Clinical trial NCT07027085: Investigation of the Effects of Virtual Reality Applications on Individuals Diagnosed With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Schizophrenia Disorders
Keywords: virtual reality
social skill training
cognition
sensory processing
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mini Mental State Examination
timeFrame: at the beginning (baseline) and end of the intervention (7 weeks)
measure: Social Functioning Assessment Scale
timeFrame: at the beginning (baseline) and end of the intervention (7 weeks)
measure: Adolescent/Adult Sensory Profile
timeFrame: at the beginning (baseline) and end of the intervention (7 weeks)
measure: Schizophrenia Cognitive Assessment Scale
timeFrame: at the beginning (baseline) and end of the intervention (7 weeks)
Secondary outcomes:
measure: Scale for the Assessment of Positive Symptoms
timeFrame: at the beginning (baseline) and end of the intervention (7 weeks)
measure: Scale for the Assessment of Negative Symptoms
timeFrame: at the beginning (baseline) and end of the intervention (7 weeks)
Other outcomes:
Locations:
city: Niğde
country: Turkey
facility: Niğde Ömer Halisdemir University
Study officials:
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