Schizophrenia DisordersNCT07027085
Investigation of the Effects of Virtual Reality Applications on Individuals Diagnosed With Schizophrenia
A study testing virtual reality in people with Schizophrenia Disorders, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
Despite all the positive facts about the use of virtual reality technology in the assessment and treatment of schizophrenia, there are few publications per year. There are few controlled studies covering the effectiveness of virtual reality programs in the training of cognitive and social skills. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Disorders
- What is being tested?
- virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2025to Dec 2025
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with schizophrenia
- Volunteering to participate in the study
- Being an adult between the ages of 18-65
- Not in an acute or exacerbated phase
- Scoring 19 or more on the Mini Mental State Examination
Who cannot join
- Patients who have another psychological or neurological disease other than schizophrenia
- Who are unable to give their own consent will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effects of Virtual Reality Applications on Sensory Processing, Cognitive Skills, Social Functioning and Disease Symptoms in Individuals Diagnosed With Schizophrenia
Despite all the positive facts about the use of virtual reality technology in the assessment and treatment of schizophrenia, there are few publications per year. There are few controlled studies covering the effectiveness of virtual reality programs in the training of cognitive and social skills. In future research, more randomized studies with more robust samples are expected, because the results of experimental studies so far encourage this new treatment approach. Therefore, the aim of this study is to examine the effects of virtual reality application on sensory, social and cognitive areas in individuals with schizophrenia.
Read the detailed description
Schizophrenia is a chronic disease that can cause serious disability and negatively affect quality of life and functionality. According to the results of studies conducted to date, it is assumed that schizophrenia is a syndrome rather than a single disease due to its different clinical types, clinical appearance, course and treatment responses that vary from patient to patient. Schizophrenia is one of the diseases that cause the most disability worldwide. According to World Health Organization data, schizophrenia is in the top ten list of diseases that cause disability for individuals aged 15-44. Individuals diagnosed with schizophrenia usually experience difficulties in the areas of Sensory Processing, Cognitive Functions and Social Skills. Sensory processing disorders in individuals with schizophrenia affect the processes of perceiving and interpreting environmental stimuli: Sounds, lights or tactile stimuli that are considered ordinary in daily life may become disturbing or there may be difficulty in combining visual and auditory information in a harmonious way. This situation also negatively affects social interactions. For example, Javitt and Freedman stated that sensory processing disorders in schizophrenia are related to both cognitive and social functioning dimensions of the disease.
Social skills are one of the most frequently affected areas in schizophrenia and various impairments can be observed. Difficulty in social interactions, introversion and communication problems are frequently observed. Difficulty in understanding facial expressions, body language or tone of voice, decreased ability to understand the emotional states of others or avoidance of social interactions and isolation can be observed. Pinkham et al. stated that social cognition is a significant problem in schizophrenia and that this situation has a direct effect on social functioning. Individuals with schizophrenia also experience impairments in their ability to recognize and express emotions. Kohler et al. emphasized that emotional processing disorders in schizophrenia make social relationships even more difficult.
Schizophrenia can lead to significant impairments especially in cognitive areas and this can significantly affect the individual's daily life. For example; difficulty in focusing on a sustained task, deficiencies in the ability to retain and use instant information, or impairments in higher-level cognitive functions such as problem solving, planning, and decision making. A meta-analysis found that individuals with schizophrenia had significant disadvantages compared to healthy individuals in all cognitive areas. One study showed that parietal lobe functions (related to motor planning) may be impaired in individuals with schizophrenia and that this situation has effects on motor control. These problems reduce the quality of life of individuals with schizophrenia and make it difficult for them to reintegrate into society. Innovative approaches such as virtual reality offer promising solutions for rehabilitation in these areas.
Virtual reality (VR) is a technology in which users experience the feeling of being in three-dimensional environments created by computers. This technology abstracts the user from the physical world and includes them in a virtual world through special headsets and sensors.
Virtual reality technology is used in various fields today. In recent years, it has been increasingly used in medicine and psychology. It is especially effective as a rehabilitation and treatment tool in various disease groups. Virtual reality applications have various advantages and limitations. Advantages: Individuals receive therapy in a controlled environment, away from the risks they may encounter in the real world. Virtual reality environments offer more realistic and impressive experiences than traditional therapies. Applications can be customized according to the needs of individuals. Virtual reality devices objectively measure and record the individual's behaviors and reactions. Limitations: The cost of virtual reality equipment and access to technology may be limited. Some individuals may experience side effects such as dizziness or nausea in virtual environments. More research is needed on the long-term effectiveness of some applications. Virtual reality applications in schizophrenia are drawing attention as an innovative approach to improving individuals' cognitive, social and sensory functions. Such applications provide an effective alternative to traditional methods by allowing therapeutic interventions in a safe environment. Virtual reality targets several areas where individuals with schizophrenia have difficulties. These include; Social Skills: Provides safe practice of social interactions by simulating real-life social situations.
Sensory Processing and Sensitivity: Sensory tolerance is developed by exposure to environmental stimuli.
Cognitive Rehabilitation: Provides tasks that improve attention, memory, and executive functions.
Delusion and Hallucination Management: Therapies that strengthen the perception of reality are applied.
The available data on virtual reality applications are currently limited due to the small number of studies conducted on the subject, and more research is needed to better evaluate its effectiveness as a treatment. However, current evidence reveals its effectiveness and versatility in successfully treating a variety of psychotic symptoms, including delusions, hallucinations, or cognitive and social skills, and suggests virtual reality as a promising new branch of research and therapy. The existing literature agrees on the safety, tolerability, and long-term durability of the therapeutic effects achieved with virtual reality. Studies have reported a decrease in social anxiety and an increase in self-confidence.
For example, in a randomized controlled trial by Park et al. on the use of virtual reality in the treatment of social skills, it was reported that it showed significant improvements in speaking skills and also provided greater motivation for treatment. Freeman et al. developed a virtual reality application that allowed the individual to reframe these thoughts by interacting with an avatar associated with the content of the delusion. In another study, virtual reality application was found to be effective in reducing the intensity and distress of delusions. Effective results were obtained in virtual reality applications used to improve cognitive functions. La Paglia et al. conducted virtual reality training for cognitive rehabilitation targeting attention and executive functions in patients with schizophrenia. Rus-Calafell et al. suggested that virtual reality intervention could be applied to cognitive rehabilitation, social skills training interventions and virtual reality-assisted therapies for psychosis, could provide a valuable method for assessing the presence of symptoms and has the potential to facilitate learning new emotional and behavioral responses.
- Conditions
- Schizophrenia Disorders
- Being tested
- virtual reality
- Keywords
- virtual reality, social skill training, cognition, sensory processing
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
The intervention group will be applied 14 sessions of virtual reality application, each session lasting 30 minutes and 2 sessions per week. The sessions will be held in a room allocated for this study in the community mental health center. The device on which the application will be made was determined as Meta Quest 3. The contents to be used in the device were determined to be in line with the areas to be examined.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Device: virtual reality |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini Mental State Examination
The Mini Mental State Examination was first published by Folstein et al. (1975). It consists of eleven items grouped under five main headings: orientation, recording memory, attention and calculation, recall, and language, and is evaluated out of a total of 30 points.
Measured: at the beginning (baseline) and end of the intervention (7 weeks)
Social Functioning Assessment Scale
The Social Functioning Assessment Scale (SAF) will be used for social functioning. This scale, developed in Turkey, assesses social functioning in schizophrenia patients with 19 items and four sub-dimensions. The factors include interpersonal relationships and entertainment with seven items, self-care with seven items, independent living skills with four items, and work life with one item. The score that can be obtained from the scale is between 19 and 57, with a high score indicating a high level of social functioning.
Measured: at the beginning (baseline) and end of the intervention (7 weeks)
Adolescent/Adult Sensory Profile
The Adolescent/Adult Sensory Profile will be used to examine sensory areas. Adolescent/Adult. Sensory Profile is a scale consisting of 60 items. It evaluates the response of 6 sensory patterns to different sensory stimuli. It is used in adolescents and adults aged 11 and above. The 60 items in the Sensory Profile are divided into four categories, each with 15 items equally divided into four categories, each belonging to a different sensory processing pattern. These are: low registration, sensory seeking, sensory sensitivity, sensory avoidance. Using a five-point Likert scale, participants are asked to rate how often they respond to the sensory event/experience described in each item. Each category results in a score range of 5 to 75. Each age group (11-18, 18-65, and 65 and above) has different norm values. The higher the score, the more characteristics the individual exhibits for sensory processing patterns. For example, the higher the score an individual obtains in the "low-recordin
Measured: at the beginning (baseline) and end of the intervention (7 weeks)
Schizophrenia Cognitive Assessment Scale
The Schizophrenia Cognitive Assessment Scale (SCAS) will be used for cognitive assessment. The Schizophrenia Cognitive Assessment Scale was developed by Keefe and colleagues in 2005 and consists of 20 items to determine the degree of cognitive impairment and its effects on daily functioning in schizophrenia patients. The items included in the scale were developed to evaluate attention, memory, reasoning and problem solving, working memory, language production and motor skills, which are frequently affected by neurocognitive impairment in schizophrenia patients and closely related to psychosocial functioning. The average application time of the scale is 12 minutes. Each of the 20 items is evaluated on a severity level ranging from 1 to 4, with higher scores indicating a greater degree of impairment. Information is obtained from three separate sources: the patient himself/herself, the patient's relative who provides information, and the interviewer, who is the physician who follows the
Measured: at the beginning (baseline) and end of the intervention (7 weeks)
Secondary outcomes (2)
Scale for the Assessment of Positive Symptoms
Scale for the Assessment of Positive Symptoms (SAPS) evaluates the level, distribution and severity of positive symptoms in patients with schizophrenia. It was developed by Andreasen. The reliability of the Turkish form was established by Erkoç et al. It is a six-point Likert-type scale with 4 subscales and 34 items, evaluated by the interviewer. The subscales are hallucinations, delusions, strange behavior and formal thought disorder. The scoring of each item ranges from 0 to 5. The total subscale scores are obtained by adding the subscale items and the total scale score is obtained by adding the subscale total scores. The total score ranges from 0 to 170.
Measured: at the beginning (baseline) and end of the intervention (7 weeks)
Scale for the Assessment of Negative Symptoms
Scale for the Assessment of Negative Symptoms (SANS) evaluates the level, distribution and severity of negative symptoms in patients with schizophrenia. It was developed by Andreasan. The reliability of the Turkish form was established by Erkoç et al. It is a six-point Likert-type measurement scale with 5 subscales and 25 items that is evaluated by the interviewer. The subscales are affective blunting, alogia, apathy, anhedonia and attention deficit. The scoring of each item varies between 0-5 and 25. The total subscale scores are obtained by adding the subscale items. The total scale score is obtained by adding the total subscale scores. The total score varies between 0-125.
Measured: at the beginning (baseline) and end of the intervention (7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start2 Jun 2025
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia DisordersStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatıma Zehra Turan, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027085
- Sponsor's protocol ID
- NiğdeOHU.OT.
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erkoç Ş, Arkonaç O, Ataklı C, Özmen E. Negatif semptomları değerlendirme ölçeğinin güvenilirliği ve geçerliliği. Düşünen Adam. 1991;4(2):14-5.
Erkoç Ş, Arkonaç O, Ataklı C, Özmen E. Pozitif semptomları değerlendirme ölçeğinin güvenilirliği ve geçerliliği. Düşünen Adam. 1991;4(2):20-4.
KİRAS F, İNCEDERE A, ESEN D, GÜRCAN MB, ABUT B, İPÇİ K, et al. Şizofreni Hastaları için Toplumsal İşlevselliği Değerlendirme Ölçeğinin geliştirilmesi: Geçerlilik ve güvenirlik çalışması. Anatolian Journal of Psychiatry/Anadolu Psikiyatri Dergisi. 2018;19.
Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
PubMed 12794644Özak N. Şizofreni Hastalarinda Bilişsel Bozukluk Düzeyini Değerlendiren Şizofreni Bilişsel Değerlendirme Ölçeğinin Türkçe Geçerlilik ve Güvenilirlik Çalişmasi: Dokuz Eylul Universitesi (Turkey); 2019.
Aydın MŞ. Adolesan/Yetişkin Duyu Profili anketi türkçe uyarlamasının geçerlilik güvenilirlik çalışması. 2015.
Rus-Calafell M, Garety P, Sason E, Craig TJK, Valmaggia LR. Virtual reality in the assessment and treatment of psychosis: a systematic review of its utility, acceptability and effectiveness. Psychol Med. 2018 Feb;48(3):362-391. doi: 10.1017/S0033291717001945. Epub 2017 Jul 24.
PubMed 28735593La Paglia F, La Cascia C, Rizzo R, Sanna M, Cangialosi F, Sideli L, et al. Virtual Reality environments to rehabilitation attention deficits in schizophrenic patients. Annual Review of CyberTherapy and Telemedicine. 2016.
Craig TK, Rus-Calafell M, Ward T, Leff JP, Huckvale M, Howarth E, Emsley R, Garety PA. AVATAR therapy for auditory verbal hallucinations in people with psychosis: a single-blind, randomised controlled trial. Lancet Psychiatry. 2018 Jan;5(1):31-40. doi: 10.1016/S2215-0366(17)30427-3. Epub 2017 Nov 23.
PubMed 29175276Freeman D, Bradley J, Antley A, Bourke E, DeWeever N, Evans N, Cernis E, Sheaves B, Waite F, Dunn G, Slater M, Clark DM. Virtual reality in the treatment of persecutory delusions: randomised controlled experimental study testing how to reduce delusional conviction. Br J Psychiatry. 2016 Jul;209(1):62-7. doi: 10.1192/bjp.bp.115.176438. Epub 2016 May 5.
PubMed 27151071Park MJ, Kim DJ, Lee U, Na EJ, Jeon HJ. A Literature Overview of Virtual Reality (VR) in Treatment of Psychiatric Disorders: Recent Advances and Limitations. Front Psychiatry. 2019 Jul 19;10:505. doi: 10.3389/fpsyt.2019.00505. eCollection 2019.
PubMed 31379623Macedo M, Marques A, Queirós C. Virtual reality in assessment and treatment of schizophrenia: a systematic review. Jornal brasileiro de psiquiatria. 2015;64(1):70-81.
Bisso E, Signorelli MS, Milazzo M, Maglia M, Polosa R, Aguglia E, Caponnetto P. Immersive Virtual Reality Applications in Schizophrenia Spectrum Therapy: A Systematic Review. Int J Environ Res Public Health. 2020 Aug 22;17(17):6111. doi: 10.3390/ijerph17176111.
PubMed 32842579Freeman D. Studying and treating schizophrenia using virtual reality: a new paradigm. Schizophr Bull. 2008 Jul;34(4):605-10. doi: 10.1093/schbul/sbn020. Epub 2008 Mar 28.
PubMed 18375568Ertürk NB, Değirmenci FN. SANAL GERÇEKLİK (VR) TEKNOLOJİLERİNİN MİMARLIK SEKTÖRÜNDEKİ YERİ. Karesi Journal of Architecture.2(2):24-36.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Virtual Reality Applications on Sensory Processing, Cognitive Skills, Social Functioning and Disease Symptoms in Individuals Diagnosed With Schizophrenia
- ClinicalTrials.gov ID
- NCT07027085
- Acronym / sponsor ID
- NiğdeOHU.OT.
- Conditions
- Schizophrenia Disorders
- Keywords
- virtual reality, social skill training, cognition, sensory processing
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Jun 2025 (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.
Despite all the positive facts about the use of virtual reality technology in the assessment and treatment of schizophrenia, there are few publications per year. There are few controlled studies covering the effectiveness of virtual reality programs in the training of cognitive and social skills. In future research, more randomized studies with more robust samples are expected, because the results of experimental studies so far encourage this new treatment approach. Therefore, the aim of this study is to examine the effects of virtual reality application on sensory, social and cognitive areas in individuals with schizophrenia.
Detailed description
Schizophrenia is a chronic disease that can cause serious disability and negatively affect quality of life and functionality. According to the results of studies conducted to date, it is assumed that schizophrenia is a syndrome rather than a single disease due to its different clinical types, clinical appearance, course and treatment responses that vary from patient to patient. Schizophrenia is one of the diseases that cause the most disability worldwide. According to World Health Organization data, schizophrenia is in the top ten list of diseases that cause disability for individuals aged 15-44. Individuals diagnosed with schizophrenia usually experience difficulties in the areas of Sensory Processing, Cognitive Functions and Social Skills. Sensory processing disorders in individuals with schizophrenia affect the processes of perceiving and interpreting environmental stimuli: Sounds, lights or tactile stimuli that are considered ordinary in daily life may become disturbing or there may be difficulty in combining visual and auditory information in a harmonious way. This situation also negatively affects social interactions. For example, Javitt and Freedman stated that sensory processing disorders in schizophrenia are related to both cognitive and social functioning dimensions of the disease.
Social skills are one of the most frequently affected areas in schizophrenia and various impairments can be observed. Difficulty in social interactions, introversion and communication problems are frequently observed. Difficulty in understanding facial expressions, body language or tone of voice, decreased ability to understand the emotional states of others or avoidance of social interactions and isolation can be observed. Pinkham et al. stated that social cognition is a significant problem in schizophrenia and that this situation has a direct effect on social functioning. Individuals with schizophrenia also experience impairments in their ability to recognize and express emotions. Kohler et al. emphasized that emotional processing disorders in schizophrenia make social relationships even more difficult.
Schizophrenia can lead to significant impairments especially in cognitive areas and this can significantly affect the individual's daily life. For example; difficulty in focusing on a sustained task, deficiencies in the ability to retain and use instant information, or impairments in higher-level cognitive functions such as problem solving, planning, and decision making. A meta-analysis found that individuals with schizophrenia had significant disadvantages compared to healthy individuals in all cognitive areas. One study showed that parietal lobe functions (related to motor planning) may be impaired in individuals with schizophrenia and that this situation has effects on motor control. These problems reduce the quality of life of individuals with schizophrenia and make it difficult for them to reintegrate into society. Innovative approaches such as virtual reality offer promising solutions for rehabilitation in these areas.
Virtual reality (VR) is a technology in which users experience the feeling of being in three-dimensional environments created by computers. This technology abstracts the user from the physical world and includes them in a virtual world through special headsets and sensors.
Virtual reality technology is used in various fields today. In recent years, it has been increasingly used in medicine and psychology. It is especially effective as a rehabilitation and treatment tool in various disease groups. Virtual reality applications have various advantages and limitations. Advantages: Individuals receive therapy in a controlled environment, away from the risks they may encounter in the real world. Virtual reality environments offer more realistic and impressive experiences than traditional therapies. Applications can be customized according to the needs of individuals. Virtual reality devices objectively measure and record the individual's behaviors and reactions. Limitations: The cost of virtual reality equipment and access to technology may be limited. Some individuals may experience side effects such as dizziness or nausea in virtual environments. More research is needed on the long-term effectiveness of some applications. Virtual reality applications in schizophrenia are drawing attention as an innovative approach to improving individuals' cognitive, social and sensory functions. Such applications provide an effective alternative to traditional methods by allowing therapeutic interventions in a safe environment. Virtual reality targets several areas where individuals with schizophrenia have difficulties. These include; Social Skills: Provides safe practice of social interactions by simulating real-life social situations.
Sensory Processing and Sensitivity: Sensory tolerance is developed by exposure to environmental stimuli.
Cognitive Rehabilitation: Provides tasks that improve attention, memory, and executive functions.
Delusion and Hallucination Management: Therapies that strengthen the perception of reality are applied.
The available data on virtual reality applications are currently limited due to the small number of studies conducted on the subject, and more research is needed to better evaluate its effectiveness as a treatment. However, current evidence reveals its effectiveness and versatility in successfully treating a variety of psychotic symptoms, including delusions, hallucinations, or cognitive and social skills, and suggests virtual reality as a promising new branch of research and therapy. The existing literature agrees on the safety, tolerability, and long-term durability of the therapeutic effects achieved with virtual reality. Studies have reported a decrease in social anxiety and an increase in self-confidence.
For example, in a randomized controlled trial by Park et al. on the use of virtual reality in the treatment of social skills, it was reported that it showed significant improvements in speaking skills and also provided greater motivation for treatment. Freeman et al. developed a virtual reality application that allowed the individual to reframe these thoughts by interacting with an avatar associated with the content of the delusion. In another study, virtual reality application was found to be effective in reducing the intensity and distress of delusions. Effective results were obtained in virtual reality applications used to improve cognitive functions. La Paglia et al. conducted virtual reality training for cognitive rehabilitation targeting attention and executive functions in patients with schizophrenia. Rus-Calafell et al. suggested that virtual reality intervention could be applied to cognitive rehabilitation, social skills training interventions and virtual reality-assisted therapies for psychosis, could provide a valuable method for assessing the presence of symptoms and has the potential to facilitate learning new emotional and behavioral responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Device: virtual reality |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being diagnosed with schizophrenia
- Volunteering to participate in the study
- Being an adult between the ages of 18-65
- Not in an acute or exacerbated phase
- Scoring 19 or more on the Mini Mental State Examination
Key exclusion criteria (2 listed)
- Patients who have another psychological or neurological disease other than schizophrenia
- Who are unable to give their own consent will not be included in the study.
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 |
|---|---|---|
| virtual realityThe intervention group will be applied 14 sessions of virtual reality application, each session lasting 30 minutes and 2 sessions per week. The sessions will be held in a room allocated for this study in the community mental health center. The device on which the application will be made was determined as Meta Quest 3. The contents to be used in the device were determined to be in line with the areas to be examined. | Device | intervention group |
Primary outcome
Mini Mental State Examination
Time frame: at the beginning (baseline) and end of the intervention (7 weeks)
The Mini Mental State Examination was first published by Folstein et al. (1975). It consists of eleven items grouped under five main headings: orientation, recording memory, attention and calculation, recall, and language, and is evaluated out of a total of 30 points.
Social Functioning Assessment Scale
Time frame: at the beginning (baseline) and end of the intervention (7 weeks)
The Social Functioning Assessment Scale (SAF) will be used for social functioning. This scale, developed in Turkey, assesses social functioning in schizophrenia patients with 19 items and four sub-dimensions. The factors include interpersonal relationships and entertainment with seven items, self-care with seven items, independent living skills with four items, and work life with one item. The score that can be obtained from the scale is between 19 and 57, with a high score indicating a high level of social functioning.
Adolescent/Adult Sensory Profile
Time frame: at the beginning (baseline) and end of the intervention (7 weeks)
The Adolescent/Adult Sensory Profile will be used to examine sensory areas. Adolescent/Adult. Sensory Profile is a scale consisting of 60 items. It evaluates the response of 6 sensory patterns to different sensory stimuli. It is used in adolescents and adults aged 11 and above. The 60 items in the Sensory Profile are divided into four categories, each with 15 items equally divided into four categories, each belonging to a different sensory processing pattern. These are: low registration, sensory seeking, sensory sensitivity, sensory avoidance. Using a five-point Likert scale, participants are asked to rate how often they respond to the sensory event/experience described in each item. Each category results in a score range of 5 to 75. Each age group (11-18, 18-65, and 65 and above) has different norm values. The higher the score, the more characteristics the individual exhibits for sensory processing patterns. For example, the higher the score an individual obtains in the "low-recordin
Schizophrenia Cognitive Assessment Scale
Time frame: at the beginning (baseline) and end of the intervention (7 weeks)
The Schizophrenia Cognitive Assessment Scale (SCAS) will be used for cognitive assessment. The Schizophrenia Cognitive Assessment Scale was developed by Keefe and colleagues in 2005 and consists of 20 items to determine the degree of cognitive impairment and its effects on daily functioning in schizophrenia patients. The items included in the scale were developed to evaluate attention, memory, reasoning and problem solving, working memory, language production and motor skills, which are frequently affected by neurocognitive impairment in schizophrenia patients and closely related to psychosocial functioning. The average application time of the scale is 12 minutes. Each of the 20 items is evaluated on a severity level ranging from 1 to 4, with higher scores indicating a greater degree of impairment. Information is obtained from three separate sources: the patient himself/herself, the patient's relative who provides information, and the interviewer, who is the physician who follows the
2 secondary outcomes
Scale for the Assessment of Positive Symptoms
Time frame: at the beginning (baseline) and end of the intervention (7 weeks)
Scale for the Assessment of Negative Symptoms
Time frame: at the beginning (baseline) and end of the intervention (7 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- BackgroundErkoç Ş, Arkonaç O, Ataklı C, Özmen E. Negatif semptomları değerlendirme ölçeğinin güvenilirliği ve geçerliliği. Düşünen Adam. 1991;4(2):14-5.
- BackgroundErkoç Ş, Arkonaç O, Ataklı C, Özmen E. Pozitif semptomları değerlendirme ölçeğinin güvenilirliği ve geçerliliği. Düşünen Adam. 1991;4(2):20-4.
- BackgroundKİRAS F, İNCEDERE A, ESEN D, GÜRCAN MB, ABUT B, İPÇİ K, et al. Şizofreni Hastaları için Toplumsal İşlevselliği Değerlendirme Ölçeğinin geliştirilmesi: Geçerlilik ve güvenirlik çalışması. Anatolian Journal of Psychiatry/Anadolu Psikiyatri Dergisi. 2018;19.
- Background: PubMed 12794644Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.
- BackgroundÖzak N. Şizofreni Hastalarinda Bilişsel Bozukluk Düzeyini Değerlendiren Şizofreni Bilişsel Değerlendirme Ölçeğinin Türkçe Geçerlilik ve Güvenilirlik Çalişmasi: Dokuz Eylul Universitesi (Turkey); 2019.
- BackgroundAydın MŞ. Adolesan/Yetişkin Duyu Profili anketi türkçe uyarlamasının geçerlilik güvenilirlik çalışması. 2015.
- Background: PubMed 28735593Rus-Calafell M, Garety P, Sason E, Craig TJK, Valmaggia LR. Virtual reality in the assessment and treatment of psychosis: a systematic review of its utility, acceptability and effectiveness. Psychol Med. 2018 Feb;48(3):362-391. doi: 10.1017/S0033291717001945. Epub 2017 Jul 24.
- BackgroundLa Paglia F, La Cascia C, Rizzo R, Sanna M, Cangialosi F, Sideli L, et al. Virtual Reality environments to rehabilitation attention deficits in schizophrenic patients. Annual Review of CyberTherapy and Telemedicine. 2016.
- Background: PubMed 29175276Craig TK, Rus-Calafell M, Ward T, Leff JP, Huckvale M, Howarth E, Emsley R, Garety PA. AVATAR therapy for auditory verbal hallucinations in people with psychosis: a single-blind, randomised controlled trial. Lancet Psychiatry. 2018 Jan;5(1):31-40. doi: 10.1016/S2215-0366(17)30427-3. Epub 2017 Nov 23.
- Background: PubMed 27151071Freeman D, Bradley J, Antley A, Bourke E, DeWeever N, Evans N, Cernis E, Sheaves B, Waite F, Dunn G, Slater M, Clark DM. Virtual reality in the treatment of persecutory delusions: randomised controlled experimental study testing how to reduce delusional conviction. Br J Psychiatry. 2016 Jul;209(1):62-7. doi: 10.1192/bjp.bp.115.176438. Epub 2016 May 5.
- Background: PubMed 31379623Park MJ, Kim DJ, Lee U, Na EJ, Jeon HJ. A Literature Overview of Virtual Reality (VR) in Treatment of Psychiatric Disorders: Recent Advances and Limitations. Front Psychiatry. 2019 Jul 19;10:505. doi: 10.3389/fpsyt.2019.00505. eCollection 2019.
- BackgroundMacedo M, Marques A, Queirós C. Virtual reality in assessment and treatment of schizophrenia: a systematic review. Jornal brasileiro de psiquiatria. 2015;64(1):70-81.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality in people with Schizophrenia Disorders, run by Nigde Omer Halisdemir 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 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 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 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?
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?
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?
Mini Mental State Examination (time frame: at the beginning (baseline) and end of the intervention (7 weeks)). The study lists 4 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 NCT07027085, which also lists 26 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 18 Jun 2025.