Cognitive Ability GeneralNCT07111689
The Effect of Virtual Reality on Cognitive Skills in Schizophrenia
A study testing Conventional Occupational Therapy Interventiın and Virtual Reality İntervention in people with Cognitive Ability General and Virtual Reality, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to examine the effect of virtual reality intervention, given in addition to conventional occupational therapy intervention, on general cognitive functions (attention, orientation, memory, visual skills, visual-motor skills, praxis, executive functions, etc.) in individuals with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cognitive Ability General, Virtual Reality, Virtual Reality Cognitive Training
- What is being tested?
- Conventional Occupational Therapy Interventiın and Virtual Reality İntervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2023to 13 Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) age between 18 and 65 years,
- (2) Participants must have been diagnosed with Schizophrenia according to the ICD-10 diagnostic criteria,
- (3) Participants must be able to read and write at a level that will allow them to understand the content of the study,
- (4) There must be no severe cognitive impairment diagnosed that would prevent participation in the study,
- (5) Participants' antipsychotic treatments must be stable (no medication changes in the last 3 months),
- (6) Participants must be competent to provide informed consent
Who cannot join
- (1) Existence of additional diagnoses such as schizoaffective disorder, bipolar disorder or severe depressive disorder,
- (2) Existence of active substance or alcohol addiction diagnosed in the last 6 months,
- (3) Presence of diseases that may affect cognitive functions such as epilepsy, dementia, Parkinson's disease,
- (4) Exclusion of individuals who have active psychotic episodes or severe agitation during the study period,
- (5) Exclusion of individuals who are at risk of harming themselves or others,
- (6) For female participants, there is pregnancy or breastfeeding,
- (7) There are conditions such as visual or hearing impairment that may prevent active participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality for Cognitive Enhancement in Schizophrenia: A Randomized Controlled Trial
This study was conducted to examine the effect of virtual reality intervention, given in addition to conventional occupational therapy intervention, on general cognitive functions (attention, orientation, memory, visual skills, visual-motor skills, praxis, executive functions, etc.) in individuals with schizophrenia. This study was designed in accordance with the CONSORT statement, which standardizes randomized controlled trials. Additionally, the study was approved by a university's scientific research ethics committee.
Read the detailed description
This study was designed as a randomized controlled trial and conducted using the CONSORT checklist. Individuals who met the inclusion and exclusion criteria were included in the study. Both groups received traditional occupational therapy intervention, while the intervention group also received virtual reality intervention. All intervention procedures in the study were planned to take place three days a week for eight weeks, with each session lasting 45 minutes. A total of 114 individuals were included in the study; 54 were in the control group and 60 were in the intervention group.
Interventions
Conventional occupational therapy intervention approach was applied in both groups. The intervention group additionally received VR application with Microsoft Xbox 360 and Kinect. The interventions consisted of 45-minute sessions 3 days a week for 8 weeks. The intervention procedures are described in detail below and all interventions were performed by the last author of the study :
Conventional Occupational Therapy Intervention:
1-2. Week: Occupation-based interventions for visual skills Within the framework of the occupational therapy intervention calendar, in the first two weeks, participants were given training on visual memory, figure-ground perception, visual discrimination, visual completion, spatial perception, etc., which are the sub-parameters of visual perception skills. It is aimed to increase the visual skill levels of people by making interventions to improve the parameters. Response plan; As a result of the participants' occupation preferences and evaluation results, it was created and implemented using client-centered occupations that aim to increase people's visual skill levels.
3-6. Week: Social Skills Training In these weeks, it was aimed to develop different social skill levels of the participants by using various occupations related to the problematic areas of social skills with personalized targeted occupations. Within the framework of the intervention plan, various activities were prepared to develop skills such as "listening to others, making requests, expressing positive emotions and expressing unpleasant emotions", which are among the basic social skills areas. In addition, social skills parameters such as communication skills, assertiveness skills, conflict management skills, social life skills, friendship skills, interpersonal skills, health maintenance skills, professional/work skills were also included in the intervention plan. During these weeks, social skills were practiced with different tasks and sequential operations, and the development of memory, attention, orientation, praxis and executive skills was also aimed.
7-8. Week: Interventions for participation problems in ADLs Participants' problems in ADLs were identified through client-centered interviews and assessments, and their participation problems were evaluated in terms of personal, environmental and occupation-related factors. It was aimed to solve these problems by applying a holistic client-centered intervention approach to participation problems. During these weeks, the client-centered intervention approach aimed to improve cognitive functions, especially at the level of executive skills such as problem solving, time management, task initiation and completion.
VR Intervention Procedure In this study, the Xbox 360 gaming console and Kinect sensor were utilized for the virtual reality (VR) intervention. The Xbox 360 functions as an interactive gaming platform, while the Kinect sensor is a motion-detection device that captures users' positions and movements through an integrated camera and sensors.
The selection of games for the VR intervention was conducted in collaboration with experts from various disciplines. The evaluation process considered the cognitive and functional demands required for successful gameplay, the potential skills each game could enhance, and the overall therapeutic purpose of the selected games. Following an independent assessment of each game, nine games were identified as suitable for the intervention. Given that all selected games shared similar functional requirements, participants were provided access to the full set of games to optimize engagement and motivation. The specific games and the cognitive functions they target are detailed in Appendix 1.
The intervention was conducted in a designated unit with a total area of approximately 30 m². To mitigate the risk of falls, the flooring of the intervention space was covered with a soft, impact-absorbing surface.
- Conditions
- Cognitive Ability General, Virtual Reality, Virtual Reality Cognitive Training, Schizophrenia Disorder
- Being tested
- Conventional Occupational Therapy Interventiın, Virtual Reality İntervention
- Keywords
- schizoprenia, virtual reality, cognitive
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Occupational Therapy InterventiınBehavioural
1-2. Week: Occupation-based interventions for visual skills 3-6. Week: Social Skills Training 7-8. Week: Interventions for participation problems in ADLs
Virtual Reality İnterventionBehavioural
In this study, the Xbox 360 gaming console and Kinect sensor were utilized for the virtual reality (VR) intervention. The Xbox 360 functions as an interactive gaming platform, while the Kinect sensor is a motion-detection device that captures users' positions and movements through an integrated camera and sensors. The selection of games for the VR intervention was conducted in collaboration with experts from various disciplines. The evaluation process considered the cognitive and functional demands required for successful gameplay, the potential skills each game could enhance, and the overall therapeutic purpose of the selected games. Following an independent assessment of each game, nine games were identified as suitable for the intervention. Given that all selected games shared similar functional requirements, participants were provided access to the full set of games to optimize engagement and motivation.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | cognitive rehabilitation with conventional occupational therapy intervention Receives: Behavioral: Conventional Occupational Therapy Interventiın |
| Study Group | Experimental | virtual reality intervention in addition to conventional occupational therapy intervention Receives: Behavioral: Conventional Occupational Therapy Interventiın; Behavioral: Virtual Reality İntervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
The LOTCA is a performance test that consists of 20 items. The test includes testing materials such as card decks, colored blocks, a pegboard set, and other items. Additionally, a manual is provided that defines the cognitive domains assessed and provides administration instructions, and specific scoring guidelines. The LOTCA was scored on a Likert-type scale from 1 to 4, except for items 1-5 which related to categorization, unstructured Risk Object Classification, and structured Risk Object Classification. Higher scores indicate better cognitive functions
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start1 Apr 2023
- Primary completion21 Oct 2023
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Ability GeneralStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkan Torpil, PhD, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111689
- Sponsor's protocol ID
- 2022/10
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality for Cognitive Enhancement in Schizophrenia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07111689
- Acronym / sponsor ID
- 2022/10
- Conditions
- Cognitive Ability General, Virtual Reality, Virtual Reality Cognitive Training, Schizophrenia Disorder
- Keywords
- schizoprenia, virtual reality, cognitive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 21 Oct 2023 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 8 Aug 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.
This study was conducted to examine the effect of virtual reality intervention, given in addition to conventional occupational therapy intervention, on general cognitive functions (attention, orientation, memory, visual skills, visual-motor skills, praxis, executive functions, etc.) in individuals with schizophrenia. This study was designed in accordance with the CONSORT statement, which standardizes randomized controlled trials. Additionally, the study was approved by a university's scientific research ethics committee.
Detailed description
This study was designed as a randomized controlled trial and conducted using the CONSORT checklist. Individuals who met the inclusion and exclusion criteria were included in the study. Both groups received traditional occupational therapy intervention, while the intervention group also received virtual reality intervention. All intervention procedures in the study were planned to take place three days a week for eight weeks, with each session lasting 45 minutes. A total of 114 individuals were included in the study; 54 were in the control group and 60 were in the intervention group.
Interventions
Conventional occupational therapy intervention approach was applied in both groups. The intervention group additionally received VR application with Microsoft Xbox 360 and Kinect. The interventions consisted of 45-minute sessions 3 days a week for 8 weeks. The intervention procedures are described in detail below and all interventions were performed by the last author of the study :
Conventional Occupational Therapy Intervention:
1-2. Week: Occupation-based interventions for visual skills Within the framework of the occupational therapy intervention calendar, in the first two weeks, participants were given training on visual memory, figure-ground perception, visual discrimination, visual completion, spatial perception, etc., which are the sub-parameters of visual perception skills. It is aimed to increase the visual skill levels of people by making interventions to improve the parameters. Response plan; As a result of the participants' occupation preferences and evaluation results, it was created and implemented using client-centered occupations that aim to increase people's visual skill levels.
3-6. Week: Social Skills Training In these weeks, it was aimed to develop different social skill levels of the participants by using various occupations related to the problematic areas of social skills with personalized targeted occupations. Within the framework of the intervention plan, various activities were prepared to develop skills such as "listening to others, making requests, expressing positive emotions and expressing unpleasant emotions", which are among the basic social skills areas. In addition, social skills parameters such as communication skills, assertiveness skills, conflict management skills, social life skills, friendship skills, interpersonal skills, health maintenance skills, professional/work skills were also included in the intervention plan. During these weeks, social skills were practiced with different tasks and sequential operations, and the development of memory, attention, orientation, praxis and executive skills was also aimed.
7-8. Week: Interventions for participation problems in ADLs Participants' problems in ADLs were identified through client-centered interviews and assessments, and their participation problems were evaluated in terms of personal, environmental and occupation-related factors. It was aimed to solve these problems by applying a holistic client-centered intervention approach to participation problems. During these weeks, the client-centered intervention approach aimed to improve cognitive functions, especially at the level of executive skills such as problem solving, time management, task initiation and completion.
VR Intervention Procedure In this study, the Xbox 360 gaming console and Kinect sensor were utilized for the virtual reality (VR) intervention. The Xbox 360 functions as an interactive gaming platform, while the Kinect sensor is a motion-detection device that captures users' positions and movements through an integrated camera and sensors.
The selection of games for the VR intervention was conducted in collaboration with experts from various disciplines. The evaluation process considered the cognitive and functional demands required for successful gameplay, the potential skills each game could enhance, and the overall therapeutic purpose of the selected games. Following an independent assessment of each game, nine games were identified as suitable for the intervention. Given that all selected games shared similar functional requirements, participants were provided access to the full set of games to optimize engagement and motivation. The specific games and the cognitive functions they target are detailed in Appendix 1.
The intervention was conducted in a designated unit with a total area of approximately 30 m². To mitigate the risk of falls, the flooring of the intervention space was covered with a soft, impact-absorbing surface.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Behavioral: Conventional Occupational Therapy Interventiıncognitive rehabilitation with conventional occupational therapy intervention |
| Study Group | Experimental | Behavioral: Conventional Occupational Therapy Interventiın, Behavioral: Virtual Reality İnterventionvirtual reality intervention in addition to conventional occupational therapy intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- (1) age between 18 and 65 years,
- (2) Participants must have been diagnosed with Schizophrenia according to the ICD-10 diagnostic criteria,
- (3) Participants must be able to read and write at a level that will allow them to understand the content of the study,
- (4) There must be no severe cognitive impairment diagnosed that would prevent participation in the study,
- (5) Participants' antipsychotic treatments must be stable (no medication changes in the last 3 months),
Key exclusion criteria (7 listed)
- (1) Existence of additional diagnoses such as schizoaffective disorder, bipolar disorder or severe depressive disorder,
- (2) Existence of active substance or alcohol addiction diagnosed in the last 6 months,
- (3) Presence of diseases that may affect cognitive functions such as epilepsy, dementia, Parkinson's disease,
- (4) Exclusion of individuals who have active psychotic episodes or severe agitation during the study period,
- (5) Exclusion of individuals who are at risk of harming themselves or others,
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 |
|---|---|---|
| Conventional Occupational Therapy Interventiın1-2. Week: Occupation-based interventions for visual skills 3-6. Week: Social Skills Training 7-8. Week: Interventions for participation problems in ADLs | Behavioural | Control Group, Study Group |
| Virtual Reality İnterventionIn this study, the Xbox 360 gaming console and Kinect sensor were utilized for the virtual reality (VR) intervention. The Xbox 360 functions as an interactive gaming platform, while the Kinect sensor is a motion-detection device that captures users' positions and movements through an integrated camera and sensors. The selection of games for the VR intervention was conducted in collaboration with experts from various disciplines. The evaluation process considered the cognitive and functional demands required for successful gameplay, the potential skills each game could enhance, and the overall therapeutic purpose of the selected games. Following an independent assessment of each game, nine games were identified as suitable for the intervention. Given that all selected games shared similar functional requirements, participants were provided access to the full set of games to optimize engagement and motivation. | Behavioural | Study Group |
Primary outcome
The Loewenstein Occupational Therapy Cognitive Assessment (LOTCA)
Time frame: 1 hour
The LOTCA is a performance test that consists of 20 items. The test includes testing materials such as card decks, colored blocks, a pegboard set, and other items. Additionally, a manual is provided that defines the cognitive domains assessed and provides administration instructions, and specific scoring guidelines. The LOTCA was scored on a Likert-type scale from 1 to 4, except for items 1-5 which related to categorization, unstructured Risk Object Classification, and structured Risk Object Classification. Higher scores indicate better cognitive functions
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 8 Aug 2025.
- 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 Conventional Occupational Therapy Interventiın and Virtual Reality İntervention in people with Cognitive Ability General and Virtual Reality, run by Saglik Bilimleri Universitesi 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 6 inclusion and 7 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 8 Aug 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?
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?
The Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) (time frame: 1 hour). 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 8 Aug 2025.