NCT07027085

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 2, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

June 2, 2025

Last Update Submit

June 10, 2025

Conditions

Keywords

virtual realitysocial skill trainingcognitionsensory processing

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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

    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

    at the beginning (baseline) and end of the intervention (7 weeks)

Secondary Outcomes (2)

  • Scale for the Assessment of Positive Symptoms

    at the beginning (baseline) and end of the intervention (7 weeks)

  • Scale for the Assessment of Negative Symptoms

    at the beginning (baseline) and end of the intervention (7 weeks)

Study Arms (2)

intervention group

EXPERIMENTAL
Device: virtual reality

control group

NO INTERVENTION

Interventions

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.

intervention group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niğde Ömer Halisdemir University

Niğde, Turkey (Türkiye)

Location

Related Publications (26)

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    BACKGROUND
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    BACKGROUND
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    PMID: 12794644BACKGROUND
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    PMID: 28735593BACKGROUND
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    BACKGROUND
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    PMID: 27151071BACKGROUND
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    PMID: 31379623BACKGROUND
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    BACKGROUND
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    PMID: 32842579BACKGROUND
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    PMID: 18375568BACKGROUND
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    BACKGROUND
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    PMID: 35367989BACKGROUND
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    PMID: 15531405BACKGROUND
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    PMID: 19413446BACKGROUND
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    PMID: 23792865BACKGROUND
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    BACKGROUND
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MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 2, 2025

First Posted

June 18, 2025

Study Start

June 2, 2025

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations