Primary completion15 Mar 2024
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental group received received a cinematic virtual reality-based psychosocial intervention during 12 weeks on a weekly basis. The intervention consisted of different cinematic VR sessions delivered weekly. Sessions were designed to address psychosocial functioning, social interaction, and daily functioning. Participants continued to have their usual medical treatment. The control group also consisted of individuals with schizophrenia. Participants in this group did not receive the virtual reality intervention and they continued to receive treatment as usual throughout the study period. They participated in weekly face-to-face, non-interventional interviews during 12 weeks.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Ilgın Hoşgelen, Dokuz Eylul University
- Investigators
- Köksal Alptekin, MD, Professor, Principal investigator, Dokuz Eylul UniversityFaik Kartelli, PhD, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326618
- Sponsor's protocol ID
- 5297-GOA-2021/24-12
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data that underlie the results reported in this study will be shared upon reasonable request to the corresponding author, beginning after publication of the primary results.
Publications
Bell, I.H., Pot-Kolder, R., Rizzo, A. et al. Advances in the use of virtual reality to treat mental health conditions. Nat Rev Psychol 3, 552-567 (2024). https://doi.org/10.1038/s44159-024-00334-9
Witmer B. G., Jerome C. J. and Singer M. J. , "The Factor Structure of the Presence Questionnaire," in Presence, vol. 14, no. 3, pp. 298-312, June 2005, doi: 10.1162/105474605323384654.
Priebe S. Social outcomes in schizophrenia. Br J Psychiatry Suppl. 2007 Aug;50:s15-20. doi: 10.1192/bjp.191.50.s15.
PubMed 18019039Bosc M. Assessment of social functioning in depression. Compr Psychiatry. 2000 Jan-Feb;41(1):63-9. doi: 10.1016/s0010-440x(00)90133-0.
PubMed 10646621Schroeder AH, Bogie BJM, Rahman TT, Therond A, Matheson H, Guimond S. Feasibility and Efficacy of Virtual Reality Interventions to Improve Psychosocial Functioning in Psychosis: Systematic Review. JMIR Ment Health. 2022 Feb 18;9(2):e28502. doi: 10.2196/28502.
PubMed 35179501Wiebe A, Kannen K, Selaskowski B, Mehren A, Thone AK, Pramme L, Blumenthal N, Li M, Asche L, Jonas S, Bey K, Schulze M, Steffens M, Pensel MC, Guth M, Rohlfsen F, Ekhlas M, Lugering H, Fileccia H, Pakos J, Lux S, Philipsen A, Braun N. Virtual reality in the diagnostic and therapy for mental disorders: A systematic review. Clin Psychol Rev. 2022 Dec;98:102213. doi: 10.1016/j.cpr.2022.102213. Epub 2022 Oct 30.
PubMed 36356351
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Virtual Reality Application in Improving Psychosocial Dysfunction in Schizophrenia
- ClinicalTrials.gov ID
- NCT07326618
- Acronym / sponsor ID
- 5297-GOA-2021/24-12
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, virtual reality, psychosocial functioning, social cognition, neurocognition, sense of presence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The experimental group received received a cinematic virtual reality-based psychosocial intervention during 12 weeks on a weekly basis. The intervention consisted of different cinematic VR sessions delivered weekly. Sessions were designed to address psychosocial functioning, social interaction, and daily functioning. Participants continued to have their usual medical treatment. The control group also consisted of individuals with schizophrenia. Participants in this group did not receive the virtual reality intervention and they continued to receive treatment as usual throughout the study period. They participated in weekly face-to-face, non-interventional interviews during 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Cinematic Virtual Reality Psychososcial Treatment Program Group | Experimental | Behavioral: Cinematic Virtual Reality Psychososcial Treatment Program GroupParticipants received cinematic VR sessions in this group on a weekly basis during 12 weeks |
| 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cinematic Virtual Reality Psychososcial Treatment Program GroupAlso: cVR-PTPcVR-PTP 1. Week - Orientation to the Virtual Environment: Ability to use the VR headset, visual-spatial awareness related to the virtual environment 2. Week - Orientation to the Virtual Environment: Ability to use the VR headset, visual-spatial awareness related to the virtual environment 3. Week - Self-Care: Waking up in the morning, taking a shower 4. Week - Social Interaction: Waiting at a crowded public transport stop, interacting with others 5. Week - Mobility: Traveling with others on a tram 6. Week - Mobility: Traveling with others on a ferry 7. Week - Mobility and Daily Living Activities: Shopping at a traditional bazaar 8. Week - Social Interaction: Going alone to a café 9. Week - Daily Living Activities: Experiencing a grocery shopping 10. Week - Independent Time Activities - Social Interaction: Participating in a cooking workshop 11. Week - Social Interaction: watching aTV show with others 12. Week - Social Interaction: Being in a pleasant family and friends setting | Behavioural | Cinematic Virtual Reality Psychososcial Treatment Program Group |
Primary outcome
Psychososcial Functioning
Time frame: 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
Time frame: 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.
1 secondary outcome
Sense of Presence
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- BackgroundBell, I.H., Pot-Kolder, R., Rizzo, A. et al. Advances in the use of virtual reality to treat mental health conditions. Nat Rev Psychol 3, 552-567 (2024). https://doi.org/10.1038/s44159-024-00334-9
- BackgroundWitmer B. G., Jerome C. J. and Singer M. J. , "The Factor Structure of the Presence Questionnaire," in Presence, vol. 14, no. 3, pp. 298-312, June 2005, doi: 10.1162/105474605323384654.
- Background: PubMed 18019039Priebe S. Social outcomes in schizophrenia. Br J Psychiatry Suppl. 2007 Aug;50:s15-20. doi: 10.1192/bjp.191.50.s15.
- Background: PubMed 10646621Bosc M. Assessment of social functioning in depression. Compr Psychiatry. 2000 Jan-Feb;41(1):63-9. doi: 10.1016/s0010-440x(00)90133-0.
- Background: PubMed 35179501Schroeder AH, Bogie BJM, Rahman TT, Therond A, Matheson H, Guimond S. Feasibility and Efficacy of Virtual Reality Interventions to Improve Psychosocial Functioning in Psychosis: Systematic Review. JMIR Ment Health. 2022 Feb 18;9(2):e28502. doi: 10.2196/28502.
- Background: PubMed 36356351Wiebe A, Kannen K, Selaskowski B, Mehren A, Thone AK, Pramme L, Blumenthal N, Li M, Asche L, Jonas S, Bey K, Schulze M, Steffens M, Pensel MC, Guth M, Rohlfsen F, Ekhlas M, Lugering H, Fileccia H, Pakos J, Lux S, Philipsen A, Braun N. Virtual reality in the diagnostic and therapy for mental disorders: A systematic review. Clin Psychol Rev. 2022 Dec;98:102213. doi: 10.1016/j.cpr.2022.102213. Epub 2022 Oct 30.
- Individual participant dataSharing planned: Yes. De-identified individual participant data that underlie the results reported in this study will be shared upon reasonable request to the corresponding author, beginning after publication of the primary results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Köksal Alptekin, MD, Professor principal investigator
Dokuz Eylul University
Faik Kartelli, PhD principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cinematic Virtual Reality Psychososcial Treatment Program Group in people with Schizophrenia, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 Jan 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychososcial Functioning (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07326618, which also lists 6 linked publications.
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 12 Jan 2026.